Allegra-D 24 Hour (Fexofenadine Hydrochloride / Pseudoephedrine Hydrochloride) - Indications and Dosage

INDICATIONS AND USAGE

ALLEGRA-D 24 HOUR Extended-Release Tablets are indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children 12 years of age and older. Symptoms treated effectively include sneezing, rhinorrhea, itchy nose/palate/ and/or throat, itchy/watery/red eyes, and nasal congestion.

ALLEGRA-D 24 HOUR should be administered when both the antihistaminic properties of fexofenadine hydrochloride and the nasal decongestant properties of pseudoephedrine hydrochloride are desired (see CLINICAL PHARMACOLOGY).

DOSAGE AND ADMINISTRATION

The recommended dose of ALLEGRA-D 24 HOUR Extended-Release Tablets is one tablet once daily administered on an empty stomach with water for adults and children 12 years of age and older. ALLEGRA-D 24 HOUR tablets should generally be avoided in patients with renal insufficiency. ALLEGRA-D 24 HOUR must be swallowed whole and never crushed or chewed.

HOW SUPPLIED

ALLEGRA-D 24 HOUR Extended-Release Tablets contain 180 mg fexofenadine hydrochloride for immediate release and 240 mg pseudoephedrine hydrochloride for extended release. ALLEGRA-D 24 HOUR Extended-Release Tablets are available in high-density polyethylene (HDPE) bottles of 100 (NDC 0088-1095-47) and 500 (NDC 0088-1095-55), each with an activated charcoal pouch. All bottles have a polypropylene screw cap containing a pulp/wax liner with heat-sealed foil inner seal.

ALLEGRA-D 24 HOUR Extended-Release Tablet is a white, round, film coated tablet. The tablet has 308AV printed on one side in black ink.

Store ALLEGRA-D 24 HOUR Extended-Release Tablets at 20–25°C (68–77°F). (See USP Controlled Room Temperature.)