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Brompheniramine Maleate, Pseudoephedrine Hydrochloride and DextromethorphanHydrobromide

Generic: Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide

Verified·Apr 23, 2026
Manufacturer
Wockhardt
NDC
63187-400
RxCUI
1357010
Route
ORAL
ICD-10 indication
J30.9

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About Brompheniramine Maleate, Pseudoephedrine Hydrochloride and DextromethorphanHydrobromide

What is this medication? Brompheniramine maleate, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide is a combination medication used to provide temporary relief from symptoms caused by the common cold, hay fever, or other upper respiratory allergies. This pharmaceutical preparation targets multiple issues simultaneously, such as nasal congestion, sinus pressure, and a persistent cough. It is frequently prescribed or recommended to help manage the discomfort associated with seasonal allergies and the flu by addressing both respiratory and sinus-related distress.

The three active ingredients in this medication work through different mechanisms to alleviate physical symptoms. Brompheniramine maleate is an antihistamine that reduces sneezing, runny nose, and watery eyes, while pseudoephedrine hydrochloride acts as a decongestant to shrink swollen membranes in the nasal passages. Dextromethorphan hydrobromide functions as a cough suppressant by affecting the cough reflex in the brain. Together, these components help clear the airways and reduce the urge to cough, allowing for improved breathing and rest during recovery.

Copay & patient assistance

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Prescribing information

From the FDA-approved label for Brompheniramine Maleate, Pseudoephedrine Hydrochloride and DextromethorphanHydrobromide. Official source: DailyMed (NLM) · Label effective May 1, 2020

Indications and usage
INDICATIONS AND USAGE 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.
Contraindications
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 Drug Interactions ). Antihistamines should not be used to treat lower respiratory tract conditions including asthma.
Warnings
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 (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.
Adverse reactions
ADVERSE REACTIONS The most frequent adverse reactions to Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide Oral 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.
Use in pregnancy
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.

Label text is reproduced as-is from the FDA-approved label. We do not paraphrase, summarize, or omit. Content above is for informational purposes only and is not medical advice. Always consult your prescribing clinician or pharmacist before making decisions about your medication.

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How this page is sourced

  • Drug identity verified against openFDA NDC Directory.
  • Label text (when shown) originates from NLM DailyMed.
  • Copay and assistance URLs verified periodically; if you hit a broken link, tell us.