montelukast 10 MG as montelukast sodium 10.4 MG Oral Tablet
1 INDICATIONS AND USAGE Montelukast sodium is a leukotriene receptor antagonist indicated for: Prophylaxis and chronic treatment of asthma in patients 12 months 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 6 months 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 is indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 12 months of age and older. 1.2 Exercise-Induced Bronchoconstriction (EIB) Montelukast sodium is indicated for prevention of exercise-induced bronchoconstriction (EIB) in patients 6 years of age and older. 1.3 allergic rhinitis Montelukast sodium is indicated for the relief of symptoms of seasonal allergic rhinitis in patients 2 years of age and older and perennial allergic rhinitis in patients 6 months of age and older. Because the benefits of montelukast sodium 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.
torrent pharmaceuticals limited
ROUND BROWN 1081 10
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16 HOW SUPPLIED/STORAGE AND HANDLING
MONTELUKAST SODIUM oral granules USP, 4 mg, are white to off white granules with 500 mg net weight, packed in a child-resistant foil packet. They are supplied as follows: NDC 13668-531-11 unit packet NDC 13668-531-94 carton with 30 packets. For
MONTELUKAST SODIUM film-coated tablets 10 mg The tablets are available as follow:
MONTELUKAST SODIUM tablets USP, 10 mg, are light brown colored, round, biconvex film coated tablets debossed with "1081" on one side and "10 MG" on other side. They are supplied as follows: Bottles of 30 NDC 13668-081-30 Bottles of 90 NDC 13668-081-90 Bottles of 500 NDC 13668-081-05 Bottles of 3,200 NDC 13668-081-32 For
MONTELUKAST SODIUM chewable tablets USP 4 mg and 5 mg The tablets are available as follow:
MONTELUKAST SODIUM chewable tablets USP, 4 mg, are pink colored, oval biconvex shaped, uncoated tablets, debossed with '1079' on one side and '4 MG' on other side. They are supplied as follows: Bottles of 30 NDC 13668-079-30 Bottles of 90 NDC 13668-079-90 Bottles of 500 NDC 13668-079-05
MONTELUKAST SODIUM chewable tablets USP, 5 mg, are pink colored, round shaped, uncoated tablets, debossed with '1080' on one side and '5 MG' on other side. They are supplied as follows: Bottles of 30 NDC 13668-080-30 Bottles of 90 NDC 13668-080-90 Bottles of 500 NDC 13668-080-05 Storage Store
MONTELUKAST SODIUM 4-mg oral granules,
MONTELUKAST SODIUM 4-mg chewable tablets, 5-mg chewable tablets and 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.
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