montelukast sodium granule montelukast sodium tablet chewable montelukast sodium montelukast tablet chewable montelukast sodium tablet coated
1 INDICATIONS AND USAGE Montelukast sodium tablets, chewable tablets, and oral granules are a leukotriene receptor antagonist indicated for: Prophylaxis and chronic treatment of asthma in patients 12 months 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 6 months 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, chewable tablets and oral granules are indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 12 months of age and older. 1.2 Exercise-Induced Bronchoconstriction (EIB) Montelukast sodium tablets and 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, chewable tablets and oral granules 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 6 months of age and older. Because the benefits of montelukast sodium tablets, chewable tablets and oral granules 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, chewable tablets and oral granules are not indicated for the treatment of an acute asthma attack.
ajanta pharma limited
ROUND WHITE M01
M01 ROUND WHITE
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16 HOW SUPPLIED/STORAGE AND HANDLING
MONTELUKAST SODIUM Oral Granules, USP 4 mg: white granules with 500 mg net weight, packed in a child-resistant foil sachet. NDC 27241-015-31 unit of use carton with 30 sachets.
MONTELUKAST SODIUM Chewable Tablets, USP 4 mg: pink colored, slightly mottled, circular, biconvex, uncoated tablets, with code 'MT1' engraved on one side and plain on the other side. NDC 27241-016-03 unit of use high-density polyethylene (HDPE) bottles of 30 with a polypropylene child-resistant cap, an aluminum foil induction seal, and silica gel canister. NDC 27241-016-09 unit of use high-density polyethylene (HDPE) bottles of 90 with a polypropylene child-resistant cap, an aluminum foil induction seal, and silica gel canister.
MONTELUKAST SODIUM Chewable Tablets, USP 5 mg: pink colored, slightly mottled, circular, biconvex, uncoated tablets, with code 'MT2' engraved on one side and plain on the other side. NDC 27241-017-03 unit of use high-density polyethylene (HDPE) bottles of 30 with a polypropylene child-resistant cap, an aluminum foil induction seal, and silica gel canister. NDC 27241-017-09 unit of use high-density polyethylene (HDPE) bottles of 90 with a polypropylene child-resistant cap, an aluminum foil induction seal, and silica gel canister.
MONTELUKAST SODIUM Tablets, USP 10 mg: beige colored, circular, biconvex, film-coated tablets with code 'MO1' engraved on one side and plain on the other side. NDC 27241-018-03 unit of use high-density polyethylene (HDPE) bottles of 30 with a polypropylene child-resistant cap, an aluminum foil induction seal, and silica gel canister. NDC 27241-018-09 unit of use high-density polyethylene (HDPE) bottles of 90 with a polypropylene child-resistant cap, an aluminum foil induction seal, and silica gel canister. NDC 27241-018-90 high-density polyethylene (HDPE) bottles of 1000 with a polypropylene continuous threaded cap, an aluminum foil induction seal, and silica gel canister. Storage Store
MONTELUKAST SODIUM 4-mg oral granules, 4-mg chewable tablets, 5-mg chewable tablets and 10-mg film-coated tablets at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from moisture and light. Store in original package.
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