montelukast sodium tablet chewable
1 INDICATIONS AND USAGE Montelukast sodium chewable tablets are 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 chewable tablets are 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 chewable tablets are indicated for prevention of exercise-induced bronchoconstriction (EIB) in patients 6 years of age and older. 1.3 allergic rhinitis sodium chewable 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 2 of age and older. Because the benefits of montelukast sodium chewable tablets may not outweigh the risk of neuropsychiatric symptoms in patients with allergic rhinitis , use for patients who have an inadequate response or intolerance to alternative therapies. Montelukast sodium chewable 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 2 years of age and older. Because the benefits of montelukast sodium chewable 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.
OVAL PINK I 112
I 112 OVAL PINK
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16 HOW SUPPLIED/STORAGE AND HANDLING
MONTELUKAST SODIUM Chewable Tablets 4 mg are light pink to pink colored, speckled, oval, biconvex shaped, chewable tablets debossed with 'I' on one side and '112' on the other side. They are supplied as follows: Bottles of 30 tablets NDC 31722-727-30 Bottles of 90 tablets NDC 31722-727-90 Bottles of 100 tablets NDC 31722-727-01 Bottles of 1000 tablets NDC 31722-727-10 Blister card of 10 Unit-dose tablets NDC 31722-727-31 Blister pack of 100 (10 x 10) Unit-dose tablets NDC 31722-727-32
MONTELUKAST SODIUM Chewable Tablets 5 mg are light pink to pink colored, speckled, round, biconvex shaped, chewable tablets debossed with 'I' on one side and '113' on the other side. Bottles of 30 tablets NDC 31722-728-30 Bottles of 90 tablets NDC 31722-728-90 Bottles of 100 tablets NDC 31722-728-01 Bottles of 1000 tablets NDC 31722-728-10 Blister card of 10 Unit-dose tablets NDC 31722-728-31 Blister pack of 100 (10 x 10) Unit-dose tablets NDC 31722-728-32 . 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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