levocetirizine 5 mg
1 INDICATIONS AND USAGE Levocetirizine dihydrochloride tablets are a histamine H 1 -receptor antagonist indicated for: • The relief of symptoms associated with perennial allergic rhinitis ( 1.1 ) • The treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria ( 1.2 ) 1.1 Perennial Allergic Rhinitis Levocetirizine dihydrochloride tablets are indicated for the relief of symptoms associated with perennial allergic rhinitis in children 6 months to 2 years of age. 1.2 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 months of age and older.
glenmark pharmaceuticals inc., usa
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16 HOW SUPPLIED/STORAGE AND HANDLING
LEVOCETIRIZINE DIHYDROCHLORIDE Tablets, USP are white, oval, film-coated biconvex tablets, one side embossed with ‘G’ break line ‘G’ and the other side plain and contain 5 mg
LEVOCETIRIZINE DIHYDROCHLORIDE, USP. They are available as follows: HDPE bottles of 30 tablets with child-resistant closures (NDC 68462-346-30) HDPE bottles of 90 tablets with child-resistant closures (NDC 68462-346-90) HDPE bottles of 180 tablets with child-resistant closures (NDC 68462-346-18) HDPE bottles of 500 tablets with continuous thread closures (NDC 68462-346-05) HDPE bottles of 1,000 tablets with continuous thread closures (NDC 68462-346-10) Cartons of 50 tablets (NDC 68462-346-11) containing 5 x 10 Unit-Dose Blisters (NDC 68462-346-40) Storage Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
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