montelukast 10 mg oral tablet
1. INDICATIONS AND USAGE Montelukast sodium tablets are a leukotriene receptor antagonist indicated for: • Prophylaxisand chronic treatment of asthma inpatients 12 months of age and older(1.1 ). • Acuteprevention of exercise-induced bronchoconstriction(EIB) in patients 15 years of ageand older (1.2). • Relief'of symptoms of allergic rhinitis (AR):seasonal allergic rhinitis (SAR) in patients2 years of age and older , andperennial allergic rhinitis (PAR) in patients6 months of age and older (1.3). 1.1 Asthma Montelukast sodium is indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 12 months of age and older. 1.2 Exercise-Induced Bronchoconstriction Montelukast sodium is 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 is indicated for the relief of symptoms of seasonal allergic rhinitis in patients 2 years of age and older and perennial allergic rhinitis in patients 6 months of age and older.
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ROUND BROWN 1081 10mg
1081 10mg ROUND BROWN
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16. HOW SUPPLIED/STORAGE AND HANDLING
MONTELUKAST SODIUM tablets, 10 mg, are light brown colored, round, biconvex film coated tablets debossed with "1081" on one side and "10MG" on other side. They are supplied as follows: Bottles of 30 NDC 63187-430-30 Bottles of 60 NDC 63187-430-60 Bottles of 90 NDC 63187-430-90 Storage Store
MONTELUKAST SODIUM tablets at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from moisture and light. Store in original container.
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