StacksVerified U.S. regulatory reference

21 CFR §640.84

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
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:
  1. (a)The osmotic equivalent in terms of plasma, and the sodium concentration in terms of a value or a range in milliequivalents per liter;
  2. (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.”;
  3. (c)The need for additional fluids when 20 percent or 25 percent albumin is administered to a patient with marked dehydration;
  4. (d)The protein concentration, expressed as a 4 percent, 5 percent, 20 percent, or 25 percent solution.