Label:
BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE- brompheniramine maleate, pseudoep...
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  • NDC Code(s): 42192-630-04, 42192-630-16
  • Packager: Acella Pharmaceuticals, LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated January 31, 2025

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  • SPL UNCLASSIFIED SECTION
    Rx only
  • DESCRIPTION
    Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide Syrup is a clear, colorless, sugar free syrup. Each 5 mL (1 teaspoonful) contains: Brompheniramine ...
  • CLINICAL PHARMACOLOGY
    Brompheniramine maleate is a histamine antagonist, specifically an H - 1-receptor-blocking agent belonging to the alkylamine class of antihistamines. Antihistamines appear to compete with ...
  • INDICATIONS AND USAGE
    Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide Syrup is indicated for relief of coughs and upper respiratory symptoms, including nasal congestion ...
  • 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 ...
  • 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 ...
  • PRECAUTIONS
    General: Because of its antihistamine component, Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide Syrup should be used with caution in patients with a ...
  • 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 ...
  • 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 ...
  • 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 ...
  • 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 ...
  • SPL UNCLASSIFIED SECTION
    Rx Only - Distributed by: Acella Pharmaceuticals, LLC - Alpharetta, GA 30005 - 1-800-541-4802 - L-0444 Rev 1224-01 - 500555-01
  • PRINCIPAL DISPLAY PANEL
    ACELLA Pharmaceuticals LLC - NDC 42192-630-04 - Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide Syrup - DO NOT USE IF INNER FOIL SEAL IS ...
  • PRINCIPAL DISPLAY PANEL
    ACELLA Pharmaceuticals LLC - NDC 42192-630-16 - Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide Syrup - DO NOT USE IF INNER FOIL SEAL IS ...
  • INGREDIENTS AND APPEARANCE
    Product Information