BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE syrup

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Nopērc to tagad

Lejuplādēt Produkta apraksts (SPC)
08-04-2022

Aktīvā sastāvdaļa:

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

Pieejams no:

Bryant Ranch Prepack

Ievadīšanas:

ORAL

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

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 (MAO) inhibitors (see PRECAUTIONS - Drug Interactions ). Antihistamines should not be used to treat lower respiratory tract conditions including asthma.

Produktu pārskats:

Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide Syrup is a clear, light pink-colored, peach-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 (118mL) – NDC 63629-2059-1 RECOMMENDED STORAGE 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.

Autorizācija statuss:

Abbreviated New Drug Application

Produkta apraksts

                                BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND
DEXTROMETHORPHAN HYDROBROMIDE- BROMPHENIRAMINE MALEATE,
PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP
BRYANT RANCH PREPACK
----------
BROMPHENIRAMINE MALEATE 2 MG,
PSEUDOEPHEDRINE HYDROCHLORIDE
30 MG, AND DEXTROMETHORPHAN
HYDROBROMIDE 10 MG SYRUP
Breckenridge Pharmaceutical, Inc.
RX ONLY
DESCRIPTION
Brompheniramine Maleate, Pseudoephedrine Hydrochloride and
Dextromethorphan
Hydrobromide Syrup is a clear, light pink syrup with a peach flavor.
EACH 5 ML (1 TEASPOONFUL) CONTAINS:
Brompheniramine Maleate, USP
2 mg
Pseudoephedrine Hydrochloride,
USP
30 mg
Dextromethorphan Hydrobromide,
USP
10 mg
C
H
BrN ∙C H O M.W. 435.31
BROMPHENIRAMINE MALEATE, USP
(±)-2- _P_-BROMO-Α-2-(DIMETHYLAMINO) ETHYLBENZYLPYRIDINE MALEATE
(1:1)
16
19
2
4
4
4
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
In a palatable, aromatic vehicle.
Inactive Ingredients: citric acid anhydrous, FD&C Red No. 40,
glycerin, methylparaben,
natural peach flavor, propylene glycol, purified water, sodium
benzoate, sodium citrate
dihydrate and sucrose. 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
gastrointestina
                                
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