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U.S. Department of Health and Human Services

Safety

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Delsym (dextromethorphan polistirex) Extended-Release Suspension, 30 mg/5 mL December 2008

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. Read about the new physician labeling format.


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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