Montelukast Sodium
Merck Sharp & Dohme Corp., a subsidiary of Merck and Co., Inc.

PRESCRIBING INFORMATION

Prescribing Information
SINGULAIR® (MONTELUKAST SODIUM)
TABLETS, CHEWABLE TABLETS, AND ORAL GRANULES

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SINGULAIR is a prescription medicine used to prevent asthma attacks and for long-term treatment of asthma in adults and children 12 months and older.

IMPORTANT SAFETY INFORMATION

  • You or your child should not take SINGULAIR for relief right away from a sudden asthma attack. Always have your or your child's rescue inhaler medicine with you for asthma attacks. Tell your healthcare provider right away if your or your child's asthma symptoms get worse or if you need, or your child needs, to use rescue inhaler medicine more often for asthma attacks.
  • SINGULAIR may cause serious side effects. Behavior and mood-related changes have been reported: agitation including aggressive behavior or hostility, bad or vivid dreams, depression, disorientation (confusion), feeling anxious, hallucinations (seeing or hearing things that are not really there), irritability, restlessness, sleepwalking, suicidal thoughts and actions (including suicide), tremor, and trouble sleeping. Tell your healthcare provider right away if you have, or your child has, any of these symptoms while taking SINGULAIR.
  • The most common side effects with SINGULAIR include upper respiratory infection, fever, headache, sore throat, cough, stomach pain, diarrhea, earache or ear infection, flu, runny nose, and sinus infection.
  • SINGULAIR should not be taken by people who are sensitive to any of its ingredients.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please read the Patient Information and discuss it with your doctor. The physician Prescribing Information also is available.

SINGULAIR is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of  Merck & Co., Inc.
20852779(12)-06/10-SNG

 

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