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.
Dr.Reddy's Laboratories Limited
SQUARE BROWN R 725
R 725 SQUARE BROWN
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16 HOW SUPPLIED/STORAGE AND HANDLING
MONTELUKAST SODIUM tablets USP, 10 mg (montelukast) are brown colored, rounded square-shaped, film coated tablets debossed with ‘R’ on one side and ‘725’ on the other side. They are supplied in bottles of 30’s, 90's, 100’s, 1000’s and unit dose package of 100 (10 x 10). Bottles of 30 NDC 55111-725-30 Bottles of 90 NDC 55111-725-90 Bottles of 100 NDC 55111-725-01 Bottles of 1000 NDC 55111-725-10 Unit Dosage Package of 100 (10x10) NDC 55111-725-78
MONTELUKAST SODIUM chewable tablets, 4 mg (montelukast) are light pink to pink colored, speckled oval shaped, biconvex tablets debossed with ‘R’ on one side and ‘593’ on the other side. They are supplied in bottles of 30’s, 90’s, 500’s and unit dose package of 100 (10 x 10). Bottles of 30 NDC 55111-593-30 Bottles of 90 NDC 55111-593-90 Bottles of 500 NDC 55111-593-05 Unit Dosage Package of 100 (10x10) NDC 55111-593-78
MONTELUKAST SODIUM chewable tablets, 5 mg (montelukast) are light pink to pink colored, speckled round shaped, biconvex tablets debossed with ‘R’ on one side and ‘594’ on the other side. They are supplied in bottles of 30’s, 90’s, 500’s and unit dose package of 100 (10 x 10). Bottles of 30 NDC 55111-594-30 Bottles of 90 NDC 55111-594-90 Bottles of 500 NDC 55111-594-05 Unit Dosage Package of 100 (10x10) NDC 55111-594-78 Storage Store
MONTELUKAST SODIUM 10 mg (montelukast) film coated tablets, 4 mg chewable tablets and 5 mg chewable tablets 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.
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