BROMPHENIRAMINE: 41 Adverse Event Reports & Safety Profile

DESCRIPTION Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide Syrup is a light pink colored, clear syrup with a grape flavor.

Each

5 mL (1 teaspoonful) contains: Brompheniramine Maleate, USP.......................................2 mg Pseudoephedrine Hydrochloride, USP.............................30 mg Dextromethorphan Hydrobromide, USP...........................10 mg Alcohol 0.95% v/v In a palatable, aromatic vehicle.

Inactive

Ingredients: sucrose, glycerin, ethyl alcohol, propylene glycol, methylparaben, citric acid, sodium citrate dihydrate, sodium benzoate, FD&C Red No. 40, and artificial grape flavor. It may contain 10% citric acid solution or 10% sodium citrate solution for pH adjustment. The pH range is between 3.0 and 6.0. C 16 H 19 BrN 2

• C 4 H 4 O 4 M.W.

435.31 Brompheniramine Maleate, USP(±)-2- p-Bromo-α-2-(dimethylamino)ethylbenzylpyridine maleate (1:1) C 10 H 15 NO•HCl M.W.

201.69 Pseudoephedrine Hydrochloride, USP (+)-Pseudoephedrine hydrochloride C 18 H 25 NO•HBr•H 2 O M.W.

370.32 Dextromethorphan Hydrobromide, USP 3-Methoxy-17-methyl-9α, 13α, 14α- morphinan hydrobromide monohydrate Antihistamine/Nasal Decongestant/Antitussive syrup for oral administration. "Image Description" "Image Description" "Image Description"

Indication and usage section Indication and usage section Do not exceed more than 6 dosesin a 24-hour period Shake before use measure only with dosing cup provided keep dosing cup with product ml=milliliters TSP=teaspoonful This adult product is no intented for use in children under 12 years of age Adult and children 12 years of age and over 5ml (1 teaspoonful) every 4 hours children under 12 years of age Do not use indication an user

Dosage & Administration section Dosage & Administration section Do not exceed more than 6 dosesin a 24-hour period Shake before use measure only with dosing cup provided keep dosing cup with product ml=milliliters TSP=teaspoonful This adult product is no intented for use in children under 12 years of age Adult and children 12 years of age and over 5ml (1 teaspoonful) every 4 hours children under 12 years of age Do not use dosage

CONTRAINDICATIONS Hypersensitivity to any of the ingredients. Do not use in the newborn, in premature infants, in nursing mothers, or in patients with severe hypertension or severe coronary artery disease. Do not use dextromethorphan in patients receiving monoamine oxidase (MAOI) inhibitors ( see PRECAUTIONS – Drug Interactions ). Antihistamines should not be used to treat lower respiratory tract conditions including asthma.

ADVERSE REACTIONS The most frequent adverse reactions to brompheniramine maleate, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide syrup are: sedation; dryness of mouth, nose and throat; thickening of bronchial secretions; dizziness. Other adverse reactions may include: Dermatologic: Urticaria, drug rash, photosensitivity, pruritus.

Cardiovascular

System: Hypotension, hypertension, cardiac arrhythmias, palpitation. CNS: Disturbed coordination, tremor, irritability, insomnia, visual disturbances, weakness, nervousness, convulsions, headache, euphoria, and dysphoria. G.U. System: Urinary frequency, difficult urination. G.I. System: Epigastric discomfort, anorexia, nausea, vomiting, diarrhea, constipation.

Respiratory

System: Tightness of chest and wheezing, shortness of breath.

Hematologic

System: Hemolytic anemia, thrombocytopenia, agranulocytosis.

Respiratory

System: Tightness of chest and wheezing, shortness of breath.

Hematologic

System: Hemolytic anemia, thrombocytopenia, agranulocytosis. To report SUSPECTED ADVERSE REACTIONS, contact PAI Pharma at 1-800-845-8210 or FDA at 1-800-FDA-1088 or HYPERLINK "http://www.fda.gov/medwatch" www.fda.gov/medwatch.

Warnings: Do not use

• in a child under 2 years of age
• if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have:
• heart disease
• high blood pressure
• thyroid disease
• diabetes
• glaucoma
• cough that occurs with too much phlegm (mucus)
• trouble urinating due to an enlarged prostate gland
• a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema. Do not give this product to children who have breathing problems such as chronic bronchitis or who have glaucoma without first consulting the child's doctor. Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. While using this product:
• do not exceed recommended dosage
• excitability may occur especially in children
• drowsiness may occur; alcohol, sedatives and tranquilizers may increase the drowsiness effect. Avoid alcoholic beverages while taking this product. Use caution when driving a motor vehicle or operating machinery. Stop use and ask a doctor if:
• if you get nervous, dizzy or sleepless
• new symptoms occur
• symptoms do not get better within 7 days or are accompanied by fever
• cough lasts more than 7 days, comes back, or is accompanied by fever, rash or persistent headache. These could be signs of serious conditions. If pregnant or breast-feeding ask a health professional before use. KEEP OUT OF REACH OF CHILDREN . In case of overdose, get medical help or contact a Poison Control Center right away.

PRECAUTIONS General Because of its antihistamine component, Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide Oral Syrup should be used with caution in patients with a history of bronchial asthma, narrow angle glaucoma, gastrointestinal obstruction, or urinary bladder neck obstruction. Because of its sympathomimetic component, Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide Oral Syrup should be used with caution in patients with diabetes, hypertension, heart disease, or thyroid disease. Information for Patients Patients should be warned about engaging in activities requiring mental alertness, such as driving a car or operating dangerous machinery. Repackaged By / Distributed By: RemedyRepack Inc. 625 Kolter Drive, Indiana, PA 15701 (724) 465-8762 Drug Interactions Monoamine oxidase (MAO) inhibitors Hyperpyrexia, hypotension, and death have been reported coincident with the coadministration of MAO inhibitors and products containing dextromethorphan. In addition, MAO inhibitors prolong and intensify the anticholinergic (drying) effects of antihistamines and may enhance the effect of pseudoephedrine. Concomitant administration of Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide Oral Syrup and MAO inhibitors should be avoided ( see CONTRAINDICATIONS ).

Central Nervous

System (CNS) depressants Antihistamines have additive effects with alcohol and other CNS depressants (hypnotics, sedatives, tranquilizers, antianxiety agents, etc.). Antihypertensive drugs Sympathomimetic may reduce the effects of antihypertensive drugs. Carcinogenesis, Mutagenesis, Impairment of Fertility Animal studies of Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide Oral Syrup to assess the carcinogenic and mutagenic potential or the effect on fertility have not been performed.

Pregnancy Teratogenic Effects Pregnancy

Category C Animal reproduction studies have not been conducted with Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide Oral Syrup. It is also not known whether Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide Oral Syrup can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. It should be given to a pregnant woman only if clearly needed. Reproduction studies of brompheniramine maleate (a component of Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide Oral Syrup) in rats and mice at doses up to 16 times the maximum human doses have revealed no evidence of impaired fertility or harm to the fetus.

Nursing Mothers

Because of the higher risk of intolerance of antihistamines in small infants generally, and in newborns and prematures in particular, Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide Oral Syrup is contraindicated in nursing mothers.

Pediatric Use

Safety and effectiveness in pediatric patients below the age of 6 months have not been established ( see DOSAGE AND ADMINISTRATION ).

Geriatric Use

Clinical studies of Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide Oral Syrup did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. However, antihistamines are more likely to cause dizziness, sedation, and hypotension in elderly patients. The elderly are also more likely to experience adverse reactions to sympathomimetics. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Drug Interactions Monoamine oxidase (MAO) inhibitors Hyperpyrexia, hypotension, and death have been reported coincident with the coadministration of MAO inhibitors and products containing dextromethorphan. In addition, MAO inhibitors prolong and intensify the anticholinergic (drying) effects of antihistamines and may enhance the effect of pseudoephedrine. Concomitant administration of Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide Syrup and MAO inhibitors should be avoided (see CONTRAINDICATIONS ). Central nervous system (CNS) depressants Antihistamines have additive effects with alcohol and other CNS depressants (hypnotics, sedatives, tranquilizers, antianxiety agents, etc.). Antihypertensive drugs Sympathomimetic may reduce the effects of antihypertensive drugs. Carcinogenesis, Mutagenesis, Impairment of Fertility Animal studies of Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide Syrup to assess the carcinogenic and mutagenic potential or the effect on fertility have not been performed.

Pregnancy Teratogenic Effects

Animal reproduction studies have not been conducted with Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide Syrup. It is also not known whether Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide Syrup can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. It should be given to a pregnant woman only if clearly needed. Reproduction studies of brompheniramine maleate (a component of Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide Syrup) in rats and mice at doses up to 16 times the maximum human doses have revealed no evidence of impaired fertility or harm to the fetus.

Nursing Mothers

Because of the higher risk of intolerance of antihistamines in small infants generally, and in newborns and prematures in particular, Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide Syrup is contraindicated in nursing mothers.

Pediatric Use

Safety and effectiveness in pediatric patients below the age of 6 months have not been established (see DOSAGE AND ADMINISTRATION ).

Geriatric Use

Clinical studies of Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide Syrup did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. However, antihistamines are more likely to cause dizziness, sedation, and hypotension in elderly patients. The elderly are also more likely to experience adverse reactions to sympathomimetics. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Active ingredients (in each 5 mls tsp.)

Purpose

Dextromethorphan HBr 10 mg ...........................

Cough Suppressant Brompheniramine Maleate

4 mg .................................

Antihistaminic

Phenylephrine HCl 10 mg .................................

Nasal

Decongestant

Ivactives ingredient section Ivactives ingredient section Blue cohosh root extract, echinacea root extract, eucalyptus oil, ginkgo biloba leaf extract, glycerin, goldenseal root extract, honey, horehound(flower, leaft, stem) extract, licorice root extract, menthol, methylparaben, mullein leaf extract, myrrh gum extract, potassium sorbate, propylene glycol, propylparaben, slippery eilm bark extract, sodium chloride, sucralose, water, wild cherry bark extract and zinc sulfate. inactive