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Label Changes for:

Singulair (montelukast sodium) tablets, chewable tables and oral granules

January 2009

Changes have been made to the ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- January 2009


The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary.

Summary View


  • Post-Marketing Experience
    • epistaxis added


  • Less Common Side Effects
    • nosebleed, palpitations