montelukast sodium tablet film coated montelukast sodium tablet chewable
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 ). 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.
teva pharmaceuticals usa, inc.
ROUND BROWN 93 7426
93 7426 ROUND BROWN
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16 HOW SUPPLIED/STORAGE AND HANDLING Montelukast Sodium Tablets USP are available as: 10 mg (montelukast) β beige, standard convex round, unscored, film-coated tablets, debossed with βTVβ on one side of the tablet and β7426β on the other side, in bottles of 30 (NDC 0093-7426-56), 90 (NDC 0093-7426-98), and 1000 (NDC 0093-7426-10). Montelukast Sodium Chewable Tablets USP are available as: 4 mg (montelukast) β mottled pink, arc triangle-shaped, unscored tablets, debossed with βTVβ on one side of the tablet and β7424βon the other side, in bottles of 30 (NDC 0093-7424-56) and 90 (NDC 0093-7424-98). 5 mg (montelukast) β mottled pink, square-shaped, unscored tablets, debossed with βTVβ on one side of the tablet and β7425β on the other side, in bottles of 30 (NDC 0093-7425-56) and 90 (NDC 0093-7425-98). Storage Store at 20Β° to 25Β°C (68Β° to 77Β°F) [See USP Controlled Room Temperature]. Protect from moisture and light. Store in original package. Storage for Bulk Bottles When product container is subdivided, repackage into a well-closed, light-resistant container. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
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