Drug labeling; sodium labeling for over-the-counter drugs. Final rule.
The Food and Drug Administration (FDA) is issuing a final rule amending the regulations for sodium labeling for over-the-counter (OTC) drug products by extending the sodium content labeling requirement to rectal drug products containing sodium phosphate/sodium biphosphate (sodium phosphates). FDA is taking this action because people with certain medical conditions are at risk for an electrolyte imbalance to occur when using rectal sodium phosphates products. Serious adverse events and deaths have occurred because of the high level of sodium present in these products. This final rule is part of FDA's ongoing review of OTC drug products.
D000285:Administration, Rectal; D002400:Cathartics / Q000009:adverse effects; D004348:Drug Labeling / Q000331:legislation & jurisprudence*; D004733:Enema / Q000009:adverse effects; D006801:Humans; D004366:Nonprescription Drugs / Q000009:adverse effects*; D010710:Phosphates / Q000008:administration & dosage / Q000009:adverse effects; D012964:Sodium / Q000008:administration & dosage / Q000009:adverse effects*; D014481:United States; D014486:United States Food and Drug Administration; D014882:Water-Electrolyte Balance / Q000187:drug effects
D002400:Cathartics; D004366:Nonprescription Drugs; D010710:Phosphates; D012964:Sodium