Telfast/Telfast Oral Suspension Description

Fexofenadine HCl is an equimolar mixture of two enantiomers. The molecular formula is C₃₂H₃₉NO₄·HCl and the molecular weight is 538.13.
Fexofenadine is the carboxylic acid metabolite of terfenadine. It is an orally-active non-sedating histamine H₁-receptor antagonist that is administered as the hydrochloride salt in Telfast. The chemical name is benzeneacetic acid, 4-[1-hydroxy-4-[4-(hydroxydiphenylmethyl)-1-piperidinyl]butyl]-α,α-dimethyl-, hydrochloride.
Fexofenadine occurs as a fine white to off-white powder. It is freely soluble in methanol, soluble in ethanol, slightly soluble in water (3.6 mg/mL) and only very slightly soluble in chloroform and hexane.
Film-coated tablet: Each tablet contains 120 mg of fexofenadine hydrochloride, which is equivalent to 112 mg of fexofenadine.
Each tablet contains 180 mg of fexofenadine hydrochloride, which is equivalent to 168 mg of fexofenadine.
Oral suspension: Each mL contains fexofenadine HCl 6 mg (30 mg/5 mL) equivalent to 5.6 mg fexofenadine.
Excipients/Inactive Ingredients: Film-coated tablet: Tablet core: Microcrystalline cellulose, pregelatinised starch, croscarmellose sodium, magnesium stearate.
Film coat: Hypromellose, povidone, titanium dioxide (E171), colloidal anhydrous silica, macrogol 400, pink iron oxide blend (120 mg only), yellow iron oxide blend (120 mg only), iron oxide blend (180 mg only).
Oral suspension: Propylene glycol, edetate disodium, propyl hydroxybenzoate, butyl hydroxybenzoate, xanthan gum, poloxamer 407, titanium dioxide, sodium phosphate monobasic monohydrate, sodium phosphate dibasic heptahydrate, artificial raspberry cream flavour (ARTG PI No. 12546), sucrose, xylitol and purified water.