Label: BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE- brompheniramine maleate, pseudoep...view full title
- 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 SECTIONRx only
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DESCRIPTIONBrompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide Syrup is a clear, colorless, sugar free syrup. Each 5 mL (1 teaspoonful) contains: Brompheniramine ...
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CLINICAL PHARMACOLOGYBrompheniramine maleate is a histamine antagonist, specifically an H - 1-receptor-blocking agent belonging to the alkylamine class of antihistamines. Antihistamines appear to compete with ...
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INDICATIONS AND USAGEBrompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide Syrup is indicated for relief of coughs and upper respiratory symptoms, including nasal congestion ...
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CONTRAINDICATIONSHypersensitivity 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 ...
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WARNINGSEspecially 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 ...
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PRECAUTIONSGeneral: Because of its antihistamine component, Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide Syrup should be used with caution in patients with a ...
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ADVERSE REACTIONSThe most frequent adverse reactions to Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide Syrup are: sedation; dryness of mouth, nose and throat; thickening ...
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OVERDOSAGESigns and Symptoms: Central nervous system effects from overdosage of brompheniramine may vary from depression to stimulation, especially in children. Anticholinergic effects may be noted ...
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DOSAGE AND ADMINISTRATIONAdults 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 ...
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HOW SUPPLIEDBrompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide Syrup is a clear, colorless, sugar free syrup. Each 5 mL (1 teaspoonful) contains: brompheniramine maleate ...
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SPL UNCLASSIFIED SECTIONRx Only - Distributed by: Acella Pharmaceuticals, LLC - Alpharetta, GA 30005 - 1-800-541-4802 - L-0444 Rev 1224-01 - 500555-01
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PRINCIPAL DISPLAY PANELACELLA Pharmaceuticals LLC - NDC 42192-630-04 - Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide Syrup - DO NOT USE IF INNER FOIL SEAL IS ...
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PRINCIPAL DISPLAY PANELACELLA Pharmaceuticals LLC - NDC 42192-630-16 - Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide Syrup - DO NOT USE IF INNER FOIL SEAL IS ...
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INGREDIENTS AND APPEARANCEProduct Information