Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide

Clinical summary

Indications and usage 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 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 (½ 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. Warnings and cautions WARNINGS Especially in infants and small children, antihistamines in overdosage may cause hallucinations, convulsions, and death. Antihistamines may diminish mental alertness. In the young child, they may produce excitation. Drug interactions 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. Pregnancy Pregnancy: Teratogenic Effects- Pregnancy Category C: 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.