montelukast tablet film coated montelukast tablet chewable
1. INDICATIONS AND USAGE Montelukast sodium tablets are a leukotriene receptor antagonist indicated for: Prophylaxis and chronic treatment of asthma in patients 2 years of age and older ( 1.1 ). Acute prevention of exercise-induced bronchoconstriction (EIB) in patients 6 years of age and older ( 1.2 ). Relief of symptoms of allergic rhinitis (AR): seasonal allergic rhinitis (SAR) in patients 2 years of age and older, and perennial allergic rhinitis (PAR) in patients 2 years 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 2 years of age and older. 1.2 Exercise-Induced Bronchoconstriction (EIB) Montelukast sodium is indicated for prevention of exercise-induced bronchoconstriction (EIB) in patients 6 years of age and older. 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 2 years of age and older.
west ward pharmaceutical corp
ROUND BROWN AUM 101
AUM 101 ROUND BROWN
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16. HOW SUPPLIED/STORAGE AND HANDLING Montelukast sodium film-coated, 10 mg, are beige, rounded, bi-convex-shaped, debossed with "AUM101" on one side and plain on the other side. They are supplied as follows: Bottles of 30 NDC 0143-9649-30 Bottles of 90 NDC 0143-9649-09 Bottles of 1,000 NDC 0143-9649-10 Montelukast sodium chewable tablets, 5 mg, are pink, rounded, bi-convex-shaped, debossed with "AUM102" on one side and plain on the other side. They are supplied as follows: Bottles of 30 NDC 0143-9650-30 Bottles of 90 NDC 0143-9650-09 Bottles of 1,000 NDC 0143-9650-10 Montelukast sodium chewable tablets, 4 mg, are pink colored, oval, bi-convex-shaped, debossed with "AUM103" on one side and plain on the other side. They are supplied as follows: Bottles of 30 NDC 0143-9651-30 Bottles of 90 NDC 0143-9651-09 Bottles of 1,000 NDC 0143-9651-10 Storage Store montelukast sodium 10 mg film coated tablets, 5-mg chewable tablets and 4-mg chewable tablets at 25°C (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 package. Storage for Bulk Bottles Store bottles of 1000 montelukast sodium-10 mg film coated tablets at 25°C (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. When product container is subdivided, repackage into a well- closed, light-resistant container.
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