Healthy Skepticism Library item: 1643

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Publication type: Journal Article

Food and Drug Administration, HHS.
Drug labeling; sodium labeling for over-the-counter drugs.
Federal Register 2004 Nov 29; 69:(228):
http://a257.g.akamaitech.net/7/257/2422/06jun20041800/edocket.access.gpo.gov/2004/pdf/04-26269.pdf

Abstract:

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.

Keywords:
Administration, Rectal Cathartics/adverse effects Drug Labeling/legislation & jurisprudence* Drugs, Non-Prescription/adverse effects* Enema/adverse effects Humans Phosphates/administration & dosage Phosphates/adverse effects Sodium/administration & dosage Sodium/adverse effects* United States United States Food and Drug Administration Water-Electrolyte Balance/drug effects Cathartics Drugs, Non-Prescription Phosphates Sodium