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U.S. Department of Health and Human Services

Safety

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Resources for You

NegGram (nalidixic acid) Caplets March 2009

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

  • General subsection text modified
    • Caution should be used in patients with renal insufficiency (term "severe" & "failure" removed) and subsequent sentence removed