1 INDICATIONS AND USAGE SINGULAIR is 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 SINGULAIR ® is 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) SINGULAIR is indicated for prevention of exercise-induced bronchoconstriction (EIB) in patients 6 years of age and older. 1.3 Allergic Rhinitis SINGULAIR 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 6 months of age and older. Because the benefits of SINGULAIR 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 SINGULAIR is not indicated for the treatment of an acute asthma attack.
Merck Sharp & Dohme Corp.
SQUARE BROWN MRK 117 SINGULAIR
MRK 117 SINGULAIR SQUARE BROWN
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16 HOW SUPPLIED/STORAGE AND HANDLING SINGULAIR 4 mg Oral Granules: white granules with 500 mg net weight, packed in a child-resistant foil packet. NDC 0006-3841-30 unit of use carton with 30 packets. SINGULAIR 4 mg Tablets: pink, oval, bi-convex-shaped chewable tablets, with code MSD 711 on one side and SINGULAIR on the other. NDC 0006-1711-31 unit of use high-density polyethylene (HDPE) bottles of 30 with a polypropylene child-resistant cap, an aluminum foil induction seal, and silica gel desiccant. SINGULAIR 5 mg Tablets: pink, round, bi-convex-shaped chewable tablets, with code MSD 275 on one side and SINGULAIR on the other. NDC 0006-9275-31 unit of use high-density polyethylene (HDPE) bottles of 30 with a polypropylene child-resistant cap, an aluminum foil induction seal, and silica gel desiccant. SINGULAIR 10 mg Tablets: beige, rounded square-shaped, film-coated tablets, with code MSD 117 on one side and SINGULAIR on the other. NDC 0006-9117-31 unit of use high-density polyethylene (HDPE) bottles of 30 with a polypropylene child-resistant cap, an aluminum foil induction seal, and silica gel desiccant NDC 0006-9117-54 unit of use high-density polyethylene (HDPE) bottles of 90 with a polypropylene child-resistant cap, an aluminum foil induction seal, and silica gel desiccant. Storage Store SINGULAIR 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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