BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE syrup

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BROMPHENIRAMINE MALEATE (UNII: IXA7C9ZN03) (BROMPHENIRAMINE - UNII:H57G17P2FN), PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F), DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)

Available from:

Proficient Rx LP

INN (International Name):

BROMPHENIRAMINE MALEATE

Composition:

BROMPHENIRAMINE MALEATE 2 mg in 5 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 Drug Interactions ). Antihistamines should not be used to treat lower respiratory tract conditions including asthma.

Product summary:

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 the following sizes: 4 fl oz (118 mL): NDC 63187-664-04

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND
DEXTROMETHORPHAN HYDROBROMIDE- BROMPHENIRAMINE MALEATE,
PSEUDOEPHEDRINE
HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP
PROFICIENT RX LP
----------
BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND
DEXTROMETHORPHAN
HYDROBROMIDE SYRUP
RX ONLY
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: alcohol, artificial butterscotch flavor, citric
acid anhydrous, glycerin,
methylparaben, propylene glycol, purified water, sodium benzoate,
sodium citrate, sucrose, and FD&C
Red No. 40. It may contain 10% citric acid solution or 10% sodium
citrate solution for pH adjustment.
The pH range is between 3.0 and 6.0.
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
as products of biodegradation; the
liver is assumed to be the main site of metabolic transformation.
Pseudoephedrine acts on sympathetic nerve endings and also on smooth
muscle, making it useful as a
nasal decongestant.