Brompheniramine/Hydrocodone/Phenylephrine Liquid

Pronunciation: BROME-fen-IR-a-meen/hye-droe-KOE-done/FEN-il-EF-rin
Generic Name: Brompheniramine/Hydrocodone/Phenylephrine
Brand Name: Canges-HC

Brompheniramine/Hydrocodone/Phenylephrine Liquid is used for:

Relieving symptoms of sinus congestion, runny nose, sneezing, and cough due to colds, upper respiratory infections, and allergies. It may also be used for other conditions as determined by your doctor.

Brompheniramine/Hydrocodone/Phenylephrine Liquid is a decongestant, antihistamine, and cough suppressant combination. The decongestant works by constricting blood vessels and reducing swelling in the nasal passages. The antihistamine works by blocking the action of histamine, which helps reduce symptoms, such as watery eyes and sneezing. The cough suppressant works in the brain to help decrease the cough reflex, which reduces a dry cough.

Do NOT use Brompheniramine/Hydrocodone/Phenylephrine Liquid if:

• you are allergic to any ingredient in Brompheniramine/Hydrocodone/Phenylephrine Liquid or any other codeine- or morphine-related medicine (eg, codeine)


• you have severe high blood pressure, severe heart blood vessel disease, rapid heartbeat, or severe heart problems


• you are unable to urinate or are having an asthma attack


• you are taking sodium oxybate (GHB) or if you have taken furazolidone or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days

Contact your doctor or health care provider right away if any of these apply to you.

Before using Brompheniramine/Hydrocodone/Phenylephrine Liquid:

Some medical conditions may interact with Brompheniramine/Hydrocodone/Phenylephrine Liquid. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have a fast, slow, or irregular heartbeat; heart blood vessel problems; or other heart problems


• if you have a history of adrenal gland problems (eg, adrenal gland tumor); high blood pressure; diabetes; stroke; glaucoma; a blockage of your bladder, stomach, or intestines; ulcers; trouble urinating; an enlarged prostate or other prostate problems; or an overactive thyroid


• if you have a history of asthma, chronic cough, lung problems (eg, chronic bronchitis, emphysema), or chronic obstructive pulmonary disease (COPD), or if your cough occurs with large amounts of mucus


• if you have or recently have had any head or brain injury, brain tumor, increased pressure in the brain, infection of the brain or nervous system, epilepsy, or seizures


• if you have a history of stomach problems (eg, ulcers), bowel problems (eg, chronic inflammation or ulceration of the bowel), or gallbladder problems (eg, gallstones), or if you have had recent abdominal surgery


• if you have a history of alcohol or substance abuse or suicidal thoughts or behavior

Some MEDICINES MAY INTERACT with Brompheniramine/Hydrocodone/Phenylephrine Liquid. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Beta-blockers (eg, propranolol), catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), furazolidone, indomethacin, MAOIs (eg, phenelzine), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Brompheniramine/Hydrocodone/Phenylephrine Liquid's side effects


• Cimetidine, digoxin, droxidopa, or sodium oxybate (GHB ) because the risk of severe drowsiness, breathing problems, seizures, irregular heartbeat, or heart attack may be increased


• Naltrexone because it may decrease Brompheniramine/Hydrocodone/Phenylephrine Liquid's effectiveness


• Bromocriptine or hydantoins (eg, phenytoin) because the risk of their side effects may be increased by Brompheniramine/Hydrocodone/Phenylephrine Liquid


• Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Brompheniramine/Hydrocodone/Phenylephrine Liquid

This may not be a complete list of all interactions that may occur. Ask your health care provider if Brompheniramine/Hydrocodone/Phenylephrine Liquid may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Brompheniramine/Hydrocodone/Phenylephrine Liquid:

Use Brompheniramine/Hydrocodone/Phenylephrine Liquid as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Brompheniramine/Hydrocodone/Phenylephrine Liquid by mouth with or without food.


• Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.


• If you miss a dose of Brompheniramine/Hydrocodone/Phenylephrine Liquid, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Brompheniramine/Hydrocodone/Phenylephrine Liquid.

Important safety information:

• Brompheniramine/Hydrocodone/Phenylephrine Liquid may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Brompheniramine/Hydrocodone/Phenylephrine Liquid with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Brompheniramine/Hydrocodone/Phenylephrine Liquid without first checking with your doctor; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.


• Do not take diet or appetite control medicines while you are taking Brompheniramine/Hydrocodone/Phenylephrine Liquid without checking with your doctor.


• Brompheniramine/Hydrocodone/Phenylephrine Liquid has brompheniramine and phenylephrine in it. Before you start any new medicine, check the label to see if it has brompheniramine and phenylephrine in it too. If it does or if you are not sure, check with your doctor or pharmacist.


• Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.


• If your symptoms do not get better within 5 to 7 days or if they get worse, check with your doctor.


• Brompheniramine/Hydrocodone/Phenylephrine Liquid may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Brompheniramine/Hydrocodone/Phenylephrine Liquid. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.


• Brompheniramine/Hydrocodone/Phenylephrine Liquid may interfere with skin allergy tests. If you are scheduled for a skin test, talk to your doctor. You may need to stop taking Brompheniramine/Hydrocodone/Phenylephrine Liquid for a few days before the tests.


• Tell your doctor or dentist that you take Brompheniramine/Hydrocodone/Phenylephrine Liquid before you receive any medical or dental care, emergency care, or surgery.


• Use Brompheniramine/Hydrocodone/Phenylephrine Liquid with caution in the ELDERLY; they may be more sensitive to its effects.


• Caution is advised when using Brompheniramine/Hydrocodone/Phenylephrine Liquid in CHILDREN; they may be more sensitive to its effects.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Brompheniramine/Hydrocodone/Phenylephrine Liquid while you are pregnant. It is not known if Brompheniramine/Hydrocodone/Phenylephrine Liquid is found in breast milk. Do not breast-feed while taking Brompheniramine/Hydrocodone/Phenylephrine Liquid.

When used for long periods of time or at high doses, Brompheniramine/Hydrocodone/Phenylephrine Liquid may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Brompheniramine/Hydrocodone/Phenylephrine Liquid stops working well. Do not take more than prescribed.

When used for long periods of time or at high doses, some people develop a need to continue taking Brompheniramine/Hydrocodone/Phenylephrine Liquid. This is known as DEPENDENCE or addiction.

If you suddenly stop taking Brompheniramine/Hydrocodone/Phenylephrine Liquid, you may experience WITHDRAWAL symptoms including anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; nausea; vomiting; pain; rigid muscles; rapid heartbeat; seeing, hearing, or feeling things that are not there; shivering or tremors; sweating; and trouble sleeping.

Possible side effects of Brompheniramine/Hydrocodone/Phenylephrine Liquid:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; dizziness; drowsiness; excitability; headache; loss of appetite; nausea; nervousness or anxiety; upset stomach; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty urinating or inability to urinate; fast or irregular heartbeat; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; severe or persistent trouble sleeping; tremor; vision changes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Brompheniramine/Hydrocodone/Phenylephrine side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include blurred vision; confusion; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; unusually fast, slow, or irregular heartbeat; vomiting.

Proper storage of Brompheniramine/Hydrocodone/Phenylephrine Liquid:

Store Brompheniramine/Hydrocodone/Phenylephrine Liquid at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Brompheniramine/Hydrocodone/Phenylephrine Liquid out of the reach of children and away from pets.

General information:

• If you have any questions about Brompheniramine/Hydrocodone/Phenylephrine Liquid, please talk with your doctor, pharmacist, or other health care provider.


• Brompheniramine/Hydrocodone/Phenylephrine Liquid is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Brompheniramine/Hydrocodone/Phenylephrine Liquid. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Brompheniramine/Hydrocodone/Phenylephrine resources

• Brompheniramine/Hydrocodone/Phenylephrine Side Effects (in more detail)
• Brompheniramine/Hydrocodone/Phenylephrine Use in Pregnancy & Breastfeeding
• Brompheniramine/Hydrocodone/Phenylephrine Drug Interactions
• Brompheniramine/Hydrocodone/Phenylephrine Support Group
• 0 Reviews for Brompheniramine/Hydrocodone/Phenylephrine - Add your own review/rating

Compare Brompheniramine/Hydrocodone/Phenylephrine with other medications

• Cough and Nasal Congestion

Lice Care

Lice Care may be available in the countries listed below.

Ingredient matches for Lice Care

Malathion

Malathion is reported as an ingredient of Lice Care in the following countries:

• Singapore

International Drug Name Search

Dyspagon

Dyspagon may be available in the countries listed below.

Ingredient matches for Dyspagon

Loperamide

Loperamide hydrochloride (a derivative of Loperamide) is reported as an ingredient of Dyspagon in the following countries:

• Algeria


• France


• Luxembourg

International Drug Name Search

Sophivir

Sophivir may be available in the countries listed below.

Ingredient matches for Sophivir

Acyclovir

Aciclovir is reported as an ingredient of Sophivir in the following countries:

• Costa Rica


• Dominican Republic


• El Salvador


• Guatemala


• Honduras


• Mexico


• Nicaragua


• Panama

International Drug Name Search

Bleomedac

Bleomedac may be available in the countries listed below.

Ingredient matches for Bleomedac

Bleomycin

Bleomycin sulfate (a derivative of Bleomycin) is reported as an ingredient of Bleomedac in the following countries:

• Germany

International Drug Name Search

Risperdal Solution

Pronunciation: ris-PER-i-done
Generic Name: Risperidone
Brand Name: Risperdal

Risperdal Solution is an atypical antipsychotic. It may increase the risk of death when used to treat mental problems caused by dementia in elderly patients. Most of the deaths were linked to heart problems or infection. Risperdal Solution is not approved to treat mental problems caused by dementia.

Risperdal Solution is used for:

Treating schizophrenia or bipolar disorder. It is used to treat irritability caused by autistic disorder. It may also be used for other conditions as determined by your doctor.

Risperdal Solution is an atypical antipsychotic. It works by affecting certain substances in the brain.

Do NOT use Risperdal Solution if:

• you are allergic to any ingredient in Risperdal Solution

Contact your doctor or health care provider right away if any of these apply to you.

Before using Risperdal Solution:

Some medical conditions may interact with Risperdal Solution. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have a history of seizures, heart problems (eg, heart failure, slow or irregular heartbeat), abnormal electrocardiogram (ECG), heart attack, stroke, blood vessel problems, high or low blood pressure, high cholesterol or triglyceride levels, or low white blood cell levels


• if you have a history of kidney or liver problems, stomach or bowel problems (eg, narrowing, blockage), neuroleptic malignant syndrome (NMS), suicidal thoughts or attempts, or alcohol abuse or dependence


• if you have diabetes or are very overweight, or if a family member has had diabetes


• if you have Alzheimer disease, dementia, Parkinson disease, or esophagus problems (eg, trouble swallowing)


• if you have had high blood prolactin levels or a history of certain types of cancer (eg, breast, pancreas, pituitary, brain), or if you are at risk for breast cancer


• if you are dehydrated, drink alcohol, or will be exposed to very high or very low temperatures

Some MEDICINES MAY INTERACT with Risperdal Solution. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Alpha-blockers (eg, doxazosin) or medicine for high blood pressure because the risk of low blood pressure and fainting may be increased


• Anticholinergics (eg, scopolamine) because the risk of overheating may be increased


• Tramadol because the risk of seizures may be increased


• Clozapine or selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine, paroxetine) because they may increase the risk of Risperdal Solution's side effects


• Carbamazepine, phenobarbital, phenytoin, or rifampin because they may decrease Risperdal Solution's effectiveness


• Dopamine receptor agonists (eg, pramipexole) or levodopa because their effectiveness may be decreased by Risperdal Solution

This may not be a complete list of all interactions that may occur. Ask your health care provider if Risperdal Solution may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Risperdal Solution:

Use Risperdal Solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Risperdal Solution by mouth with or without food.


• Use the dropper that comes with Risperdal Solution to measure your dose. Ask your pharmacist for help if you are unsure how to measure your dose.


• Take Risperdal Solution with water, coffee, orange juice, or low-fat milk. Do NOT take Risperdal Solution with cola or tea.


• Take Risperdal Solution on a regular schedule to get the most benefit from it. Taking Risperdal Solution at the same time each day will help you remember to take it.


• Continue to take Risperdal Solution even if you feel well. Do not miss any doses.


• If you miss a dose of Risperdal Solution, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Risperdal Solution.

Important safety information:

• Risperdal Solution may cause drowsiness, dizziness, light-headedness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Risperdal Solution with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Do not drink alcohol while you are using Risperdal Solution.


• Check with your doctor before taking medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Risperdal Solution; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.


• Risperdal Solution may cause dizziness, light-headedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.


• Do not become overheated in hot weather or while you are being active; heatstroke may occur.


• Patients who have bipolar (manic-depressive) illness, or if their family members have had it, may be at increased risk for suicidal thoughts or actions. Watch patients who take Risperdal Solution closely. Contact the doctor at once if new, worsened, or sudden symptoms such as anxious, restless, or irritable behavior; depressed mood; panic attacks; or any unusual change in mood or behavior occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur.


• Risperdal Solution may raise your blood sugar. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away.


• Diabetes patients - Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.


• Risperdal Solution may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.


• NMS is a possibly fatal syndrome that can be caused by Risperdal Solution. Symptoms may include fever; stiff muscles; confusion; abnormal thinking; fast or irregular heartbeat; or sweating. Contact your doctor at once if you have any of these symptoms.


• Some patients who take Risperdal Solution may develop muscle movements that they cannot control. This is more likely to happen in elderly patients, especially women. The chance that this will happen or that it will become permanent is greater in those who take Risperdal Solution in higher doses or for a long time. Muscle problems may also occur after short-term treatment with low doses. Tell your doctor at once if you have muscle problems with your arms; legs; or your tongue, face, mouth, or jaw (eg, tongue sticking out, puffing of cheeks, mouth puckering, chewing movements) while taking Risperdal Solution.


• Risperdal Solution may increase the amount of a certain hormone (prolactin) in your blood. Symptoms may include enlarged breasts, missed menstrual period, decreased sexual ability, or nipple discharge. Contact your doctor right away if you experience any of these symptoms.


• Risperdal Solution may rarely cause a prolonged, painful erection. This could happen even when you are not having sex. If this is not treated right away, it could lead to permanent sexual problems such as impotence. Contact your doctor right away if this happens.


• Lab tests, including fasting blood glucose and complete blood cell counts, may be performed while you use Risperdal Solution. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Risperdal Solution may cause weight gain. Your weight may need to be monitored while you take Risperdal Solution.


• Use Risperdal Solution with caution in the ELDERLY; they may be more sensitive to its effects, especially dizziness when standing or uncontrolled muscles movements.


• Risperdal Solution should be used with extreme caution in CHILDREN younger than 5 years old; safety and effectiveness in these children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Risperdal Solution while you are pregnant. Using Risperdal Solution during the third trimester may result in uncontrolled muscle movements or withdrawal symptoms in the newborn. Discuss any questions or concerns with your doctor. Risperdal Solution is found in breast milk. Do not breast-feed while taking Risperdal Solution.

Possible side effects of Risperdal Solution:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Anxiety; constipation; cough; diarrhea; dizziness; drowsiness; dry mouth; fatigue; headache; increased appetite; increased saliva production; indigestion; light-headedness; nausea; restlessness; runny nose; stomach pain or upset; trouble sleeping; vomiting; weight gain.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, or tongue, unusual hoarseness); abnormal thoughts; confusion; drooling; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; inability to control urination; increased sweating; new or worsening mental or mood changes (eg, aggression, agitation, depression, severe anxiety); seizures; severe dizziness; stiff or rigid muscles; suicidal thoughts or attempts; symptoms of high blood sugar (eg, increased thirst, hunger, or urination; unusual weakness); tremor; trouble concentrating, speaking, or swallowing; trouble sitting still; trouble walking or standing; uncontrolled muscle movements (eg, arm or leg movements, twitching of the face or tongue, jerking or twisting); unusual bruising; vision changes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Risperdal side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include fast or irregular heartbeat; severe drowsiness or dizziness; unusual muscle movements.

Proper storage of Risperdal Solution:

Store Risperdal Solution between 59 and 77 degrees F (15 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Risperdal Solution out of the reach of children and away from pets.

General information:

• If you have any questions about Risperdal Solution, please talk with your doctor, pharmacist, or other health care provider.


• Risperdal Solution is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Risperdal Solution. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Risperdal resources

• Risperdal Side Effects (in more detail)
• Risperdal Use in Pregnancy & Breastfeeding
• Drug Images
• Risperdal Drug Interactions
• Risperdal Support Group
• 74 Reviews for Risperdal - Add your own review/rating

Compare Risperdal with other medications

• Asperger Syndrome
• Autism
• Bipolar Disorder
• Mania
• Schizoaffective Disorder
• Schizophrenia

Mégamag

Mégamag may be available in the countries listed below.

Ingredient matches for Mégamag

Magnesium Hydrogen Aspartate

Magnesium Hydrogen Aspartate dihydrate (a derivative of Magnesium Hydrogen Aspartate) is reported as an ingredient of Mégamag in the following countries:

• France


• Tunisia

International Drug Name Search

Neuropyl

Neuropyl may be available in the countries listed below.

Ingredient matches for Neuropyl

Piracetam

Piracetam is reported as an ingredient of Neuropyl in the following countries:

• Vietnam

International Drug Name Search

Niacex-S Isdin

Niacex-S Isdin may be available in the countries listed below.

Ingredient matches for Niacex-S Isdin

Nicotinamide

Nicotinamide is reported as an ingredient of Niacex-S Isdin in the following countries:

• Chile

International Drug Name Search

Duostop

Duostop may be available in the countries listed below.

Ingredient matches for Duostop

Dorzolamide

Dorzolamide hydrochloride (a derivative of Dorzolamide) is reported as an ingredient of Duostop in the following countries:

• Peru

International Drug Name Search

Spirolon

Spirolon may be available in the countries listed below.

Ingredient matches for Spirolon

Spironolactone

Spironolactone is reported as an ingredient of Spirolon in the following countries:

• Cyprus


• Kenya


• Sudan


• Zimbabwe

International Drug Name Search

Ropivacaine

In the US, Ropivacaine (ropivacaine systemic) is a member of the drug class local injectable anesthetics and is used to treat Cesarean Section, Labor Pain and Local Anesthesia.

US matches:

• Ropivacaine


• Ropivacaine Injection

Scheme

Rec.INN

ATC (Anatomical Therapeutic Chemical Classification)

N01BB09

CAS registry number (Chemical Abstracts Service)

0084057-95-4

Chemical Formula

C17-H26-N2-O

Molecular Weight

274

Therapeutic Category

Anesthetic, local

Chemical Name

(-)-1-Propyl-2',6'-pipecoloxylidide

Foreign Names

• Ropivacainum (Latin)
• Ropivacain (German)
• Ropivacaine (French)
• Ropivacaina (Spanish)

Generic Names

• Ropivacaine (OS: BAN, USAN)
• AL 281 (IS)
• Ropivacaine Hydrochloride (OS: BANM)
• Ropivacaine Hydrochloride (PH: USP 32)
• Ropivacaine Hydrochloride Monohydrate (PH: Ph. Eur. 6, BP 2010)
• Ropivacaini hydrochloridum monohydricum (PH: Ph. Eur. 6)

Brand Names

• Naropin
  AstraZeneca, Cyprus; AstraZeneca, Egypt; AstraZeneca, Guyana; AstraZeneca, Jordan; AstraZeneca, Libya



• Anapeine
  AstraZeneca, Japan



• Narop
  AstraZeneca, Israel; AstraZeneca, Sweden



• Naropeine
  AstraZeneca, France; AstraZeneca, Portugal; Cana, Greece



• Naropin with Fentanyl (Ropivacaine and Fenatnyl)
  AstraZeneca, Australia; AstraZeneca, New Zealand



• Naropin
  APP, United States; AstraZeneca, United Arab Emirates; AstraZeneca, Argentina; AstraZeneca, Austria; AstraZeneca, Australia; AstraZeneca, Belgium; AstraZeneca, Bahrain; AstraZeneca, Brazil; AstraZeneca, Canada; AstraZeneca, Switzerland; AstraZeneca, Chile; AstraZeneca, China; AstraZeneca, Czech Republic; AstraZeneca, Germany; AstraZeneca, Denmark; AstraZeneca, Spain; AstraZeneca, Finland; AstraZeneca, United Kingdom; AstraZeneca, Georgia; AstraZeneca, Hong Kong; AstraZeneca, Hungary; AstraZeneca, Indonesia; AstraZeneca, Israel; AstraZeneca, Iraq; AstraZeneca, Iceland; AstraZeneca, Kuwait; AstraZeneca, Lebanon; AstraZeneca, Luxembourg; AstraZeneca, Malaysia; AstraZeneca, Netherlands; AstraZeneca, Norway; AstraZeneca, New Zealand; AstraZeneca, Oman; AstraZeneca, Philippines; AstraZeneca, Poland; AstraZeneca, Qatar; AstraZeneca, Romania; AstraZeneca, Russian Federation; AstraZeneca, Saudi Arabia; AstraZeneca, Singapore; AstraZeneca, Syria; AstraZeneca, Yemen; AstraZeneca, South Africa; Representaciones e Investigaciones Medicas, Mexico



• Naropina
  AstraZeneca, Italy



• Ropivacain-HCl-ratiopharm
  Ratiopharm, Germany

International Drug Name Search

Glossary

BAN	British Approved Name
BANM	British Approved Name (Modified)
IS	Inofficial Synonym
OS	Official Synonym
PH	Pharmacopoeia Name
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)
USAN	United States Adopted Name

Click for further information on drug naming conventions and International Nonproprietary Names.

Neural

Neural may be available in the countries listed below.

Ingredient matches for Neural

Bromazepam

Bromazepam is reported as an ingredient of Neural in the following countries:

• Brazil

Mecobalamin

Mecobalamin is reported as an ingredient of Neural in the following countries:

• Bangladesh

International Drug Name Search

Troxerutin Sopharma

Troxerutin Sopharma may be available in the countries listed below.

Ingredient matches for Troxerutin Sopharma

Troxerutin

Troxerutin is reported as an ingredient of Troxerutin Sopharma in the following countries:

• Bulgaria


• Georgia

International Drug Name Search

Citalopram Interpharm

Citalopram Interpharm may be available in the countries listed below.

Ingredient matches for Citalopram Interpharm

Citalopram

Citalopram hydrobromide (a derivative of Citalopram) is reported as an ingredient of Citalopram Interpharm in the following countries:

• Austria

International Drug Name Search

Stronghold

Stronghold may be available in the countries listed below.

In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Stronghold

Selamectin

Selamectin is reported as an ingredient of Stronghold in the following countries:

• Austria


• Belgium


• Finland


• France


• Germany


• Italy


• Norway


• Portugal


• Sweden


• Switzerland


• United Kingdom

International Drug Name Search

Nifedipin-ratiopharm

Nifedipin-ratiopharm may be available in the countries listed below.

Ingredient matches for Nifedipin-ratiopharm

Nifedipine

Nifedipine is reported as an ingredient of Nifedipin-ratiopharm in the following countries:

• Estonia


• Germany


• Luxembourg

International Drug Name Search

Dilrène LP

Dilrène LP may be available in the countries listed below.

Ingredient matches for Dilrène LP

Diltiazem

Diltiazem hydrochloride (a derivative of Diltiazem) is reported as an ingredient of Dilrène LP in the following countries:

• France

International Drug Name Search

Nifuratel

Scheme

Rec.INN

ATC (Anatomical Therapeutic Chemical Classification)

G01AX05

CAS registry number (Chemical Abstracts Service)

0004936-47-4

Chemical Formula

C10-H11-N3-O5-S

Molecular Weight

285

Therapeutic Categories

Antiprotozoal agent: Trichomonacidal

Antibacterial: Nitrofuran-derivative

Chemical Name

2-Oxazolidinone, 5-[(methylthio)methyl]-3-[[(5-nitro-2-furanyl)methylene]amino]-

Foreign Names

• Nifuratelum (Latin)
• Nifuratel (German)
• Nifuratel (French)
• Nifuratel (Spanish)

Generic Names

• Nifuratel (OS: USAN, DCIT, DCF, BAN)
• Methylmercadone (IS)
• NF 113 (IS)
• SAP 113 (IS)

Brand Names

• Inimur
  Taurus, Germany



• Macmiror
  CSC, Bulgaria; CSC, Russian Federation; Doppel, Bulgaria; Doppel, Czech Republic; Doppel, Romania; Harvester, Taiwan; Italmex, Mexico; Marvecs, Italy; Poli, Georgia; Poli, Lithuania; Poli, Poland; Polichem, Slovakia; U.S. Summit, Hong Kong



• Macmiror (Nifuratel and Nystatin)
  Polichem, Slovakia

International Drug Name Search

Glossary

BAN	British Approved Name
DCF	Dénomination Commune Française
DCIT	Denominazione Comune Italiana
IS	Inofficial Synonym
OS	Official Synonym
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)
USAN	United States Adopted Name

Click for further information on drug naming conventions and International Nonproprietary Names.

Spirapril Hydrochloride

Spirapril Hydrochloride may be available in the countries listed below.

Ingredient matches for Spirapril Hydrochloride

Spirapril

Spirapril Hydrochloride (BANM, USAN) is also known as Spirapril (Rec.INN)

International Drug Name Search

Glossary

BANM	British Approved Name (Modified)
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)
USAN	United States Adopted Name

Click for further information on drug naming conventions and International Nonproprietary Names.

Neoacetilsalicilo rugistis

Neoacetilsalicilo rugistis may be available in the countries listed below.

Ingredient matches for Neoacetilsalicilo rugistis

Aspirin

Acetylsalicylic Acid is reported as an ingredient of Neoacetilsalicilo rugistis in the following countries:

• Lithuania

International Drug Name Search

Toraass A

Toraass A may be available in the countries listed below.

Ingredient matches for Toraass A

Amlodipine

Amlodipine besilate (a derivative of Amlodipine) is reported as an ingredient of Toraass A in the following countries:

• Vietnam

Losartan

Losartan potassium salt (a derivative of Losartan) is reported as an ingredient of Toraass A in the following countries:

• Vietnam

International Drug Name Search

Sofra-Tulle

Sofra-Tulle may be available in the countries listed below.

Ingredient matches for Sofra-Tulle

Framycetin

Framycetin sulfate (a derivative of Framycetin) is reported as an ingredient of Sofra-Tulle in the following countries:

• Bangladesh


• India


• Indonesia


• Israel


• Oman


• Thailand

International Drug Name Search

Avita

Avita is a brand name of tretinoin topical, approved by the FDA in the following formulation(s):

AVITA (tretinoin - cream; topical)

• 
  Manufacturer: MYLAN BERTEK
  
  Approval date: January 14, 1997
  
  Strength(s): 0.025% ^[AB]

Has a generic version of Avita been approved?

Yes. The following products are equivalent to Avita:

tretinoin cream; topical

• 
  Manufacturer: TRIAX PHARMS LLC
  
  Approval date: December 24, 1998
  
  Strength(s): 0.025% ^[AB]

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Avita. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: About generic drugs.

Related Patents

There are no current U.S. patents associated with Avita.

See also...

• Avita Cream Consumer Information (Wolters Kluwer)
• Avita Gel Consumer Information (Wolters Kluwer)
• Avita Consumer Information (Cerner Multum)
• Avita Topical Advanced Consumer Information (Micromedex)
• Retin A Consumer Information (Drugs.com)
• Tretinoin Cream Consumer Information (Wolters Kluwer)
• Tretinoin Emollient Cream Consumer Information (Wolters Kluwer)
• Tretinoin Gel Consumer Information (Wolters Kluwer)
• Tretinoin Liquid Consumer Information (Wolters Kluwer)
• Tretinoin topical Consumer Information (Cerner Multum)
• Rejuva-A Topical Advanced Consumer Information (Micromedex)
• Retin-A Micro Topical Advanced Consumer Information (Micromedex)
• Vitamin A Acid Topical Advanced Consumer Information (Micromedex)
• Tretinoin Topical Advanced Consumer Information (Micromedex)
• Tretinoin topical AHFS DI Monographs (ASHP)

Pharex Hydrocortisone

Pharex Hydrocortisone may be available in the countries listed below.

Ingredient matches for Pharex Hydrocortisone

Hydrocortisone

Hydrocortisone 17α-butyrate (a derivative of Hydrocortisone) is reported as an ingredient of Pharex Hydrocortisone in the following countries:

• Philippines

International Drug Name Search

Xylocaine Topical

In the US, Xylocaine Topical (lidocaine topical) is a member of the drug class topical anesthetics and is used to treat Anal Itching, Anesthesia, Burns - External, Hemorrhoids, Pain, Pruritus and Sunburn.

US matches:

• Xylocaine Topical


• Xylocaine Topical application


• Xylocaine Topical Solution

Ingredient matches for Xylocaine Topical

Lidocaine

Lidocaine hydrochloride (a derivative of Lidocaine) is reported as an ingredient of Xylocaine Topical in the following countries:

• New Zealand


• Thailand

International Drug Name Search

Lastuss-LA

Lastuss-LA may be available in the countries listed below.

Ingredient matches for Lastuss-LA

Dextromethorphan

Dextromethorphan hydrobromide (a derivative of Dextromethorphan) is reported as an ingredient of Lastuss-LA in the following countries:

• India


• Sri Lanka

International Drug Name Search

Mésoridazine

Mésoridazine may be available in the countries listed below.

Ingredient matches for Mésoridazine

Mesoridazine

Mésoridazine (DCF) is known as Mesoridazine in the US.

International Drug Name Search

Glossary

DCF	Dénomination Commune Française

Click for further information on drug naming conventions and International Nonproprietary Names.

Dafalgan Enfant

Dafalgan Enfant may be available in the countries listed below.

Ingredient matches for Dafalgan Enfant

Paracetamol

Paracetamol is reported as an ingredient of Dafalgan Enfant in the following countries:

• Belgium

International Drug Name Search

Anxetin

Anxetin may be available in the countries listed below.

Ingredient matches for Anxetin

Fluoxetine

Fluoxetine is reported as an ingredient of Anxetin in the following countries:

• Tunisia

Fluoxetine hydrochloride (a derivative of Fluoxetine) is reported as an ingredient of Anxetin in the following countries:

• Bahrain


• Iraq


• Jordan


• Kuwait


• Lebanon


• Libya


• Nigeria


• Oman


• Qatar


• Romania


• Saudi Arabia


• Somalia


• Sudan


• United Arab Emirates


• Yemen

International Drug Name Search

Hipoge

Hipoge may be available in the countries listed below.

Ingredient matches for Hipoge

Hydrocortisone

Hydrocortisone 21-acetate (a derivative of Hydrocortisone) is reported as an ingredient of Hipoge in the following countries:

• Chile

International Drug Name Search

Netunal

Netunal may be available in the countries listed below.

Ingredient matches for Netunal

Sucralfate

Sucralfate is reported as an ingredient of Netunal in the following countries:

• Argentina

International Drug Name Search

Cateptin

Cateptin may be available in the countries listed below.

Ingredient matches for Cateptin

Procaterol

Procaterol hydrochloride hemihydrate (a derivative of Procaterol) is reported as an ingredient of Cateptin in the following countries:

• Japan

International Drug Name Search

Nulobes

Nulobes may be available in the countries listed below.

Ingredient matches for Nulobes

Tiratricol

Tiratricol is reported as an ingredient of Nulobes in the following countries:

• Argentina

International Drug Name Search

Coforta

Coforta may be available in the countries listed below.

In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Coforta

Butafosfan

Butafosfan is reported as an ingredient of Coforta in the following countries:

• Australia


• New Zealand

Cyanocobalamin

Cyanocobalamin is reported as an ingredient of Coforta in the following countries:

• Australia


• New Zealand

International Drug Name Search

Thicataren

Thicataren may be available in the countries listed below.

Ingredient matches for Thicataren

Diclofenac

Diclofenac sodium salt (a derivative of Diclofenac) is reported as an ingredient of Thicataren in the following countries:

• Japan

International Drug Name Search

Sildenafilo Colmed

Sildenafilo Colmed may be available in the countries listed below.

Ingredient matches for Sildenafilo Colmed

Sildenafil

Sildenafil citrate (a derivative of Sildenafil) is reported as an ingredient of Sildenafilo Colmed in the following countries:

• Colombia

International Drug Name Search

Neuzyme

Neuzyme may be available in the countries listed below.

Ingredient matches for Neuzyme

Lysozyme

Lysozyme hydrochloride (a derivative of Lysozyme) is reported as an ingredient of Neuzyme in the following countries:

• Japan

International Drug Name Search

Pen 30

Pen 30 may be available in the countries listed below.

In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Pen 30

Benzylpenicillin

Benzylpenicillin procaine (a derivative of Benzylpenicillin) is reported as an ingredient of Pen 30 in the following countries:

• Belgium


• Netherlands

International Drug Name Search

Dilt-XR 24-Hour Sustained-Release Capsules

Pronunciation: dil-TYE-a-zem
Generic Name: Diltiazem
Brand Name: Examples include Diltia XT and Dilt-XR

Dilt-XR 24-Hour Sustained-Release Capsules are used for:

Treating high blood pressure and chronic stable angina (chest pain). It may be used alone or in combination with other medicines. It may also be used for other conditions as determined by your doctor.

Dilt-XR 24-Hour Sustained-Release Capsules are a calcium channel blocker. It works by relaxing (dilating) your blood vessels, lowering blood pressure, and decreasing heart rate, which lowers the workload of the heart. It also dilates coronary arteries, which increases blood flow to the heart.

Do NOT use Dilt-XR 24-Hour Sustained-Release Capsules if:

• you are allergic to any ingredient in Dilt-XR 24-Hour Sustained-Release Capsules


• you have certain heart problems (eg, sick sinus syndrome, second- or third-degree heart block) and do not have a pacemaker, you have very low blood pressure, or you have fluid buildup in the lungs during or soon after a heart attack


• you are taking erythromycin

Contact your doctor or health care provider right away if any of these apply to you.

Before using Dilt-XR 24-Hour Sustained-Release Capsules:

Some medical conditions may interact with Dilt-XR 24-Hour Sustained-Release Capsules. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have heart failure, a recent heart attack with lung congestion, heart block, a very slow heart rate, or other heart problems; low blood pressure; certain stomach or intestine problems (eg, narrowing); liver disease; or kidney problems


• if you are taking other medicines for high blood pressure or heart conditions

Some MEDICINES MAY INTERACT with Dilt-XR 24-Hour Sustained-Release Capsules. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Antiarrhythmics (eg, amiodarone, dronedarone), cimetidine, clonidine, HIV protease inhibitors (eg, atazanavir, indinavir), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Dilt-XR 24-Hour Sustained-Release Capsules's side effects, such as heart rhythm problems


• Benzodiazepines (eg, alprazolam), beta-blockers (eg, propranolol), buspirone, carbamazepine, cilostazol, cisapride, colchicine, corticosteroids (eg, hydrocortisone), cyclosporine, digoxin, everolimus, fentanyl, HMG-CoA reductase inhibitors (eg, simvastatin), hydantoins (eg, phenytoin), lurasidone, macrolide antibiotics (eg, erythromycin ), macrolide immunosuppressants (eg, tacrolimus), nifedipine, quinidine, ranolazine, theophylline, or vasopressin antagonists (eg, tolvaptan) because the risk of their side effects, some potentially life-threatening, may be increased by Dilt-XR 24-Hour Sustained-Release Capsules


• Moricizine or rifamycins (eg, rifampin) because they may decrease Dilt-XR 24-Hour Sustained-Release Capsules's effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if Dilt-XR 24-Hour Sustained-Release Capsules may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Dilt-XR 24-Hour Sustained-Release Capsules:

Use Dilt-XR 24-Hour Sustained-Release Capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Dilt-XR 24-Hour Sustained-Release Capsules by mouth on an empty stomach at least 1 hour before or 2 hours after eating.


• Swallow Dilt-XR 24-Hour Sustained-Release Capsules whole. Do not open, break, crush, or chew before swallowing.


• Taking Dilt-XR 24-Hour Sustained-Release Capsules at the same time each day will help you remember to take it.


• Continue to take Dilt-XR 24-Hour Sustained-Release Capsules even if you feel well. Do not miss any doses.


• If you miss a dose of Dilt-XR 24-Hour Sustained-Release Capsules, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Dilt-XR 24-Hour Sustained-Release Capsules.

Important safety information:

• Dilt-XR 24-Hour Sustained-Release Capsules may cause dizziness, lightheadedness, or drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use Dilt-XR 24-Hour Sustained-Release Capsules with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Dilt-XR 24-Hour Sustained-Release Capsules may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.


• Dilt-XR 24-Hour Sustained-Release Capsules may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Dilt-XR 24-Hour Sustained-Release Capsules. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.


• Patients who take medicine for high blood pressure often feel tired or run down for a few weeks after starting treatment. Be sure to take your medicine even if you may not feel "normal." Tell your doctor if you develop any new symptoms.


• Do not suddenly stop taking Dilt-XR 24-Hour Sustained-Release Capsules. Your condition may get worse if you suddenly stop taking it. If you need to stop Dilt-XR 24-Hour Sustained-Release Capsules or add a new medicine, your doctor will gradually lower your dose.


• Tell your doctor or dentist that you take Dilt-XR 24-Hour Sustained-Release Capsules before you receive any medical or dental care, emergency care, or surgery.


• Be sure to have your blood pressure checked regularly while taking Dilt-XR 24-Hour Sustained-Release Capsules.


• Lab tests, including blood pressure, electrocardiogram (ECG), and heart rate, may be performed while you use Dilt-XR 24-Hour Sustained-Release Capsules. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Dilt-XR 24-Hour Sustained-Release Capsules with caution in the ELDERLY; they may be more sensitive to its effects, especially swelling of the ankles, feet, or hands; dizziness; and slow heartbeat.


• Dilt-XR 24-Hour Sustained-Release Capsules should be used with extreme caution in CHILDREN; safety and effectiveness have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Dilt-XR 24-Hour Sustained-Release Capsules while you are pregnant. Dilt-XR 24-Hour Sustained-Release Capsules are found in breast milk. Do not breast-feed while taking Dilt-XR 24-Hour Sustained-Release Capsules.

Possible side effects of Dilt-XR 24-Hour Sustained-Release Capsules:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; dizziness; facial flushing; headache; lightheadedness; tiredness; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); chest pain; fainting; fast, slow, or irregular heartbeat; fever, chills, or sore throat; hallucinations; mental or mood changes; personality changes; reddened, blistered, or swollen skin; severe or persistent dizziness, lightheadedness, nausea, or vomiting; shortness of breath; sudden weight gain; swelling of the feet, ankles, or hands; symptoms of liver problems (eg, dark urine, pale stools, yellowing of the skin or eyes); tender, bleeding, or swollen gums; unusual bleeding or bruising; unusual or persistent tiredness or weakness; vision changes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Dilt-XR side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include confusion; difficulty breathing, especially when lying down; dizziness; drowsiness; fainting; lightheadedness, especially when standing; loss of consciousness; nausea; nervousness; slurred speech; unusual weakness; very slow heart rate.

Proper storage of Dilt-XR 24-Hour Sustained-Release Capsules:

Store Dilt-XR 24-Hour Sustained-Release Capsules at room temperature, between 59 and 77 degrees F (15 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Dilt-XR 24-Hour Sustained-Release Capsules out of the reach of children and away from pets.

General information:

• If you have any questions about Dilt-XR 24-Hour Sustained-Release Capsules, please talk with your doctor, pharmacist, or other health care provider.


• Dilt-XR 24-Hour Sustained-Release Capsules are to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Dilt-XR 24-Hour Sustained-Release Capsules. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Dilt-XR resources

• Dilt-XR Side Effects (in more detail)
• Dilt-XR Use in Pregnancy & Breastfeeding
• Dilt-XR Drug Interactions
• Dilt-XR Support Group
• 0 Reviews for Dilt-XR - Add your own review/rating

Compare Dilt-XR with other medications

• Angina Pectoris Prophylaxis
• Atrial Fibrillation
• Atrial Flutter
• Heart Failure
• High Blood Pressure
• Raynaud's Syndrome
• Supraventricular Tachycardia

Bonec

Bonec may be available in the countries listed below.

Ingredient matches for Bonec

Calcium Carbonate

Calcium Carbonate is reported as an ingredient of Bonec in the following countries:

• Bangladesh

International Drug Name Search

Nifedipine LA

Nifedipine LA may be available in the countries listed below.

Ingredient matches for Nifedipine LA

Nifedipine

Nifedipine is reported as an ingredient of Nifedipine LA in the following countries:

• Singapore

International Drug Name Search

Sertralina Tad

Sertralina Tad may be available in the countries listed below.

Ingredient matches for Sertralina Tad

Sertraline

Sertraline is reported as an ingredient of Sertralina Tad in the following countries:

• Italy

International Drug Name Search

Bunamidine

In some countries, this medicine may only be approved for veterinary use.

Scheme

Rec.INN

CAS registry number (Chemical Abstracts Service)

0003748-77-4

Chemical Formula

C25-H38-N2-O

Molecular Weight

382

Therapeutic Category

Anthelmintic

Chemical Name

1-Naphthalenecarboximidamide, N,N-dibutyl-4-(hexyloxy)-

Foreign Names

• Bunamidinum (Latin)
• Bunamidin (German)
• Bunamidine (French)
• Bunamidina (Spanish)

Generic Names

• Bunamidine (OS: BAN)
• BW 62415 (IS)
• Bunamidine Hydrochloride (OS: USAN, BANM)

Brand Name

• Scolaban (veterinary use)
  Schering-Plough Animal Health, United States

International Drug Name Search

Glossary

BAN	British Approved Name
BANM	British Approved Name (Modified)
IS	Inofficial Synonym
OS	Official Synonym
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)
USAN	United States Adopted Name

Click for further information on drug naming conventions and International Nonproprietary Names.

Fuszemin CP

Fuszemin CP may be available in the countries listed below.

Ingredient matches for Fuszemin CP

Pentoxyverine

Pentoxyverine citrate (a derivative of Pentoxyverine) is reported as an ingredient of Fuszemin CP in the following countries:

• Japan

International Drug Name Search

Neosynesin

Neosynesin may be available in the countries listed below.

Ingredient matches for Neosynesin

Phenylephrine

Phenylephrine hydrochloride (a derivative of Phenylephrine) is reported as an ingredient of Neosynesin in the following countries:

• Japan

International Drug Name Search

Nagel Batrafen

Nagel Batrafen may be available in the countries listed below.

Ingredient matches for Nagel Batrafen

Ciclopirox

Ciclopirox is reported as an ingredient of Nagel Batrafen in the following countries:

• Germany

International Drug Name Search

Surfactol

Surfactol may be available in the countries listed below.

In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Surfactol

Docusate

Docusate Sodium is reported as an ingredient of Surfactol in the following countries:

• South Africa

International Drug Name Search

Nifurantin

Nifurantin may be available in the countries listed below.

Ingredient matches for Nifurantin

Nitrofurantoin

Nitrofurantoin is reported as an ingredient of Nifurantin in the following countries:

• Germany


• Israel

International Drug Name Search

Nistax

Nistax may be available in the countries listed below.

Ingredient matches for Nistax

Nystatin

Nystatin is reported as an ingredient of Nistax in the following countries:

• Brazil

International Drug Name Search

Neviran

Neviran may be available in the countries listed below.

Ingredient matches for Neviran

Acyclovir

Aciclovir is reported as an ingredient of Neviran in the following countries:

• Italy

International Drug Name Search

Rescon JR

Dosage Form: tablet, multilayer, extended release
RESCON-Jr.®

DESCRIPTION

Nasal Decongestant / Antihistamine, sustained-release tablets for oral administration.

Each RESCON-Jr.® tablet contains:

Phenylephrine Hydrochloride               20 mg

Dexchlorpheniramine Maleate                3 mg

Phenylephrine HCI is a sympathomimetic amine with the chemical structure: Benzenemethanol, 3- hydroxy-(- [(methylamino)methyl]- hydrochloride.

C9H13NO2 • HCI                   M.W. 203.67

Dexchlorpheniramine Maleate is an antihistamine with the chemical structure: (+)-2-[p-Chloro-(- [2-(dimethylamino) ethyl]benzyl] pyridine maleate (1:1)

C16H19CIN2 • C4H4O4             M.W. 390.86

INACTIVE INGREDIENTS

calcium phosphate dibasic, D&C Yellow #10, magnesium stearate (veg.), methylcellulose, povidone, and silicified microcrystalline cellulose.

CLINICAL PHARMACOLOGY

Phenylephrine Hydrochloride is a sympathomimetic amine, which acts directly on (-adrenergic receptors in the mucosa of the respiratory tract to produce vasoconstriction that increases peripheral resistance, resulting in an increase in both systolic and diastolic blood pressure. Accompanying the pressor response is a marked reflex bradycardia due to increased vagal activity. It produces vasoconstriction that lasts longer than that produced by ephedrine and epinephrine, and in therapeutic doses, produces little or no central nervous system (CNS) stimulation. Phenylephrine has reduced bioavailability from the gastrointestinal tract because of first pass metabolism by monoamine oxidase in the stomach and liver.

Dexchlorpheniramine Maleate is the dextro-isomer of the racemic compound chlorpheniramine maleate. In vitro and in vivo assays of the antihistamine potencies of the optically active isomers of chlorpheniramine demonstrate that the predominant activity is in the dextro-isomer. The dextro-isomer is approximately two times more active than the racemic compound. Dexchlorpheniramine maleate competitively antagonizes most of the smooth muscle stimulating actions of histamine on the H1 receptors of the GI tract, uterus, large blood vessels, and bronchial muscle. It also antagonizes the action of histamine that results in increased capillary permeability and the formation of edema. Dexchlorpheniramine maleate is an alkylamine-type antihistamine. This group of antihistamines is among the most active histamine antagonists and are generally effective in relatively low doses. They thereby prevent, but do not reverse, responses mediated by histamine alone. The anticholinergic actions of most antihistamines provide a drying effect on the nasal mucosa. These drugs are not so prone to produce drowsiness and are among the most suitable agents for daytime use, but a significant proportion of patients do experience this effect.

INDICATIONS AND USAGE

This product provides relief of the symptoms resulting from irritation of sinus, nasal, and upper respiratory tract tissue. Phenylephrine exerts a vasoconstrictive and decongestive action while dexchlorpheniramine maleate decreases the symptoms of watering eyes, post-nasal drip, and sneezing.

CONTRAINDICATIONS

This product is contraindicated in women who are pregnant or nursing. This product is contraindicated in children under six years of age because this age group is sensitive to the effects of sympathomimetic amines. It is also contraindicated in newborn or premature infants because this age group has an increased susceptibility to the anticholinergic side effects of dexchlorpheniramine maleate. Geriatric patients may be more sensitive to the effects of this medication. Risk-benefit should be considered when the following conditions exist:

Sensitivity to phenylephrine or dexchlorpheniramine; Acute asthma; Bladder neck obstruction; Brain damage in children; Cardiac disease, especially cardiac arrhythmias, congestive heart failure, coronary artery disease, and mitralstenosis; Cardiovascular disease; Diabetes mellitus; Down’s Syndrome; Esophagitis, reflux; Glaucoma; Acute hemorrhage with unstable cardiovascular status; Hepatic function impairment; Hernia; Hypertension; Hyperthyroidism; Intestinal atony in the elderly or debilitated patient; Chronic lung disease; Myasthenia gravis; Autonomic neuropathy; Paralytic ileus; Prostatic hypertrophy; Psychiatric disorders; Pyloric obstruction; Renal function impairment; Spastic paralysis, in children; Tachycardia; Toxemia of pregnancy; Ulcerative colitis; Urinary retention, or predisposition to; Uropathy; Xerostomia.

WARNINGS

This product may cause drowsiness or blurred vision. Patients taking this product should be warned not to engage in activities requiring mental alertness such as operating a motor vehicle or other machinery or to perform hazardous tasks while taking this drug. Sympathomimetic amines should be used with caution in patients with hypertension, ischemic heart disease, diabetes mellitus, increased intraocular pressure, hyperthyroidism, or prostatic hypertrophy. Sympathomimetic amines in overdosage may produce CNS stimulation with convulsions or cardiovascular collapse with accompanying hypotension. Do not exceed recommended dosage. Antihistamines should be used with considerable caution in pyloroduodenal obstruction; symptomatic prostatic hypertrophy; bladder neck obstruction. Antihistamines may cause excitability, especially in children. At dosages higher than the recommended dose, nervousness, dizziness or sleeplessness may occur. Do not exceed recommended dosage.

PRECAUTIONS

General

Use phenylephrine with caution in patients with hypoxia, acidosis, or a history of arteriosclerosis, bradycardia, partial heart block, hypertension, myocardial disease, thrombosis, or ventricular tachycardia. Antihistamines have an atropine-like action and should be used with caution in patients with a history of bronchial asthma, emphysema, increased intraocular pressure, hyperthyroidism, cardiovascular disease and hypertension.

Information for Patients

Patient consultation should include the following information regarding proper use of this medication:

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Do not take more medication than the amount recommended.

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May be taken with or without food; can be taken with food, a glass of water or milk to lessen stomach irritation if necessary.

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Do not drive or operate machinery if drowsiness or dizziness occurs.

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Do not ingest alcoholic beverages, monoamine oxidase (MAO) inhibitors, or CNS depression producing medications (hypnotics, sedatives, tranquilizers) while taking this medication.

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This medication possibly increases sensitivity of eyes to light.

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If a dose is missed, the medication should be taken as soon as possible unless it is almost time for the next dose: not doubling doses.

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This medication should be stored in a tight, light-resistant container at temperatures between 20°- 25°C (68°-77°F), see USP Controlled Room Temperature. Avoid exposure to heat.

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Keep all medications out of the reach of children. In case of accidental overdose, seek professional assistance or contact a poison control center immediately.

Caution patients about the signs of potential side effects, especially:

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Anticholinergic effects – clumsiness or unsteadiness; severe drowsiness; severe dryness of mouth, nose, or throat; flushing or redness of face; shortness of breath or troubled breathing.

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Blood dyscrasias - sore throat and fever; unusual bleeding or bruising; unusual tiredness or weakness.

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Fast or irregular heartbeat.

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Psychotic episodes.

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Tightness in chest.

Laboratory Tests

The following may be especially important in patient monitoring (other tests may be warranted in some patients, depending on conditions): Blood pressure determination– recommended at frequent intervals during therapy; Electrocardiogram (ECG) – monitoring may be required; Intraocular pressure determination - recommended at periodic intervals, as these medications may increase the intraocular pressure.

Drug Interactions

Do not take this product if you are presently taking, or have taken within the preceding two weeks, a prescription drug for high blood pressure without first consulting your physician. Combinations containing any of the following medications, depending on the amount present, may also interact with this product:

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(-adrenergic blocking agents or other medications with (-adrenergic blocking action -prior administration of (-adrenergics may block the pressor response to phenylephrine, possibly resulting in severe hypotension; medications with (-adrenergic blocking action may decrease the pressor effect and shorten the duration of action of phenylephrine.

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Anesthetics, hydrocarbon inhalation- Concurrent use of chloroform, cyclopropane, halothane, or trichloroethylene with phenylephrine may increase the risk of severe ventricular arrhythmias because these anesthetics greatly sensitize the myocardium to the effects of sympathomimetic amines; phenylephrine should be used with caution and in substantially reduced dosage in patients receiving these anesthetics. Enflurane, isoflurane, or methoxyflurane may also cause some sensitization of the myocardium to the effects of sympathomimetic amines.

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Anesthetics, parenteral-local - Phenylephrine should be used cautiously and in carefully circumscribed quantities, if at all, with local anesthetics for anesthetizing areas with end arteries (such as the fingers, toes, or penis) or otherwise compromised blood supply; ischemia leading to gangrene may result.

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Anticholinergics - Concurrent use with anticholinergics may intensify anticholinergic effects; patients should be advised to report occurrence of gastrointestinal problems promptly since paralytic ileus may occur with concurrent therapy.

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Antidepressants, tricyclic or maprotiline - Concurrent use may potentiate the cardiovascular effects of phenylephrine, possibly resulting in arrhythmias, tachycardia, or severe hypertension or hyperpyrexia.

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Antihypertensives, or diuretics used as - Antihypertensive effects may be reduced when these medications are used concurrently with phenylephrine; the patient should be carefully monitored to confirm that the desired effect is being obtained.

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(-adrenergic blocking agents - Therapeutic effects may be inhibited when these medications are used concurrently with phenylephrine, especially larger doses; also, (-adrenergic blockade may result in unopposed (-adrenergic activity with a risk of hypertension and excessive bradycardia with possible heart block.

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CNS Depressants – Concurrent use of antihistamines with alcohol, tricyclic antidepressants, barbiturates and other CNS depressants may have an additive effect.

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Cocaine, mucosal-local - Concurrent use with phenylephrine may increase the cardiovascular effects of either or both medications and the risk of adverse side effects.

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Digitalis glycosides – Concurrent use with phenylephrine may increase the risk of cardiac arrhythmias; caution and ECG monitoring are necessary if concurrent use is required.

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Ergoloid mesylates or Ergotamine - Concurrent ergoloid mesylates or ergotamine with phenylephrine may produce peripheral vascular ischemia and gangrene and is not recommended. Concurrent use of ergotamine with phenylephrine may potentiate the pressor effect of phenylephrine, resulting in possible severe hypertension and rupture of cerebral blood vessels.

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Doxapram - Concurrent use may increase the pressor effects of either doxapram or phenylephrine.

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Ketoconazole – Anticholinergics may increase gastrointestinal pH, possibly resulting in a marked reduction in ketoconazole absorption during concurrent use with anticholinergics; patients should be advised to take these medications at least 2hours after ketoconazole.

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Methyldopa - In addition to possibly decreasing the hypotensive effects of these medications, concurrent use may enhance the pressor response to phenylephrine; caution is required with very small initial doses of methyldopa being administered.

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MAO inhibitors – Concurrent use may prolong and intensify cardiac stimulant and vasopressor effects of phenylephrine and dexchlorpheniramine, resulting in headache, cardiac arrhythmias, vomiting or sudden and severe hypertensive and/or hyperpyretic crises. These medications should not be administered during or within 14 days following the administration of MAO inhibitor therapy.

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Potassium chloride – Concurrent use with anticholinergics may increase the severity of potassium chloride-induced gastrointestinal lesions.

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Rauwolfia alkaloids – Concurrent use may prolong the direct-acting sympathomimetic amines by preventing the uptake into storage granules.

DRUG & OR LABORATORY TEST INTERACTIONS

Antihistamines may interfere with diagnostic test results for skin tests using allergen extracts. Anticholinergics may interfere with diagnostic test results for gastric acid secretion by antagonizing the effect of pentagastrin and histamine, and for radio nucleotide gastric emptying studies by delaying gastric emptying.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No data are available on the long term potential of the components of this product for carcinogenesis, mutagenesis or impairment of fertility in animals or humans.

Pregnancy

Pregnancy: Category C: Reproduction studies have been performed with chlorpheniramine maleate. Studies in rabbits and rats at doses up to 50 times and 85 times the human dose revealed no evidence of harm to the fetus. There are, however, no adequate and well controlled studies in pregnant women. Therefore, it is not known whether these drugs can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Animal reproduction studies have not been conducted with phenylephrine. This product should be given to a pregnant woman only if clearly needed.

Labor and Delivery

Use of phenylephrine during labor may cause fetal anoxia and bradycardia by increasing contractility of the uterus and decreasing uterine blood flow.

Nursing Mothers

Small amounts of sympathomimetic amines and antihistamines are excreted in breast milk; use is not recommended because of the risk of adverse effects, such as unusual excitement or irritability, in infants. Anticholinergics and antihistamines may inhibit lactation.

Pediatric Use

Use of antihistamines is not recommended in newborn or premature infants because this age group has an increased susceptibility to anticholinergic side effects, such as CNS excitation, and an increased tendency toward convulsion. In infants and children, overdosage may cause hallucinations, convulsions, and death. A paradoxical reaction characterized by hyperexcitability may occur in older children taking antihistamines. Use is not recommended for children under six years of age. Appropriate studies with phenylephrine have not been performed in the pediatric population; however, no pediatric specific problems have been documented to date.

Geriatric Use

Confusion, hallucinations, seizures and CNS depression may be more likely to occur in geriatric patients taking sympathomimetic amines. Geriatric patients also may be more sensitive to the effects, especially the vasopressor effects, of sympathomimetic amines. Confusion, dizziness, sedation, hypotension, hyperexcitability, and anticholinergic side effects, such as dryness of mouth and urinary retention (especially in males), may be more likely to occur in geriatric patients taking antihistamines. Geriatric patients may respond to usual doses of anticholinergics with excitement, agitation, drowsiness, or confusion. Geriatric patients are especially susceptible to the anticholinergic side effects, such as constipation, dryness of mouth, and urinary retention (especially in males). If these side effects occur and continue or are severe, medication should probably be discontinued. Caution is also recommended when anticholinergics are given to geriatric patients, because of the danger of precipitating undiagnosed glaucoma. Memory may become severely impaired in geriatric patients, especially those who already have memory problems, with the continued use of anticholinergics, since these drugs block the action of acetylcholine, which is responsible for many functions of the brain, including memory function.

ADVERSE REACTIONS

The following adverse reactions have been observed with the use of phenylephrine and dexchlorpheniramine: Arrhythmias, blood dyscrasias, CNS depression, CNS stimulation, dizziness, drowsiness, dryness of mouth, hallucinations, hypotension, hypertension, increased sensitivity of skin to sun, increased sweating, loss of appetite, paradoxical reaction, restlessness, skin rash, stomach upset or pain, thickening of mucus, tingling in hands or feet, trembling, troubled breathing, unusual tiredness or weakness, vomiting.

Note: Agitation; confusion; difficult or painful urination; drowsiness; dizziness; and dryness of mouth, nose or throat are more likely to occur in the elderly. Nightmares, unusual excitement, nervousness, restlessness, or irritability are more likely to occur in children and the elderly.

DRUG ABUSE AND DEPENDENCE

Central nervous system stimulants such as phenylephrine have been abused. At high doses, subjects commonly experience an elevation of mood, a sense of increased energy and alertness, and decreased appetite. Some individuals become anxious, irritable and loquacious. In addition to the marked euphoria, the user experiences a sense of markedly enhanced physical strength and mental capacity. With continued use, tolerance develops, the user increases the dose, and toxic signs and symptoms appear. Depression may follow rapid withdrawal. Stimulants, such as phenylephrine, are banned and tested for by the US Olympic Committee (USOC) and the National Collegiate Athletic Association (NCAA).

OVERDOSAGE

This product is comprised of pharmacologically different components (sympathomimetic amine, and antihistamine). Therefore, it is difficult to predict the exact manifestation of symptoms in a given individual. Reaction to an overdose of this product may vary from CNS depression to stimulation. A description of symptoms which are likely to appear after ingestion of an excess of the individual components follows:

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Overdosage with sympathomimetic amines can cause cardiac arrhythmias, cerebral hemorrhage and pulmonary edema. It can also cause palpitations, tremor, dizziness, vomiting, fear, labored breathing, headache, dryness of mouth, pallor, weakness, panic, anxiety, confusion, and hallucination.

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Manifestation of antihistamine overdosage may vary from CNS depression to stimulation. Other signs and symptoms may be dizziness, tinnitus, ataxia, blurred vision, and hypotension. Stimulation is particularly likely in children as are atropine-like signs and symptoms (dry mouth, fixed, dilated pupils, flushing, hyperthermia, and gastrointestinal symptoms). In infants and children particularly, antihistamines, in overdosage may produce convulsion and/or death.

Treatment of acute overdosage would probably be based upon treating the patient for phenylephrine toxicity which may manifest itself as excessive CNS stimulation resulting in excitement, tremor, restlessness, and insomnia. Other effects may include hyperpyrexia, hypertension, mydriasis, hyperglycemia and urinary retention. Severe overdosage may cause tachypnea or hyperpnea, convulsions or delirium, but in some individuals there may be CNS depression with somnolence, stupor, or respiratory depression. Arrhythmias may lead to hypotension and circulatory collapse. Severe hypokalemia can occur, probably due to a compartmental shift rather than a depletion of potassium. No organ damage or significant metabolic derangement is associated with overdosage.

General Treatment: Treatment is symptomatic and supportive with possible utilization of the following:

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Induction of emesis (syrup of Ipecac recommended); however, precaution against aspiration is necessary, especially in infants and children.

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Gastric lavage (isotonic or 0.45% sodium chloride solution) if patient is unable to vomit within three hours of ingestion.

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Saline cathartics (milk of magnesia) may be used.

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Vasopressors to treat hypotension; however, epinephrine should not be used since it may further lower blood pressure.

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For excessive hypertensive effect an (-adrenergic blocker, such as phentolamine, may be administered.

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Hyperpyrexia, especially in children, may require treatment by means of external cooling.

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Excessive CNS stimulation may be counteracted with parenteral diazepam.

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Oxygen and intravenous fluids.

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Precaution against the use of stimulants (analeptic agents) is recommended because they may cause seizures.

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Excitement to a degree which demands attention may be managed with sodium thiopental 2% solution given slowly intravenously or chloral hydrate (100 - 200 mL of a 2% solution) by rectal infusion. In severe cases of overdosage it is essential to monitor both the heart (by electrocardiograph) and plasma electrolytes, and to give intravenous potassium as indicated. In the event of progression of the curare-like effect to paralysis of the respiratory muscles or apnea, artificial respiration should be instituted and maintained until effective respiratory action returns.

DOSAGE AND ADMINISTRATION

Adults and adolescents 12 years of age and older: 1 or 2 tablets every 12 hours as directed by a physician.

Children 6 to 12 years of age: 1 tablet every 12 hours as directed by a physician.

Not recommended for children under 6 years of age. Do not crush or chew tablets prior to swallowing.

Note: Geriatric patients may be more sensitive to the effects of the usual adult dose. Adjust adult dose accordingly.

HOW SUPPLIED

Supplied as yellow & white, bilayered, capsule-shaped tablets debossed “RES JR” on one side and scored on the opposite. Available in bottles of 90 tablets, NDC 64543-084-90, and sample packs of 2 tablets, NDC 64543-084-02.

KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, CALL A DOCTOR OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

Storage and Handling

Dispense in tight, light resistant containers as defined in the USP/NF, with child resistant closures. Store at controlled room temperature between 20°- 25°C (68°- 77°F); see USP Controlled Room Temperature. Avoid exposure to heat.

Call Your Doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Manufactured for:

Capellon Pharmaceuticals, LLC

Fort Worth, TX 76118

Rev. 06/2009

500390

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Figure 1: 90 ct. Label

Figure 2: Blister label

Rescon JR  phenylephrine hydrochloride / dexchlorpheniramine maleate  tablet, multilayer, extended release

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 64543-084 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 20 mg DEXCHLORPHENIRAMINE MALEATE (DEXCHLORPHENIRAMINE) DEXCHLORPHENIRAMINE MALEATE 3 mg

Inactive Ingredients Ingredient Name Strength DIBASIC CALCIUM PHOSPHATE DIHYDRATE   D&C YELLOW NO. 10   MAGNESIUM STEARATE   HYPROMELLOSE 2208 (4000 MPA.S)   POVIDONE K30   CELLULOSE, MICROCRYSTALLINE   SILICON DIOXIDE

Product Characteristics Color YELLOW, WHITE Score 2 pieces Shape CAPSULE Size 15mm Flavor Imprint Code RES;JR Contains

Packaging # NDC Package Description Multilevel Packaging 1 64543-084-90 90 TABLET In 1 BOTTLE None 2 64543-084-02 2 TABLET In 1 BLISTER PACK None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		01/21/2010	04/30/2012

Labeler - Capellon Pharmaceuticals, LLC (124568093)

Registrant - Capellon Pharmaceuticals, LLC (124568093)

Establishment
Name	Address	ID/FEI	Operations
Sovereign Pharmaceuticals, LLC		623168267	MANUFACTURE

Revised: 01/2010Capellon Pharmaceuticals, LLC