montelukast 10 MG Oral Tablet
1 INDICATIONS AND USAGE Montelukast sodium tablets 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 ( 1.3 ). 1.1 Asthma Montelukast sodium tablets 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 are indicated for prevention of exercise-induced bronchoconstriction (EIB) in patients 6 years of age and older. 1.3 allergic rhinitis Montelukast sodium 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 6 months of age and older.
Apotex Corp
SQUARE BROWN APO M10
APO M10 SQUARE BROWN
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16 HOW SUPPLIED/STORAGE AND HANDLING Montelukast sodium chewable tablets, USP 4 mg, are pink, oval, biconvex chewable tablets, engraved with "APO" on one side and "M4" on the other side. The tablets may be mottled. They are supplied as follows: NDC 60505-3573-3 unit of use high-density polyethylene (HDPE) bottles of 30 with a polypropylene child-resistant cap with a triseal liner, a lift and peel induction seal, and silica gel desiccant NDC 60505-3573-9 unit of use high-density polyethylene (HDPE) bottles of 90 with a polypropylene child-resistant cap with a triseal liner, a lift and peel induction seal, and silica gel desiccant NDC 60505-3573-8 bulk packaging high-density polyethylene (HDPE) bottles of 1,000 with a non-child-resistant polypropylene cap with a triseal liner, a lift and peel induction seal, and silica gel desiccant. Montelukast sodium chewable tablets, USP 5 mg, are pink, round, biconvex chewable tablets, engraved with "APO" on one side and "M5" on the other side. The tablets may be mottled. They are supplied as follows: NDC 60505-3574-3 unit of use high-density polyethylene (HDPE) bottles of 30 with a polypropylene child-resistant cap with a triseal liner, a lift and peel induction seal, and silica gel desiccant NDC 60505-3574-9 unit of use high-density polyethylene (HDPE) bottles of 90 with a polypropylene child-resistant cap with a triseal liner, a lift and peel induction seal, and silica gel desiccant NDC 60505-3574-8 bulk packaging high-density polyethylene (HDPE) bottles of 1,000, with a non-child-resistant polypropylene cap with a triseal liner, a lift and peel induction seal, and silica gel desiccant. Montelukast sodium film-coated tablets, USP 10 mg, are beige, rounded square-shaped, biconvex film-coated tablets, engraved with "APO" on one side and "M10" on the other side. They are supplied as follows: NDC 60505-3562-3 unit of use high-density polyethylene (HDPE) bottles of 30 with a polypropylene child-resistant cap with a triseal liner, a lift and peel induction seal, and silica gel desiccant NDC 60505-3562-9 unit of use high-density polyethylene (HDPE) bottles of 90 with a polypropylene child-resistant cap with a triseal liner, a lift and peel induction seal, and silica gel desiccant NDC 60505-3562-8 bulk packaging high-density polyethylene (HDPE) bottles of 1,000, non-child-resistant polypropylene cap with a triseal liner, a lift and peel induction seal and silica gel desiccant. Storage Store montelukast 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 from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from moisture and light. Store in original package. Storage for Bulk Bottles Store bottles of 1,000 montelukast 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 from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from moisture and light. Store in original container. When product container is subdivided, repackage into a well-closed, light-resistant container.
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