montelukast 5 MG Chewable 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.
Aurobindo Pharma Limited
ROUND PINK X 53
X 53 ROUND PINK
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16 HOW SUPPLIED/STORAGE AND HANDLING
MONTELUKAST SODIUM Tablets USP:
MONTELUKAST SODIUM Tablets USP, 10 mg are beige, rounded square shaped, film-coated tablets debossed with ‘X’ on one side and ‘54’ on other side. Bottles of 30 NDC 65862-574-30 Bottles of 90 NDC 65862-574-90 Bottles of 10,000 NDC 65862-574-19 Cartons of 100 (10 x 10) Unit-dose Tablets NDC 65862-574-10
MONTELUKAST SODIUM Chewable Tablets USP:
MONTELUKAST SODIUM Chewable Tablets USP, 4 mg are pink colored, oval, biconvex, uncoated tablets debossed with ‘X’ on one side and ‘52’ on other side. The tablets may be mottled. Bottles of 30 NDC 65862-567-30 Bottles of 90 NDC 65862-567-90 Bottles of 500 NDC 65862-567-05
MONTELUKAST SODIUM Chewable Tablets USP, 5 mg are pink colored, round, biconvex, uncoated tablets debossed with ‘X’ on one side and ‘53’ on other side. The tablets may be mottled. Bottles of 30 NDC 65862-568-30 Bottles of 90 NDC 65862-568-90 Bottles of 500 NDC 65862-568-05 Storage Store montelukast 4 mg chewable tablets, 5 mg chewable tablets and montelukast 10 mg film-coated tablets at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture and light. Store in original package. Storage for Bulk Bottles Store bottles of 10,000 montelukast 10 mg film-coated tablets and 500 montelukast 4 mg, 5 mg chewable tablets at 20° to 25°C (68° to 77°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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