BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE- brompheniramine maleate, pseudoephedrine

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

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide Syrup is indicated 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 inhibitors (MAOIs) (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 pink, sugar free syrup with a melon flavor. Each 5 mL (1 teaspoonful) contains: brompheniramine maleate 2 mg, pseudoephedrine hydrochloride 30 mg and dextromethorphan hydrobromide 10 mg, available in the following sizes: 4 fl oz (118 mL) NDC 63187-930-04 16 fl oz (473 mL) NDC 63187-930-16 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. KEEP TIGHTLY CLOSED Dispense in a tight, light-resistant container as defined in the USP.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE,
DEXTROMETHORPHAN HYDROBROMIDE- BROMPHENIRAMINE MALEATE,
PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP
PROFICIENT RX LP
----------
RX ONLY
DESCRIPTION
Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and
Dextromethorphan
Hydrobromide Syrup is a pink, sugar free syrup with a melon flavor.
EACH 5 ML (1 TEASPOONFUL) CONTAINS:
Brompheniramine Maleate, USP . . . . . . . . 2 mg
Pseudoephedrine Hydrochloride, USP . . . . . 30 mg
Dextromethorphan Hydrobromide, USP . . . 10 mg
INACTIVE INGREDIENTS: citric acid anhydrous, FD&C Red #40, glycerin,
melon flavoring,
methylparaben, propylene glycol, purified water, sodium benzoate,
sodium citrate
dihydrate, and sucralose.
C
H
BrN
•C
H
O
M.W. 435.31
Brompheniramine Maleate, USP
(±)-2- _p_-Bromo-α-2-(dimethylamino)ethylbenzylpyridine maleate
(1:1)
C
H
NO•HCl M.W. 201.69
16
19
2
4
4
4
10
15
Pseudoephedrine Hydrochloride, USP
(+)-Pseudoephedrine hydrochloride
C
H
NO•HBr•H
O M.W. 370.32
Dextromethorphan Hydrobromide, USP
3-Methoxy-17-methyl-9α, 13α, 14α -morphinan hydrobromide
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 as
products of biodegradation; the liver is assumed to be the main site
of metabolic
transformation.
Pseudoephedrine acts on sympathetic