montelukast 10 MG Oral Tablet
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. 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.
sandoz inc
ROUND BROWN SZ 344
SZ 344 ROUND BROWN
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16 HOW SUPPLIED/STORAGE AND HANDLING
MONTELUKAST sodium tablets, 10 mg are beige colored, round, biconvex, film coated tablets with "SZ 344" debossed on one side and plain on other side. They are available as follows: NDC 0781-5560-31, bottles of 30 tablets NDC 0781-5560-92, bottles of 90 tablets NDC 0781-5560-13, carton of 100 tablets (10 x 10 Unit-dose)
MONTELUKAST sodium chewable tablets, 4 mg are pink colored, round, mottled, and debossed with “SZ 74” on one side and plain on the other side. They are available as follows: NDC 0781-5554-31, bottles of 30 tablets NDC 0781-5554-92, bottles of 90 tablets NDC 0781-5554-05, bottles of 500 tablets NDC 0781-5554-64, carton of 30 tablets (3 x 10 Unit-dose) NDC 0781-5554-13, carton of 100 tablets (10 x 10 Unit-dose)
MONTELUKAST sodium chewable tablets, 5 mg are pink colored, round, mottled, and debossed with “SZ 76” on one side and plain on other side. They are available as follows: NDC 0781-5555-31, bottles of 30 tablets NDC 0781-5555-92, bottles of 90 tablets NDC 0781-5555-05, bottles of 500 tablets NDC 0781-5555-64, carton of 30 tablets (3 x 10 Unit-dose) NDC 0781-5555-13, carton of 100 tablets (10 x 10 Unit-dose) Storage Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Protect from moisture and light. Store in original package. Storage for Bulk Bottles Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Protect from moisture and light. Store in original package. When product container is subdivided, repackage into a well-closed, light-resistant container.
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