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montelukast 10 MG as montelukast sodium 10.4 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 ). 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


10 years ago ROUND BROWN 7426 TV montelukast 10 MG as montelukast sodium 10.4 MG Oral Tablet

ROUND BROWN 7426 TV

10 years ago ROUND BROWN 7426 TV montelukast 10 MG as montelukast sodium 10.4 MG Oral Tablet

7426 TV ROUND BROWN

16 HOW SUPPLIED/STORAGE AND HANDLING Montelukast Sodium Tablets USP are available as: 10 mg (montelukast) – beige, standard convex round, unscored, film-coated tablets, debossed with β€œTV” on one side of the tablet and β€œ7426” 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) – mottled pink, arc triangle-shaped, unscored tablets, debossed with β€œTV” on one side of the tablet and β€œ7424”on the other side, in bottles of 30 (NDC 0093-7424-56) and 90 (NDC 0093-7424-98). 5 mg (montelukast) – mottled pink, square-shaped, unscored tablets, debossed with β€œTV” on one side of the tablet and β€œ7425” 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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