BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE- brompheniramine maleate, pseudoephedr

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

Bryant Ranch Prepack

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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.

Resumen del producto:

NDC: 63629-2085-1: 473 Syrups in a BOTTLE, PLASTIC

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND
DEXTROMETHORPHAN HYDROBROMIDE- BROMPHENIRAMINE MALEATE,
PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP
BRYANT RANCH PREPACK
----------
BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND
DEXTROMETHORPHAN HYDROBROMIDE SYRUP
2 MG, 30 MG, 10 MG/ 5 ML
RX ONLY
DESCRIPTION
Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and
Dextromethorphan
Hydrobromide Syrup is a clear, light pink syrup with a grape 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, anhydrous citric acid, FD&C Red No. 40,
glycerin,
methylparaben, propylene glycol, sodium benzoate, sucrose, trisodium
citrate dihydrate,
water and artificial grape flavor. 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.
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
PSEUDOEPHEDRINE HYDROCHLORIDE, USP (+)-PSEUDOEPHEDRINE HYDROCHLORIDE
16
19
2
4
4
4
10
15
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
H1-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
abso