21 CFR 640.94
§ 640.94 Labeling.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 640.94, § 640.94 Labeling, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/88522
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Full text
In addition to the labeling requirements of §§ 610.60, 610.61, and 610.62 of this chapter, the container and package labels shall contain the following information:
(a) The osmotic equivalent in terms of plasma, and the sodium concentration in terms of a value or a range in milliequivalents per liter.
(b) The cautionary statement placed in a prominent position on the label, “Do Not Use if Turbid. Do Not Begin Administration More than 4 Hours After the Container Has Been Entered.”
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.