Singulair (montelukast sodium) Tablets, Chewable Tablets, and Oral Granules

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- March 2008

 

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

Sections Modified

ADVERSE REACTIONS

• Postmarketing Experience
  • Erythema Nodosum
  • Suicidal Thinking and Behavior (Suicidality)