montelukast 10 mg
1 INDICATIONS AND USAGE Montelukast sodium tablets are a leukotriene receptor antagonist indicated for: Prophylaxis and chronic treatment of asthma in patients 15 years of age and older ( 1.1 ). Acute prevention of exercise-induced bronchoconstriction (EIB) in patients 15 years of age and older ( 1.2 ). Relief of symptoms of allergic rhinitis (AR): seasonal allergic rhinitis (SAR) in patients 15 years of age and older, and perennial allergic rhinitis (PAR) in patients 15 years of age and older ( 1.3 ). 1.1 Asthma Montelukast sodium tablets are indicated for the prophylaxis and chronic treatment of asthma in patients 15 years of age and older. 1.2 Exercise-Induced Bronchoconstriction (EIB) Montelukast sodium tablets are indicated for prevention of exercise-induced bronchoconstriction (EIB) in patients 15 years of age and older. Pediatric use information for patients ages 6 to 14 years of age for acute prevention of exercise-induced bronchoconstriction (EIB) is approved for Merck Sharp & Dohme Corp’s montelukast tablet products. However, due to Merck Sharp & Dohme Corp’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. 1.3 allergic rhinitis Montelukast sodium tablets are indicated for the relief of symptoms of seasonal allergic rhinitis in patients 15 years of age and older and perennial allergic rhinitis in patients 15 years of age and older.
Aurobindo Pharma Limited
SQUARE BROWN 54 X
54 X SQUARE BROWN
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16 HOW SUPPLIED/STORAGE AND HANDLING Montelukast Sodium Tablets, 10 mg are beige, rounded square shaped, film-coated tablets debossed with ‘X’ on one side and ‘54’ on other side. Bottles of 30 NDC 65862-574-30 Bottles of 90 NDC 65862-574-90 Bottles of 10000 NDC 65862-574-19 Cartons of 100 (10 x 10) Unit-dose Tablets NDC 65862-574-10 Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture and light. Store in original package. Storage for Bulk Bottles Store bottles of 10000 at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture and light. Store in original container. When product container is subdivided, repackage into a well-closed, light-resistant container.
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