Montelukast Sodium 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 tablets and montelukast sodium chewable tablets are 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 tablets and montelukast sodium chewable tablets are indicated for prevention of exercise-induced bronchoconstriction (EIB) in patients 6 years of age and older. 1.3 allergic rhinitis Montelukast sodium tablets and montelukast sodium chewable tablets are 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 tablets and montelukast sodium chewable tablets are not indicated for the treatment of an acute asthma attack.
Roxane Laboratories, Inc.
ROUND BROWN 54 157
54 157 ROUND BROWN
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16 HOW SUPPLIED/STORAGE AND HANDLING Montelukast Sodium Tablets, USP The 10 mg (base) tablets are supplied as light tan, round, biconvex film-coated tablets; with product identification “54” over “157” on one side and plain on the other side. NDC 0054-0259-13: Bottle of 30 Tablets NDC 0054-0259-22: Bottle of 90 Tablets Montelukast Sodium Chewable Tablets, USP The 4 mg (base) tablets are supplied as pink, speckled, oval, biconvex tablets with product identification “54” over “144” on one side and plain on the other side. NDC 0054-0288-13: Bottle of 30 Tablets NDC 0054-0288-22: Bottle of 90 Tablets The 5 mg (base) tablets are supplied as pink, speckled, round, biconvex tablets with product identification “54” over “741” on one side and plain on the other side. NDC 0054-0289-13: Bottle of 30 Tablets NDC 0054-0289-22: Bottle of 90 Tablets Storage Store Montelukast Sodium Tablets, USP and Montelukast Sodium Chewable Tablets, USP at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture and light. Store in original package.
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