Source: FDA, National Drug Code (US) Revision Year: 2019
SEMPREX-D Capsules (acrivastine and pseudoephedrine hydrochloride) are a fixed combination product formulated for oral administration. Acrivastine is an antihistamine and pseudoephedrine is a decongestant. Each capsule contains 8 mg acrivastine and 60 mg pseudoephedrine hydrochloride and the inactive ingredients: lactose, magnesium stearate and sodium starch glycolate. The green and white capsule shell consists of gelatin, D&C Yellow No. 10, FD&C Green No. 3, and titanium dioxide. The capsules may contain one or more parabens and are printed with edible black and white inks.
The chemical name of acrivastine is (E,E)3[6-[1-(4-methylphenyl)3(1-pyrrolidinyl)-1-propenyl]-2-pyridinyl]-2-propenoic acid; the molecular formula is C22H24N2O2. As an analog of triprolidine hydrochloride, acrivastine is classified as an alkylamine antihistamine. Acrivastine is an odorless, white to pale cream crystalline powder that is soluble in chloroform and alcohol and slightly soluble in water.
The chemical name of pseudoephedrine hydrochloride is [S-(R *,R *)]α[1-(methylamino)ethyl]benzenemethanol hydrochloride; the molecular formula is C10H15NO•HCl. Pseudoephedrine is one of the naturally occurring dextrorotatory diastereoisomers of ephedrine and is classified as an indirect sympathomimetic amine. Pseudoephedrine hydrochloride occurs as odorless, fine white to off-white crystals or powder; the drug is soluble in water, alcohol and chloroform.
Structural formulae for the active ingredients of SEMPREX-D Capsules are as follows:
| How Supplied |
|---|
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SEMPREX-D Capsules (dark green opaque cap and white opaque body) contain acrivastine 8 mg and pseudoephedrine hydrochloride 60 mg. The cap is printed with “404” in white ink, and the body is printed with “SEMPREX-D” in black ink. NDC 52244-404-10 Bottle of 100 |
| Drug | Countries | |
|---|---|---|
| SEMPREX D | United States |
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