DESCRIPTION

Fexofenadine HCl is a histamine H₁-receptor antagonist with the chemical name (±)-4-[1-hydroxy-4-[4(hydroxydiphenylmethyl)-l¾piperidinyl]¾butyl]-a,a¾dimethyl benzeneacetic acid hydrochloride. The molecular weight is 538.13 and the empirical formula is C₃₂H₃₉NO₄·HCl. Fexofenadine HCl is a white to off-white crystalline powder. It is freely soluble in methanol and ethanol, slightly soluble in chloroform and water, and insoluble in hexane. Fexofenadine HCl is a racemate and exists as a zwitterion in aqueous media at a physiological pH.

Each tablet contains 30, 60, or 180 mg fexofenadine hydrochloride (depending on the dosage strength) and the following excipients: croscarmellose sodium, magnesium stearate, microcrystalline cellulose, and pregelatinized starch. The aqueous tablet film coating is made from hydroxypropyl methylcellulose, iron oxide blends, polyethylene glycol, povidone, silicone dioxide, and titanium dioxide.