ZYRTEC-D 12 HOUR® (cetirizine hydrochloride 5 mg and pseudoephedrine hydrochloride 120 mg) Extended Release Tablets For Oral Use
DESCRIPTION
ZYRTEC-D 12 HOUR™ (cetirizine hydrochloride 5 mg and pseudoephedrine hydrochloride 120 mg) Extended Release Tablets for oral administration contain 5 mg of cetirizine hydrochloride for immediate release and 120 mg of pseudoephedrine hydrochloride for extended release in a bilayer tablet. Tablets also contain as inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose.
Cetirizine hydrochloride, one of the two active components of ZYRTEC-D 12 HOUR Extended Release Tablets, is an orally active and selective H1-receptor antagonist. The chemical name is (+/−)- [2-[4-[(4-chlorophenyl)phenylmethyl]-1-piperazinyl] ethoxy] acetic acid, dihydrochloride. Cetirizine hydrochloride is a racemic compound with an empirical formula of C21H25ClN2O3•2HCl. The molecular weight is 461.82. Cetirizine hydrochloride is a white, crystalline powder and is water-soluble. The chemical structure is shown below:
Pseudoephedrine hydrochloride, the other active ingredient of ZYRTEC-D 12 HOUR Extended Release Tablets, is an adrenergic (vasoconstrictor) agent with the chemical name (1S.2S)-2-methylamino-1-phenyl-1-propanol hydrochloride. The molecular weight is 201.70. The molecular formula is C10H15NO•HCl. Pseudoephedrine hydrochloride occurs as fine, white to off-white crystals or powder, having a faint characteristic odor. It is very soluble in water, freely soluble in alcohol, and sparingly soluble in chloroform. The chemical structure is shown below:
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