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Label Changes for:

NeoProfen (ibuprofen lysine) Injection

September 2008

Changes have been made to the ADVERSE REACTIONS sections of the safety label.

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


  • Postmarketing Experience (new subsection)
    • The following adverse reactions have been identified from spontaneous postmarketing reports or published literature: gastrointestinal perforation and necrotizing enterocolitis...

Label approved 09/12/2008 is not available on this site