Country: United States
Language: English
Source: NLM (National Library of Medicine)
BROMPHENIRAMINE MALEATE (UNII: IXA7C9ZN03) (BROMPHENIRAMINE - UNII:H57G17P2FN), PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F), DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)
Proficient Rx LP
ORAL
PRESCRIPTION DRUG
For relief of coughs and upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold. 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 PRECAUTIONS - Drug Interactions ). Antihistamines should not be used to treat lower respiratory tract conditions including asthma.
Brompheniramine maleate, pseudoephedrine hydrochloride and dextromethorphan hydrobromide syrup is a clear, light pink-colored, butterscotch-flavored syrup containing in each 5 mL (1 teaspoonful) brompheniramine maleate 2 mg, pseudoephedrine hydrochloride 30 mg and dextromethorphan hydrobromide 10 mg, available in containers of 4 fluid ounces, NDC 71205-346-04
Abbreviated New Drug Application
BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE- BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP PROFICIENT RX LP ---------- DESCRIPTION Brompheniramine maleate, pseudoephedrine hydrochloride and dextromethorphan hydrobromide syrup is a clear, light pink syrup with a butterscotch flavor. EACH 5 ML (1 TEASPOONFUL) CONTAINS: Brompheniramine Maleate, USP . . . . . . . . 2 mg Pseudoephedrine Hydrochloride, USP . . . . . 30 mg Dextromethorphan Hydrobromide, USP . . . 10 mg Alcohol 0.95% v/v In a palatable, aromatic vehicle. Inactive Ingredients: citric acid anhydrous, dehydrated alcohol, FD&C Red No. 40, glycerin, methylparaben, propylene glycol, purified water, sodium benzoate, and sucrose with butterscotch flavor. It may contain sodium citrate for pH adjustment. The pH range is between 4.0 and 6.0. C H BrN •C H O M.W. 435.31 BROMPHENIRAMINEMALEATE, USP (±)-2- _P_-BROMO-Α-2-(DIMETHYLAMINO)ETHYLBENZYLPYRIDINEMALEATE (1:1) C H NO•HCl 16 19 2 4 4 4 10 15 M.W. 201.69 PSEUDOEPHEDRINE HYDROCHLORIDE, USP (+)-PSEUDOEPHEDRINE HYDROCHLORIDE C H NO•HBr•H O M.W. 370.32 DEXTROMETHORPHANHYDROBROMIDE, USP 3-METHOXY-17-METHYL-9Α, 13Α, 14Α -MORPHINANHYDROBROMIDE MONOHYDRATE Antihistamine/Nasal Decongestant/Antitussive syrup for oral administration. CLINICAL PHARMACOLOGY Brompheniramine maleate is a histamine antagonist, specifically an H -receptor-blocking agent belonging to the alkylamine class of antihistamines. Antihistamines appear to compete with histamine for receptor sites on effector cells. Brompheniramine also has anticholinergic (drying) and sedative effects. Among the antihistaminic effects, it antagonizes the allergic response (vasodilation, increased vascular permeability, increased mucus secretion) of nasal tissue. Brompheniramine is well absorbed from the gastrointestinal tract, with peak plasma concentration after single, oral dose of 4 mg reached in 5 hours; urinary excretion is the major route of elimination, mostly Read the complete document