levocetirizine dihydrochloride 5 MG Oral Tablet
1 INDICATIONS AND USAGE Levocetirizine Dihydrochloride is 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 is indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children 2 years of age and older. 1.2 Perennial Allergic Rhinitis Levocetirizine Dihydrochloride is indicated for the relief of symptoms associated with perennial allergic rhinitis in adults and children 6 months of age and older. 1.3 Chronic Idiopathic Urticaria Levocetirizine Dihydrochloride is indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 months of age and older.
Winthrop U.S.
OVAL WHITE Y Y
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16 HOW SUPPLIED/STORAGE AND HANDLING Levocetirizine Dihydrochloride tablets are white, film-coated, oval-shaped, scored, imprinted (with the letter Y in red color on both halves of the scored tablet) and contain 5 mg levocetirizine dihydrochloride. They are supplied in unit of use HDPE bottles. 90 Tablets (NDC 0955-1025-90) Levocetirizine Dihydrochloride oral solution is a clear, colorless liquid containing 0.5 mg of levocetirizine dihydrochloride per mL. Oral Solution in 5 oz polypropylene bottles (NDC 0955-1026-21) 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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