montelukast sodium tablet chewable montelukast sodium 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 PINK 1080 5 mg
1080 5 mg ROUND PINK
Related Pills
montelukast 10 MG as montelukast sodium 10.4 MG Oral Tablet
torrent pharmaceuticals limited
montelukast sodium tablet chewable montelukast sodium tablet
torrent pharmaceuticals limited
DISCLAIMER:
"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."
"Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service."
"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."
PillSync may earn a commission via links on our site
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 13668-531-11unit 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 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.
More pills like ROUND 1080 5 mg