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U.S. Department of Health and Human Services

Safety

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Symmetrel (amantadine hydrochloride) Syrup and Tablets February 2009

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- February 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. Read about the new physician labeling format.


Summary View

Sections Modified

PRECAUTIONS

  • Melanoma
  • Information for Patients
    • ...urge to gamble....

ADVERSE REACTIONS

  • Miscellaneous section
    • addition of impulse control disorder

The latest approved label is not available on this site