PMID- 19507324
OWN - HSR
STAT- MEDLINE
DCOM- 20090612
LR  - 20090609
IS  - 0097-6326 (Print)
IS  - 0097-6326 (Linking)
VI  - 74
IP  - 81
DP  - 2009 Apr 29
TI  - Organ-specific warnings; internal analgesic, antipyretic, and antirheumatic drug 
      products for over-the-counter human use; final monograph. Final rule.
PG  - 19385-409
AB  - 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).
CN  - Food and Drug Administration, HHS
LA  - eng
PT  - Journal Article
PL  - United States
TA  - Fed Regist
JT  - Federal register
JID - 7808722
RN  - 0 (Analgesics)
RN  - 0 (Analgesics, Non-Narcotic)
RN  - 0 (Antirheumatic Agents)
RN  - 0 (Nonprescription Drugs)
MH  - Analgesics/*adverse effects
MH  - Analgesics, Non-Narcotic/*adverse effects
MH  - Antirheumatic Agents/*adverse effects
MH  - Consumer Product Safety/legislation & jurisprudence
MH  - Drug Labeling/*legislation & jurisprudence
MH  - Humans
MH  - Legislation, Drug
MH  - Nonprescription Drugs/*adverse effects
MH  - United States
MH  - Viscera/*drug effects
EDAT- 2009/06/11 09:00
MHDA- 2009/06/13 09:00
CRDT- 2009/06/11 09:00
PHST- 2009/06/11 09:00 [entrez]
PHST- 2009/06/11 09:00 [pubmed]
PHST- 2009/06/13 09:00 [medline]
PST - ppublish
SO  - Fed Regist. 2009 Apr 29;74(81):19385-409.