Label Changes for:

Delsym (dextromethorphan polistirex) Extended-Release Suspension, 30 mg/5 mL

December 2008

Changes have been made to the WARNINGS sections of the safety label.

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

Summary of Changes to Contraindications and Warnings

WARNINGS

  • Drug Facts

WARNINGS

  • Directions were revised from “Children under 2 years of age: consult a doctor” to “Children under 4 years of age: do not use”

The latest label (approved 12/05/2008) is not available on this site

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