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These highlights do not include all the information needed to use MONTELUKAST SODIUM TABLETS, CHEWABLE TABLETS AND ORAL GRANULES safely and effectively. See full prescribing information for MONTELUKAST SODIUM TABLETS, CHEWABLE TABLETS AND ORAL GRANULES. MONTELUKAST SODIUM tablets, for oral use MONTELUKAST SODIUM chewable tablets, for oral use MONTELUKAST SODIUM oral granules Initial U.S. Approval: 1998
Medication labelWhy this: Advisory · dailymed-prescription
Montelukast sodium tablets, chewable tablets and oral granules are indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 12 months of age and older. Montelukast sodium tablets and chewable tablets are indicated for prevention of exercise-induced bronchoconstriction (EIB) in patients 6 years of age and older. Montelukast sodium tablets, chewable tablets and oral granules 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 6 months of age and older. Because the benefits of montelukast sodium tablets, chewable tablets and oral granules 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. Montelukast sodium tablets, chewable tablets and oral granules are not indicated for the treatment of an acute asthma attack.
- generic_name
- montelukast
- product_names
- MONTELUKAST
- ndc
- 63629-8235, 27241-017, 63629-8235-1
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en