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; technical amendments.  Department of Health and Human Services (HHS), Public Health Service (PHS), Food and Drug Administration (FDA).  Final rule; technical amendments.
The Food and Drug Administration (FDA) is amending the regulations for internal analgesic, antipyretic, and antirheumatic drug products for over-the-counter (OTC) use to correct inadvertent errors and to clarify the labeling for over-the-counter drug products written for health professionals.
D000818:Animals; D000863:Antacids; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects / Q000493:pharmacokinetics / Q000633:toxicity; D001241:Aspirin / Q000009:adverse effects / Q000493:pharmacokinetics / Q000633:toxicity; D000075202:Contraindications; D004338:Drug Combinations; D004348:Drug Labeling / Q000331:legislation & jurisprudence; D006801:Humans; D004366:Nonprescription Drugs; D051381:Rats; D014481:United States; D014486:United States Food and Drug Administration
D000863:Antacids; D000894:Anti-Inflammatory Agents, Non-Steroidal; D004338:Drug Combinations; D004366:Nonprescription Drugs; D001241:Aspirin