{"data":{"id":"us/21-cfr-640.84","jurisdiction":"us","citation":"21 CFR 640.84","heading":"Labeling.","body":"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:\n(a) The osmotic equivalent in terms of plasma, and the sodium concentration in terms of a value or a range in milliequivalents per liter;\n(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.”;\n(c) The need for additional fluids when 20 percent or 25 percent albumin is administered to a patient with marked dehydration;\n(d) The protein concentration, expressed as a 4 percent, 5 percent, 20 percent, or 25 percent solution.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER F—BIOLOGICS","PART 640—ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS","Subpart H—Albumin (Human)"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"09b74a03c9c888a0957417dae1a1dc631498a169e25d3aca42791db480cbec12","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-640.83","next":"us/21-cfr-640.90"},"notice":"GroundRules: Original legal text. Not legal advice."}