Organ-specific warnings; internal analgesic, antipyretic, and antirheumatic drug products for over-the-counter human use; final monograph. Final rule

Fed Regist. 2009 Apr 29;74(81):19385-409.


The Food and Drug Administration (FDA) is issuing this final rule to require important new organ-specific warnings and related labeling for over-the-counter (OTC) internal analgesic, antipyretic, and antirheumatic (IAAA) drug products. The new labeling informs consumers about the risk of liver injury when using acetaminophen and the risk of stomach bleeding when using nonsteroidal anti-inflammatory drugs (NSAIDS). The new labeling is required for all OTC IAAA drug products whether marketed under an OTC drug monograph or an approved new drug application (NDA).

MeSH terms

  • Analgesics / adverse effects*
  • Analgesics, Non-Narcotic / adverse effects*
  • Antirheumatic Agents / adverse effects*
  • Consumer Product Safety / legislation & jurisprudence
  • Drug Labeling / legislation & jurisprudence*
  • Humans
  • Legislation, Drug
  • Nonprescription Drugs / adverse effects*
  • United States
  • Viscera / drug effects*


  • Analgesics
  • Analgesics, Non-Narcotic
  • Antirheumatic Agents
  • Nonprescription Drugs