montelukast 10 mg
1 INDICATIONS AND 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). 1.1 Asthma Montelukast sodium tablets are indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric 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 tablets are indicated for the relief of symptoms of seasonal allergic rhinitis in patients 15 years of age and older and perennial allergic rhinitis in patients of age and older. Because the benefits of montelukast sodium tablets may not outweigh the risk of neuropsychiatric symptoms in patients with reserve use for patients who have an inadequate response or intolerance to alternative therapies. Montelukast sodium tablets are 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.
Camber Pharmaceuticals, Inc.
SQUARE BROWN 114 I
114 I SQUARE BROWN
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16 HOW SUPPLIED/STORAGE AND HANDLING
MONTELUKAST sodium tablets, USP 10 mg are beige, rounded square-shaped, film-coated tablets debossed with 'I' on one side and '114' on the other side. They are supplied as follows: Bottles of 30 Tablets NDC 31722-726-30 Bottles of 90 Tablets NDC 31722-726-90 Bottles of 100 Tablets NDC 31722-726-01 Bottles of 1000 Tablets NDC 31722-726-10 Blister Card of 10 Unit-Dose Tablets NDC 31722-726-31 Blister Pack of 100 (10x10) Unit-Dose Tablets NDC 31722-726-32 Storage Store at 20° to 25°C (68° to 77°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-resistance container.
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