Food and Drug Administration
Nonprescription Drugs Advisory Committee
September 19, 2002
Briefing Information
Index pdf
Section I: Overview and Federal Register Documents
Section I Index pdf
Overview of the September 19 and 20, 2002 NDAC Meeting pdf
Establishment of a Monograph for OTC Internal Analgesic, Antipyretic and Antirheumatic products (Panel Report or ANPR) pdf
Internal Analgesic, Antipyretic and Antirheumatic Products for over-The -Counter Human Use; Tentative Final Monograph pdf
Over-The-Counter Drug products Containing Analgesic/Antipyretic Active Ingredients for Internal Use; Required Alcohol Warning (Notice of Proposed Rulemaking) pdf
Over-The-Counter Drug products Containing Analgesic/Antipyretic Active Ingredients for Internal Use; Required Alcohol Warning (Final Rule) pdf
Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-The-Counter Human Use; Final Rule for Professional Labeling of Aspirin, Buffered Aspirin, and Aspirin in Combination with Antacid Drug Products pdf
Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-The- Counter Human Use; Proposed Amendment of the Tentative Final Monograph, and Related Labeling pdf
Section II: Acetaminophen Reviews
Section II Index pdf
Archeological Review of the Regulatory history of OTC Single Ingredient Acetaminophen pdf
History Supporting Documents pdf
Acetaminophen-PK/Metabolism pdf
Acetaminophen - Containing Products-Hepatotoxicity pdf
Acetaminophen - Utilization Data pdf
Acetaminophen - Epidemiology of Acetaminophen-related Overdose - National Mortality Data pdf
Review of Acetaminophen Poisoning Exposures in Toxic Exposure Surveillance System (TESS) pdf
Review of Adult and Adolescents Exposure Data on Acetaminophen-containing Products from Two Regional Poison Control Centers pdf
Acetaminophen Overdose Reference Articles pdf
Emerging Trends in Acute Liver Failure in U.S. - Abstract pdf
Section III: NSAID/Aspirin Reviews
Section III Index pdf
Literature Search Submitted in Preparation for the September 2002 NDAC Meeting pdf
Appendix I pdf
NSAID Renal Review pdf
Renal Toxicity References (6) pdf
Aspirin - GI Bleed pdf
NSAID - GI Bleed pdf
NSAID/ASA GI Bleed References (5) pdf
Section IV: Safety Reports
Acetaminophen (APAP) Safety Reports doc htm pdf
Acetaminophen (APAP) Safety Reports Index xls
Aspirin Safety Reports Index doc pdf
OTC Aspirin Safety Reports, Part I pdf
OTC Aspirin Safety Reports, Part II pdf
OTC Aspirin Safety Reports, Part III pdf
Ibuprophen Safety Reports Index doc pdf
OTC NSAID: Ibuprophen Safety Reports, Part I pdf
OTC NSAID: Ibuprophen Safety Reports, Part II pdf
Ketoprofen Safety Reports Index doc htm pdf
OTC NSAID: Ketoprofen Safety Reports pdf
Naproxen Safety Reports Index doc htm pdf
OTC NSAID: Naproxen Safety Reports, Part I pdf
OTC NSAID: Naproxen Safety Reports, Part II pdf
Industry Backgrounders
Acetaminophen, McNeil Consumer & Specialty Pharmaceuticals doc htm pdf
Monograph Analgesic Products, Bayer Consumer Care Division pdf
Safety Issues Related to the Use of Acetaminophen, Pfizer, Inc. pdf
American Association of Poison Control Centers (AAPCC) Toxic Exposure Surveillance System (TESS), The Procter & Gamble Co. doc htm pdf
Current OTC Analgesic Labeling pdf