montelukast 10 MG Oral Tablet
1 INDICATIONS & USAGE Montelukast sodium tablets are a leukotriene receptor antagonist indicated for: Prophylaxis and chronic treatment of asthma in patients 15 years of age and older ( 1.1 ). Acute prevention of exercise-induced bronchoconstriction (EIB) in patients 15 years of age and older ( 1.2 ). Relief of symptoms of allergic rhinitis (AR): seasonal allergic rhinitis (SAR) in patients 15 years of age and older, and perennial allergic rhinitis (PAR) in patients 15 years 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 are indicated for the prophylaxis and chronic treatment of asthma in patients 15 years of age and older. 1.2 Exercise-Induced Bronchoconstriction (EIB) Montelukast sodium tablets are indicated for prevention of exercise-induced bronchoconstriction (EIB) in patients 15 years of age and older. 1.3 allergic rhinitis Montelukast sodium is indicated for the relief of symptoms of seasonal allergic rhinitis in patients 15 years of age and older and perennial allergic rhinitis in patients 15 years of age and older. Because the benefits of montelukast sodium tablets 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 is not indicated for the treatment of an acute asthma attack.
Macleods Pharmaceuticals Limited
SQUARE ORANGE CL26
CL26 SQUARE ORANGE
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montelukast 10 MG Oral Tablet
Macleods Pharmaceuticals Limited
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16 HOW SUPPLIED/STORAGE AND HANDLING
MONTELUKAST sodium tablets, USP 10 mg are beige colour, rounded square shaped, biconvex, film-coated tablet debossed with 'CL 26' on one side and plain on the other side. They are supplied as follows: Bottles of 30 NDC 33342-102-07 Bottles of 90 NDC 33342-102-10 Bottles of 500s NDC 33342-102-15 Unit-dose blister pack of 90s NDC 33342-102-39 Unit-dose blister pack of 100s NDC 33342-102-12 Storage Store
MONTELUKAST sodium 10-mg film-coated tablets at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from moisture and light. Store in original package. Storage for Bulk Bottles Store bottles of 500
MONTELUKAST sodium 10-mg filmcoated tablets at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° 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. Preserve in tight containers, protected from light. Store at controlled room temperature.
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