Allegra-D
INDICATIONS
ALLEGRA-D 12 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 12 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 12 HOUR Extended-Release Tablets is one tablet twice daily administered on an empty stomach with water for adults and children 12 years of age and older. It is recommended that the administration of ALLEGRA-D 12 HOUR 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.)
ALLEGRA-D 12 HOUR must be swallowed whole and never crushed or chewed. Occasionally, the inactive ingredients of ALLEGRA-D 12 HOUR may be eliminated in the feces in a form that may resemble the original tablet. (See PRECAUTIONS, Information for Patients.)
HOW SUPPLIED
ALLEGRA-D 12 HOUR Extended-Release Tablets contain 60 mg fexofenadine hydrochloride for immediate release and 120 mg pseudoephedrine hydrochloride for extended release. ALLEGRA-D 12 HOUR Extended-Release Tablets are available in high-density polyethylene (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 12 HOUR 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 ”06/012D” on the white layer.
Store ALLEGRA-D 12 HOUR Extended-Release Tablets at 20-25°C (68-77°F). (See USP Controlled Room Temperature.)
Rev. June 2006. Sanofi-aventis U.S. LLC Bridgewater, NJ 08807. FDA rev date: 12/6/2004
Generic Name: Fexofenadine HCl and Pseudoephedrine HCl
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