montelukast sodium montelukast tablet
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) 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 adults and adolescents 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 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. 1.4 Limitations of Use Montelukast sodium tablets are not indicated for the treatment of an acute asthma attack.
amneal pharmaceuticals llc
ROUND BROWN A 73
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16 HOW SUPPLIED/STORAGE AND HANDLING
MONTELUKAST sodium tablets USP, 10 mg, are supplied as beige, round, biconvex, film-coated tablets, debossed with “A 73” on one side and plain on the other side. They are available as follows: Bottles of 30: NDC 65162-732-03 Bottles of 90: NDC 65162-732-09 Bottles of 1,000: NDC 65162-732-11 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. Storage for Bulk Bottles Store bottles of 1,000
MONTELUKAST sodium, USP 10 mg film-coated tablets 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 container. When product container is subdivided, repackage into a well-closed, light-resistant container.
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