BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, syrup

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

Eywa Pharma Inc

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

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.

ملخص المنتج:

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 the following sizes: 4 fl oz (118 mL)                             NDC 71930-026-18 1 pint (473 mL)                              NDC 71930-026-43 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 Rx Only Manufactured by: WES Pharma Inc Westminster, MD – 21157 USA Distributed by: Eywa Pharma Inc., 2 Research Way, Floor 3, Princeton, NJ 08540 REV. 04/20

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, -
BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, SYRUP
EYWA PHARMA INC
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BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND
DEXTROMETHORPHAN
HYDROBROMIDE SYRUP,
2 MG/30 MG/10 MG PER 5 ML
RX ONLY
DESCRIPTION
Brompheniramine maleate, pseudoephedrine hydrochloride, and
dextromethorphan hydrobromide syrup,
2 mg/30 mg/10 mg per 5 mL is a clear, light pink syrup with a
butterscotch flavour.
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: artificial butterscotch flavor, citric acid
anhydrous, alcohol, FD&C Red No. 40,
glycerin, sucrose, methylparaben, propylene glycol, purified water and
sodium benzoate. It may contain
10% citric acid solution or 10% sodium citrate solution for pH
adjustment. The pH range is between
4.0 and 6.0.
BROMPHENIRAMINE MALEATE, USP(±)-2-
_P_-BROMO-Α-2-(DIMETHYLAMINO)ETHYLBENZYLPYRIDINE MALEATE
(1:1)
PSEUDOEPHEDRINE HYDROCHLORIDE, USP (+)-PSEUDOEPHEDRINE HYDROCHLORIDE
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 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 pr