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U.S. Department of Health and Human Services

Safety

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Ponstel (mefenamic acid capsules, USP)


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

PRECAUTIONS

  • Information for Patients
    • In late pregnancy, as with other NSAIDs, Ponstel should be avoided because it may cause premature closure of the ductus arteriosus.

MEDICATION GUIDE

  • Table: NSAID that need a prescription - The following footnote was added after the table: *Vicoprofen contains the same dose of ibuprofen as over-the-counter (OTC) NSAIDs, usually used for less than 10 days to treat pain. The OTC NSAID label warns that long term continuous use may increase the risk of heart attack or stroke.

Contact Sciele Pharma, Inc. at 1-800-461-3696 for current prescribing information.