IMPORTANT PRODUCT INFORMATION:

SINGULAIR is indicated for prophylaxis and chronic treatment of asthma in patients aged 12 months and older.

SINGULAIR is indicated for relief of symptoms of allergic rhinitis (seasonal allergic rhinitis in adults and children aged 2 years and older and perennial allergic rhinitis in adults and children aged 6 months and older).

SINGULAIR is indicated for prevention of exercise-induced bronchoconstriction (EIB) in patients aged 15 years and older.

Important information:

SINGULAIR should not be used as rescue medication to treat acute asthma episodes. Patients should be advised to have appropriate rescue medication available.

Use of SINGULAIR may not eliminate the need for inhaled or systemic corticosteroids. Patients should not decrease the dose or stop taking any other anti-asthma medications unless instructed by a physician.

Safety and effectiveness of SINGULAIR in patients with asthma younger than 12 months have not been established.

Safety and effectiveness of SINGULAIR for EIB in patients younger than 15 years have not been established.

Patients already taking 1 tablet daily for another indication should not take an additional dose to prevent EIB. All patients should have available for rescue a short-acting β-agonist.

Chronic daily administration of SINGULAIR for other indications has not been established to prevent acute episodes of EIB.