SILDEC PE DM syrup

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

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Hent Produktets egenskaber (SPC)
13-04-2011

Aktiv bestanddel:

CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U), PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV), DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)

Tilgængelig fra:

Rebel Distributors Corp

INN (International Name):

CHLORPHENIRAMINE MALEATE

Sammensætning:

CHLORPHENIRAMINE MALEATE 4 mg in 5 mL

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

For relief of coughs and upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold. Patients with hypersensitivity or idiosyncrasy to any of its ingredients. Sympathomimetic amines are contraindicated in patients with severe hypertension, severe coronary artery disease and patients on monoamine oxidase (MAO) inhibitor therapy. Antihistamines are contraindicated in patients with narrow angle glaucoma, urinary retention, peptic ulcer and during an asthma attack. Dextromethorphan should not be used in patients receiving a monoamine oxidase inhibitor (MAOI) or for 2 weeks after stopping the MAOI drug.

Produkt oversigt:

CHLORPHENIRAMINE / PHENYLEPHRINE/ DEXTROMETHORPHAN Syrup (CPM/PE/DM Syrup) CPM/PE/DM Syrup is sugar-free, alcohol-free, and grape flavored. It is available in bottles of 16 fluid ounce (473 mL) bottles - NDC 21695-900-16 . Dispense in a tight, light-resistant container as defined in USP with a child resistant closure.

Autorisation status:

unapproved drug other

Produktets egenskaber

                                SILDEC PE DM- SILDEC PE DM SYRUP
REBEL DISTRIBUTORS CORP
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
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CHLORPHENIRAMINE / PHENYLEPHRINE/ DEXTROMETHORPHAN SYRUP (CPM/PE/DM
SYRUP)
DESCRIPTION
CPM/PE/DM Syrup is a sugar-free, alcohol-free, grape flavored syrup
for oral administration for
adults and for pediatric patients 2 years and older.
Each teaspoonful (5 mL) contains:
Chlorpheniramine maleate ………………. 4.0 mg
Phenylephrine hydrochloride ……………. 12.5 mg
Dextromethorphan hydrobromide ……….. 15.0 mg
INACTIVE INGREDIENTS: Citric acid, D&C Red No. 33, FD&C Blue No. 1,
flavor, glycerin, purified
water, sodium benzoate, sodium saccharin, and sorbitol. May contain
sodium citrate.
Chlorpheniramine maleate is an antihistamine with the chemical name:
2-Pyridinepropanamine, y -(4-
chlorophenyl)-N, N-dimethyl-, (Z)-2-butenedioate (1:1). Its chemical
structure is as follows:
Phenylephrine hydrochloride is a mydriatic and a decongestant with the
chemical name: ( )-m-Hydroxy-
α-[(methylamino)methyl]benzyl alcohol hydrochloride. Its chemical
structure is as follows:
Dextromethorphan hydrobromide is an antitussive with the chemical name
3-Methoxy-17-methyl-9α,
13α, 14α - morphinan hydrobromide monohydrate. Its structure is as
follows:
-
CLINICAL PHARMACOLOGY
Antihistaminic, decongestant and antitussive actions.
Chlorpheniramine maleate possesses H antihistaminic activity and mild
anticholinergic and sedative
effects. Peak plasma concentration is reached in 5 hours. Urinary
excretion is the major route of
elimination. The liver is assumed to be the major site of metabolic
transformation.
Phenylephrine hydrochloride is an oral sympathomimetic amine that acts
as a decongestant to respiratory
tract mucous membranes. While its vasoconstrictor action is similar to
that of ephedrine, phenylephrine
has less pressor effect in normotensive adults. Serum half-life
                                
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