montelukast sodium montelukast 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) Limitations of Use: Not indicated to treat an acute asthma attack. (5.2) 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 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. 1.4 Limitations of Use Montelukast sodium chewable tablets are not indicated for the treatment of an acute asthma attack.
amneal pharmaceuticals llc
OVAL PINK A71
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Amneal Pharmaceuticals NY LLC
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16 HOW SUPPLIED/STORAGE AND HANDLING
MONTELUKAST sodium chewable tablets USP, 4 mg, are supplied as pink, oval, biconvex tablets, debossed with “A 71” on one side and plain on the other side. They are available as follows: Bottles of 30: NDC 65162-771-03
MONTELUKAST sodium chewable tablets USP, 5 mg, are supplied as pink, round, biconvex tablets, debossed with “A 72” on one side and plain on the other side. They are available as follows: Bottles of 30: NDC 65162-772-03 Storage Store at 20° to 25°C (68° to 77°F), excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from moisture and light. Store in original package.
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