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Fexofenadine hydrochloride, the active ingredient of ALLEGRA (fexofenadine hcl) tablets, ALLEGRA (fexofenadine hcl) ODT and ALLEGRA (fexofenadine hcl) oral suspension, is a histamine H1-receptor antagonist with the chemical name (±)-4-[1 nylmethyl)-1-piperidinyl]-butyl]- α, α-dimethylhydroxy-4-benzeneacetic acid hydrochloride. It has the following chemical structure
ALLEGRA® (fexofenadine hydrochloride) Structural Formula Illustration
The molecular weight is 538.13 and the empirical formula is C32H39NO4•HCl.
ALLEGRA (fexofenadine hydrochloride) is a white to off-white crystalline powder. It is freely soluble in methanol and ethanol, slightly soluble inchloroform and water, and insoluble in hexane. ALLEGRA (fexofenadine hydrochloride) is a racemate and exists as a zwitterion in aqueous media at physiological pH.
ALLEGRA (fexofenadine hcl) is formulated as a tablet for oral administration. Each tablet contains 30, 60, or 180 mg ALLEGRA (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 hypromellose, iron oxide blends, polyethylene glycol, povidone, silicone dioxide, and titanium dioxide.
ALLEGRA (fexofenadine hcl) ODT is formulated for disintegration in the mouth immediately following administration. Each orally disintegrating tablet contains 30 mg ALLEGRA (fexofenadine hydrochloride) and the following excipients: citric acid anhydrous, crospovidone, magnesium stearate, mannitol, methacrylate copolymer, microcrystalline cellulose, povidone K-30, sodium bicarbonate, sodium starch glycolate, aspartame, natural and artificial orange flavor, artificial cream flavor, and alcohol anhydrous; the alcohol is predominantly removed during the manufacturing process.
ALLEGRA (fexofenadine hcl) oral suspension, a white uniform suspension, contains 6 mg ALLEGRA (fexofenadine hydrochloride) per mL and the following excipients: propylene glycol, edetate disodium, propylparaben, butylparaben, xanthan gum, poloxamer 407, titanium dioxide, sodium phosphate monobasic monohydrate, sodium phosphate dibasic heptahydrate, artificial raspberry cream flavor, sucrose, xylitol and purified water.