CLARINEX-D® 24 HOUR
(desloratadine 5 mg and pseudoephedrine sulfate, USP 240 mg)
EXTENDED RELEASE TABLETS
PRODUCT INFORMATION
DESCRIPTION
CLARINEX-D® 24 HOUR Extended Release Tablets are light blue oval shaped tablets containing 5 mg desloratadine in the tablet coating for immediate release and 240 mg pseudoephedrine sulfate, USP in the tablet core for extended release.
The inactive ingredients contained in CLARINEX-D® 24 HOUR Extended Release Tablets are hypromellose USP, ethylcellulose NF, dibasic calcium phosphate dihydrate USP, magnesium stearate NF, povidone USP, silicone dioxide NF, talc USP, polyacrylate dispersion, polyethylene glycol NF, simethicone USP, Blue Lake Blend 50726 (FD&C Blue No. 2 Lake, titanium dioxide USP and edetate disodium USP), and ink (Opacode® S-1-17746 or Opacode® S-1-4159).
Desloratadine, one of the two active ingredients of CLARINEX-D® 24 HOUR Extended Release Tablets, is a white to off-white powder that is slightly soluble in water, but very soluble in ethanol and propylene glycol. It has an empirical formula: C19H19ClN2 and a molecular weight of 310.8. The chemical name is 8-chloro-6,11-dihydro-11-(4-piperdinylidene)-5 H -benzo[5,6]cyclohepta[1,2- b ]pyridine and has the following structure:
Pseudoephedrine sulfate, the other active ingredient of CLARINEX-D® 24 HOUR Extended Release Tablets, is the synthetic salt of one of the naturally occurring dextrorotatory diastereomers of ephedrine and is classified as an indirect sympathomimetic amine. Pseudoephedrine sulfate is a colorless hygroscopic crystal or white, hygroscopic crystalline powder, practically odorless, with a bitter taste. It is very soluble in water, freely soluble in alcohol, and sparingly soluble in ether. The empirical formula for pseudoephedrine sulfate is (C10H15NO)2• H2SO4; the chemical name is benzenemethanol, α-[1-(methylamino) ethyl]-,[ S -(R*, R*)]-, sulfate (2:1)(salt); and the chemical structure is:
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