Fexofenadine hydrochloride 60 MG Oral Tablet Allegra
1 INDICATIONS AND USAGE ALLEGRA is an H 1 -receptor antagonist indicated for: Relief of symptoms associated with seasonal allergic rhinitis in patients ≥ 2 years of age ( 1.1 ) Treatment of uncomplicated skin manifestations of chronic idiopathic urticaria in patients ≥ 6 months of age. ( 1.2 ) 1.1 Seasonal Allergic Rhinitis ALLEGRA is indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children 2 years of age and older. 1.2 Chronic Idiopathic Urticaria ALLEGRA is indicated for treatment of uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 months of age and older.
sanofi-aventis U.S. LLC
OVAL ORANGE 06 E
06 E OVAL ORANGE
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 ALLEGRA tablets ALLEGRA 30 mg tablets are available in: high-density polyethylene (HDPE) bottles of 100 (NDC 0088-1106-47) with a polypropylene screw cap containing a pulp/wax liner with heat-sealed foil inner seal and HDPE bottles of 500 (NDC 0088-1106-55) with a polypropylene screw cap containing a pulp/wax liner with heat-sealed foil inner seal. ALLEGRA 60 mg tablets are available in: HDPE bottles of 100 (NDC 0088-1107-47) with a polypropylene screw cap containing a pulp/wax liner with heat-sealed foil inner seal; HDPE bottles of 500 (NDC 0088-1107-55) 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 0088-1107-49). ALLEGRA 180 mg tablets are available in: HDPE bottles of 100 (NDC 0088-1109-47) with a polypropylene screw cap containing a pulp/wax liner with heat-sealed foil inner seal and HDPE bottles of 500 (NDC 0088-1109-55) with a polypropylene screw cap containing a pulp/wax liner with heat-sealed foil inner seal. ALLEGRA tablets are coated with a peach colored film coating. Tablets have the following unique shape and identifiers: 30 mg tablets are round, bi-convex and have 03 on one side and a scripted "e" on the other; 60 mg tablets are oval, bi-convex and have 06 on one side and a scripted "e" on the other; and 180 mg tablets are oblong, bi-convex and have 018 on one side and a scripted "e" on the other. Store ALLEGRA tablets at controlled room temperature 20–25°C (68–77°F). (See USP Controlled Room Temperature). Foil-backed blister packs containing ALLEGRA tablets should be protected from excessive moisture. 16.2 ALLEGRA ODT ALLEGRA ODT 30 mg orally disintegrating tablets are available in aluminum-foil blister packs of 60 (NDC 0088-1113-30). Each ALLEGRA ODT is white, flat-faced, ½-inch round shaped with beveled edges and debossed with a scripted "e" on one side and "311AV" on the other side. Store ALLEGRA ODT at controlled room temperature 20–25°C (68–77°F). (See USP Controlled Room Temperature). Foil-backed blister packs containing ALLEGRA ODT should be protected from moisture. ALLEGRA ODT should not be removed from the original blister package until the time of administration. 16.3 ALLEGRA oral suspension ALLEGRA oral suspension (fexofenadine hydrochloride, 30 mg/5 mL (6 mg/mL)) is available in an amber PET bottle containing 300 mL (NDC 0088-1097-20) of suspension. Store ALLEGRA oral suspension at controlled room temperature 20–25°C (68–77°F). (See USP Controlled Room Temperature.) Shake bottle well, before each use.
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