Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide

INDICATIONS AND USAGE Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide Syrup is indicated for relief of coughs and upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold.

DOSAGE AND ADMINISTRATION Adults and pediatric patients 12 years of age and over: 10 mL (2 teaspoonfuls) every 4 hours. Children 6 to under 12 years of age: 5 mL (1 teaspoonful) every 4 hours. Children 2 to under 6 years of age: 2.5 mL (1⁄2 teaspoonful) every 4 hours. Infants 6 months to under 2 years of age: Dosage to be established by a physician. Do not exceed 6 doses during a 24-hour period.

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 inhibitors (MAOIs) (see 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.

Drug Interactions: Monoamine oxidase inhibitors (MAOIs) Hyperpyrexia, hypotension, and death have been reported coincident with the coadministration of MAOIs and products containing dextromethorphan. In addition, MAOIs 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 MAOIs 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.

DESCRIPTION Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide Syrup is a pink, sugar free syrup with a melon flavor. Each 5 mL (1 teaspoonful) contains: Brompheniramine Maleate, USP . . . . . . . . 2 mg Pseudoephedrine Hydrochloride, USP . . . . . 30 mg Dextromethorphan Hydrobromide, USP . . . 10 mg Inactive Ingredients: citric acid anhydrous, FD&C Red No. 40, glycerin, melon flavoring, methylparaben, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, and sucralose. 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. Chemical Structure Chemical Structure Chemical Structure

OVERDOSAGE Signs and Symptoms: Central nervous system effects from overdosage of brompheniramine may vary from depression to stimulation, especially in children. Anticholinergic effects may be noted. Toxic doses of pseudoephedrine may result in CNS stimulation, tachycardia, hypertension, and cardiac arrhythmias; signs of CNS depression may occasionally be seen. Dextromethorphan in toxic doses will cause drowsiness, ataxia, nystagmus, opisthotonos, and convulsive seizures. Toxic Doses: Data suggest that individuals may respond in an unexpected manner to apparently small amounts of a particular drug. A 21⁄2-year-old child survived the ingestion of 21 mg/kg of dextromethorphan exhibiting only ataxia, drowsiness, and fever, but seizures have been reported in 2 children following the ingestion of 13–17 mg/kg. Another 21⁄2-year-old child survived a dose of 300–900 mg of brompheniramine. The toxic dose of pseudoephedrine should be less than that of ephedrine, which is estimated to be 50 mg/kg. Treatment: Induce emesis if patient is alert and is seen prior to 6 hours following ingestion. Precautions against aspiration must be taken, especially in infants and small children. Gastric lavage may be carried out, although in some instances tracheostomy may be necessary prior to lavage. Naloxone hydrochloride 0.005 mg/kg intravenously may be of value in reversing the CNS depression that may occur from an overdose of dextromethorphan. CNS stimulants may counter CNS depression. Should CNS hyperactivity or convulsive seizures occur, intravenous short-acting barbiturates may be indicated. Hypertensive responses and/or tachycardia should be treated appropriately. Oxygen, intravenous fluids, and other supportive measures should be employed as indicated.

HOW SUPPLIED Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide Syrup is a clear, colorless, sugar free syrup. Each 5 mL (1 teaspoonful) contains: brompheniramine maleate 2 mg, pseudoephedrine hydrochloride 30 mg and dextromethorphan hydrobromide 10 mg, and is available in the following sizes: 4 fl oz (118 mL) NDC 85766-250-04 (relabeled from NDC 42192-630-04) 16 fl oz (473 mL) NDC 85766-250-16 (relabeled from NDC 42192-630-16) RECOMMENDED STORAGE Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. KEEP TIGHTLY CLOSED Dispense in a tight, light-resistant container as defined in the USP.