# Drug Labeling; Sodium Labeling for Over-the-Counter Drugs
> **Food and Drug Administration** · Final rule. · Published 2004-11-29 · Effective 2005-11-29 · 69 FR 69278
## Document
- **Document number:** 04-26269
- **Category:** fda-drug
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 69 FR 69278
- **CFR reference:** 21 CFR 201
- **Publication date:** 2004-11-29
- **Effective date:** 2005-11-29
- **HHS docket:** Docket No. 1990N-0309
## 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.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2004/11/29/04-26269/drug-labeling-sodium-labeling-for-over-the-counter-drugs)
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