BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE syrup

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

Chartwell RX, LLC

Начин на приложение:

ORAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

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.

Каталог на резюме:

Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide Syrup is a light pink-colored, clear grape-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 62135-302-48 16 fl oz (473 mL)    NDC 62135-302-47 RECOMMENDED STORAGE Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. KEEP TIGHTLY CLOSED Dispense in a tight, light-resistant container as defined in the USP. Manufactured for: Chartwell RX, LLC. Congers, NY 10920 L71079 Revised 01/2023

Статус Оторизация:

Abbreviated New Drug Application

Данни за продукта

BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND
DEXTROMETHORPHAN HYDROBROMIDE- BROMPHENIRAMINE MALEATE,
PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP
CHARTWELL RX, LLC
----------
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 light pink colored, clear 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: sucrose, glycerin, ethyl alcohol, propylene
glycol, methylparaben,
citric acid, sodium citrate dihydrate, sodium benzoate, FD&C Red No.
40, 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
16
19
2
4
4
4
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
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
10
15
18
25
2
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