montelukast 10 MG Oral Tablet
1 INDICATIONS AND USAGE Montelukast sodium is 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. Reserve use for patients who have an inadequate response or intolerance to alternative therapies ( 1.3 ). Limitations of Use: Not indicated to treat an acute asthma attack ( 5.2 ). 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. Because the benefits of montelukast sodium may not outweigh the risk of neuropsychiatric symptoms in patients with allergic rhinitis [see Warnings and Precautions ( 5.1 )], reserve use for patients who have an inadequate response or intolerance to alternative therapies. 1.4 Limitations of Use Montelukast Sodium is not indicated for the treatment of an acute asthma attack..
Unichem Pharmaceuticals (USA), Inc.
ROUND YELLOW U 220
U 220 ROUND YELLOW
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16 HOW SUPPLIED/STORAGE AND HANDLING
MONTELUKAST SODIUM tablets USP, 10 mg are pale yellow coloured, round shaped, film coated tablets with 'U' debossed on one side and '220' on other side. Bottles of 30 (NDC# 29300-220-13) Bottles of 90 (NDC# 29300-220-19) Bottles of 100 (NDC# 29300-220-01) Bottles of 1000 (NDC# 29300-220-10)
MONTELUKAST SODIUM chewable tablets USP, 5 mg are light yellow coloured, round shaped biconvex tablets, debossed with '222' on one side and 'U' on other side. Bottles of 30 (NDC# 29300-222-13) Bottles of 90 (NDC# 29300-222-19) Bottles of 1000 (NDC# 29300-222-10)
MONTELUKAST SODIUM chewable tablets USP, 4 mg are light yellow coloured, round shaped biconvex tablets, debossed with '221' on one side and 'U' on other side. Bottles of 30 (NDC# 29300-221-13) Bottles of 90 (NDC# 29300-221-19) Bottles of 1000 (NDC# 29300-221-10) Storage Store
MONTELUKAST SODIUM chewable tablets and 10-mg film-coated tablets at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 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 chewable tablets and 10-mg film coated tablets at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 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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