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Allegra D

[Fexofenadine/Pseudoephedrine]


Indications & 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

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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.









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