Fexofenadine HCl is a histamine H1- receptor antagonist with chemical name (±)-4-[1-hydroxy-4-[4-(hydroxydiphenylmethyl)-1-piperidinyl]-butyl]-α,α-dimethyl 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 physiological pH.
Oral suspension: Each mL contains fexofenadine hydrochloride (equivalent to 5.6 mg of fexofenadine) 6 mg.
Excipients/Inactive Ingredients: Tablet: Croscarmellose sodium, magnesium stearate, microcrystalline cellulose, pregelatinized maize starch. The aqueous tablet film coating is made from hydroxypropyl methylcellulose, iron oxide, polyethylene glycol, povidone, silicon dioxide and titanium dioxide.
Oral suspension: Propylene glycol, disodium EDTA, propylparaben, butylparaben, xanthan gum, poloxamer, titanium dioxide, monobasic monohydrate sodium phosphate, dibasic heptahydrate sodium phosphate, artificial raspberry flavoring cream, sucrose, xylitol and purified water.