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.

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.

ALLEGRA Tablets

Seasonal Allergic Rhinitis and Chronic Idiopathic Urticaria

Adults and Children 12 Years and Older. The recommended dose of ALLEGRA tablets is 60 mg twice daily or 180 mg once daily with water. A dose of 60 mg once daily is recommended as the starting dose in patients with decreased renal function [See CLINICAL PHARMACOLOGY].

Children 6 to 11 Years. The recommended dose of ALLEGRA tablets is 30 mg twice daily with water. A dose of 30 mg once daily is recommended as the starting dose in pediatric patients with decreased renal function [see CLINICAL PHARMACOLOGY].

ALLEGRA ODT

Seasonal Allergic Rhinitis and Chronic Idiopathic Urticaria

Children 6 to 11 Years. ALLEGRA ODT is intended for use only in children 6 to 11 years of age. The recommended dose of ALLEGRA ODT is 30 mg twice daily. A dose of 30 mg once daily is recommended as the starting dose in pediatric patients with decreased renal function [see CLINICAL PHARMACOLOGY].

ALLEGRA ODT is designed to disintegrate on the tongue, followed by swallowing with or without water. ALLEGRA ODT should be taken on an empty stomach. ALLEGRA ODT is not intended to be chewed.

ALLEGRA ODT should not be removed from the original blister package until the time of administration.

ALLEGRA oral suspension

Seasonal Allergic Rhinitis

Children 2 to 11 Years: The recommended dose of ALLEGRA oral suspension is 30 mg twice daily. A dose of 30 mg (5 mL) once daily is recommended as the starting dose in pediatric patients with decreased renal function [see CLINICAL PHARMACOLOGY].

Shake bottle well, before each use.

Chronic Idiopathic Urticaria

Children 6 Months to 11 years: The recommended dose of ALLEGRA oral suspension is 30 mg (5 mL) twice daily for patients 2 to 11 years of age and 15 mg (2.5 mL) twice daily for patients 6 months to less than 2 years of age. For pediatric patients with decreased renal function, the recommended starting doses of ALLEGRA oral suspension are 30 mg (5 mL) once daily for patients 2 to 11 years of age and 15 mg (2.5 mL) once daily for patients 6 months to less than 2 years of age [see CLINICAL PHARMACOLOGY].

Shake bottle well, before each use.

Dosage Forms And Strengths

ALLEGRA tablets are available in 30 mg, 60 mg, and 180 mg strengths. 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.

ALLEGRA ODT is available as a 30 mg orally disintegrating tablet and 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. ALLEGRA oral suspension is available as 30 mg/ 5 mL (6 mg/mL).

AND STORAGE AND HANDLING

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.

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.

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.

sanofi-aventis U.S., LLC Bridgewater, NJ 08807
ALLEGRA ODT manufactured for: sanofi-aventis U.S., LLC Bridgewater, NJ 08807
©2007 sanofi-aventis U.S. LLC. FDA rev date: 7/26/2007

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