levocetirizine dihydrochloride 5 mg
1 INDICATIONS AND USAGE Enter section text here Levocetirizine dihydrochloride tablets are a histamine H 1 -receptor antagonist indicated for: The relief of symptoms associated with seasonal and perennial allergic rhinitis ( 1.1 , 1.2 ) The treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria ( 1.3 ) 1.1 Seasonal Allergic Rhinitis Levocetirizine dihydrochloride tablets are indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children 6 years of age and older. Pediatric use information in pediatric patients (age 2 to 5 years) with seasonal allergic rhinitis is approved for UCB Inc.'s levocetirizine dihydrochloride drug product. However, due to UCB Inc.'s marketing exclusivity rights; this drug product is not labeled for such use in those pediatric patients. 1.2 Perennial Allergic Rhinitis Levocetirizine dihydrochloride tablets are indicated for the relief of symptoms associated with perennial allergic rhinitis in adults and children 6 years of age and older. Pediatric use information in pediatric patients (age 6 months to 5 years) with perennial allergic rhinitis is approved for UCB Inc.'s levocetirizine dihydrochloride drug product. However, due to UCB Inc.'s marketing exclusivity rights; this drug product is not labeled for such use in those pediatric patients. 1.3 Chronic Idiopathic Urticaria Levocetirizine dihydrochloride tablets are indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 years of age and older. Pediatric use information in pediatric patients (age 6 months to 5 years) with chronic idiopathic urticaria is approved for UCB Inc.'s levocetirizine dihydrochloride drug product. However, due to UCB Inc.'s marketing exclusivity rights; this drug product is not labeled for such use in those pediatric patients.
physicians total care, inc.
OVAL WHITE L9CZ 5
L9CZ 5 OVAL WHITE
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levocetirizine dihydrochloride 5 mg
physicians total care, inc.
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16 HOW SUPPLIED/STORAGE AND HANDLING Levocetirizine dihydrochloride tablets are white to off-white, film-coated, scored, oval, biconvex, debossed with "L9CZ 5" on the unscored side and nothing on the scored side, and contain 5 mg levocetirizine dihydrochloride. They are supplied in unit of use HDPE bottles. Bottles of 30 NDC 54868-2077-0 Bottles of 90 NDC 54868-2077-1 Storage: Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].
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