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

INDICATIONS AND USAGE

ALLEGRA-D is 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 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 is one tablet twice daily for adults and children 12 years of age and older. It is recommended that the administration of ALLEGRA-D with food should be avoided. A dose of one tablet once daily is recommended as the starting dose in patients with decreased renal function. (See CLINICAL PHARMACOLOGY and PRECAUTIONS.)

HOW SUPPLIED

ALLEGRA-D (fexofenadine hydrochloride and pseudoephedrine hydrochloride) Extended-Release Tablets contain 60 mg fexofenadine hydrochloride for immediate-release and 120 mg pseudoephedrine hydrochloride for extended-release. ALLEGRA-D (fexofenadine hydrochloride and pseudoephedrine hydrochloride) Extended-Release Tablets are available in: high-density polyethylene (HDPE) bottles of 60 (NDC 0088-1090-41) with a polypropylene child-resistant cap containing a pulp/wax liner with heat-sealed foil inner seal; HDPE bottles of 100 (NDC 0088-1090-47) with a polypropylene screw cap containing a pulp/wax liner with heat-sealed foil inner seal; HDPE bottles of 500 (NDC 0088-1090-55) with a polypropylene screw cap containing a pulp/wax liner with heat-sealed foil inner seal; and aluminum foil-backed clear blister packs of 100 (NDC 0088-1090-49).

ALLEGRA-D is a two-layer tablet, one white layer and one tan layer with a clear film coating on the tablet. The tablets are engraved with "Allegra-D" on the white layer.

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

Rx only

Prescribing Information as of January 2003

Aventis Pharmaceuticals Inc.

Kansas City, MO 64137 USA

US Patents 4,254,129; 5,375,693; 5,578,610.

©2003 Aventis Pharmaceuticals Inc.

www.allegra.com

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