Drug Labeling; Sodium Labeling for Over-the-Counter Drugs; Technical Amendment; Termination of Delay of Effective Date; Compliance Dates
fda-drug · Food and Drug Administration · Rule · Published 2004-03-24 · Effective 1996-04-22 · 69 FR 13717
Document
Document number
04-6479
Federal Register citation
69 FR 13717
CFR reference
21 CFR 201
Type
Rule
Action
Final rule; technical amendment; termination of delay of effective date; compliance dates.
Category
fda-drug
Sub-agency
Food and Drug Administration
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.