CLARINEX 125 DT 3 TABLET

INTRODUCTION

CLARINEX (desloratadine) Tablets are light blue, round, film-coated tablets containing 5 mg desloratadine, an antihistamine, to be administered orally. CLARINEX Tablets also contain the following excipients: dibasic calcium phosphate dihydrate USP, microcrystalline cellulose NF, corn starch NF, talc USP, carnauba wax NF, white wax NF, coating material consisting of lactose monohydrate, hypromellose, titanium dioxide, polyethylene glycol, and FD&C Blue #2 Aluminum Lake.

CLARINEX Oral Solution is a clear orange-colored liquid containing 0.5 mg/1 mL desloratadine. The Oral Solution contains the following inactive ingredients: propylene glycol USP, sorbitol solution USP, citric acid (anhydrous) USP, sodium citrate dihydrate USP, sodium benzoate NF, disodium edetate USP, purified water USP. It also contains granulated sugar, natural and artificial flavor for bubble gum, and FDC Yellow #6 dye.

Desloratadine 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)-5H-benzo[5,6]cyclohepta[1,2-b]pyridine and has the following structure: