BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE syrup

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

Mayne Pharma

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

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.

Přehled produktů:

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 containers of 4 fluid ounces (118 mL), NDC 51862-535-04 and 16 fluid ounces (473 mL), NDC 51862-535-16.

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND
DEXTROMETHORPHAN HYDROBROMIDE- BROMPHENIRAMINE MALEATE,
PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP
MAYNE PHARMA
----------
BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND
DEXTROMETHORPHAN HYDROBROMIDE SYRUP
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: citric acid anhydrous, dehydrated alcohol, FD&C
Red No. 40,
glycerin, methylparaben, propylene glycol, purified water, sodium
benzoate, and sucrose
with butterscotch flavor. It may contain sodium citrate for pH
adjustment. The pH range
is between 4.0 and 6.0.
C
H
BrN
•C
H
O
M.W. 435.31
BROMPHENIRAMINEMALEATE, USP
(±)-2- _P_-BROMO-Α-2-(DIMETHYLAMINO)ETHYLBENZYLPYRIDINEMALEATE (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
DEXTROMETHORPHANHYDROBROMIDE, USP
3-METHOXY-17-METHYL-9Α, 13Α, 14Α -MORPHINANHYDROBROMIDE 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