In addition to the labeling requirements of Sec. Sec. 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.'';
(c) The need for additional fluids when 20 percent or 25 percent albumin is administered to a patient with marked dehydration;
(d) The protein concentration, expressed as a 4 percent, 5 percent, 20 percent, or 25 percent solution. [42 FR 27582, May 31, 1977, as amended at 49 FR 2244, Jan. 19, 1984; 64 FR 26286, May 14, 1999]