FDA label
What is Singulair used for?
Singulair contains montelukast. The FDA-approved uses below are quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label for Singulair lists 3 uses: Asthma; Exercise-Induced Bronchoconstriction (EIB); Allergic Rhinitis.
Run it in Rivvi
Which 2027 plans near you dropped or restricted Singulair?
Tier changes and new prior auth, step therapy or quantity limits, plan by plan.
Free to start. Opens Rivvi, the AI workspace for healthcare teams.
Singulair, tablet, chewable
Indications and Usage, quoted from the label by Organon LLC (NDA020830). Cross-references to other label sections are left out.
Asthma
SINGULAIR® is indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 12 months of age and older.
Exercise-Induced Bronchoconstriction (EIB)
SINGULAIR is indicated for prevention of exercise-induced bronchoconstriction (EIB) in patients 6 years of age and older.
Allergic Rhinitis
SINGULAIR 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 SINGULAIR may not outweigh the risk of neuropsychiatric symptoms in patients with allergic rhinitis, reserve use for patients who have an inadequate response or intolerance to alternative therapies.
Limitations of Use
SINGULAIR is not indicated for the treatment of an acute asthma attack.
Source: DailyMed label, set id 482dcc92-b47f-4ea6-854a-f5ac2aea7842, version 5, effective April 30, 2025. NDC 78206-170, one of 2 listings for this product.
Questions
What is Singulair used for?
The FDA label for Singulair lists 3 uses: Asthma; Exercise-Induced Bronchoconstriction (EIB); Allergic Rhinitis.
What drug class is Singulair?
FDA lists montelukast in the Leukotriene Receptor Antagonist established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.
More on Singulair
- Is Singulair a controlled substance?Federal schedule
- Generic for SingulairFDA Orange Book
- What is Montelukast used for?FDA label uses
- Is Montelukast a controlled substance?Federal schedule
- Leukotriene Receptor Antagonists listFDA drug class
- NDC 78206-170Singulair NDC record
- NDC 78206-171Singulair NDC record
- NDC 78206-172Singulair NDC record