# Drug Labeling; Sodium Labeling for Over-the-Counter Drugs; Technical Amendment; Termination of Delay of Effective Date; Compliance Dates
> **Food and Drug Administration** · Final rule; technical amendment; termination of delay of effective date; compliance dates. · Published 2004-03-24 · Effective 1996-04-22 · 69 FR 13717
## Document
- **Document number:** 04-6479
- **Category:** fda-drug
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 69 FR 13717
- **CFR reference:** 21 CFR 201
- **Publication date:** 2004-03-24
- **Effective date:** 1996-04-22
- **HHS docket:** Docket No. 90N-0309
## Abstract

The Food and Drug Administration (FDA) is amending the regulation that established conditions under which the labeling of over-the-counter (OTC) drug products intended for oral ingestion must include the sodium content and a general warning that persons who are on a sodium restricted diet should not take the product unless directed by a doctor. This final rule makes a few minor labeling changes and broadens the conditions for using the descriptive term "sodium free." This document also terminates the delay of the effective date of the provisions concerning sodium labeling (Sec. 201.64(a) through (h)) and establishes compliance dates for the final rule.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2004/03/24/04-6479/drug-labeling-sodium-labeling-for-over-the-counter-drugs-technical-amendment-termination-of-delay-of)
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