Augmentin (amoxicillin/clavulanate potassium) Powder for Oral Suspension and Chewable Tablets 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

ADVERSE REACTIONS

• Hypersensitivity Reactions
  • hypersensitivity vasculitis
• Liver
  • ...hepatitis and cholestatic jaundice, (see CONTRAINDICATIONS)...