{"data":{"id":"us/21-cfr-516.498","jurisdiction":"us","citation":"21 CFR 516.498","heading":"Crofelemer.","body":"(a) Specifications. Each delayed-release tablet contains 125 milligrams (mg) crofelemer.\n(b) Sponsor. See No. 086149 in § 510.600(c) of this chapter.\n(c) Conditions of use—(1) Amount. Administer 1 tablet orally twice daily for 3 days for dogs weighing ≤140 pounds. Administer 2 tablets orally twice daily for 3 days for dogs weighing \u003e140 pounds.\n(2) Indications for use. For the treatment of chemotherapy-induced diarrhea in dogs.\n(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. It is a violation of Federal law to use this product other than as directed in the labeling.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER E—ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS","PART 516—NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES","Subpart E—Conditionally Approved New Animal Drugs For Minor Use and Minor Species"],"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":"a319b247b580d0b365b2c1d521135609aee26f43587572b9f420eb2f73cce688","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-516.171","next":"us/21-cfr-516.570"},"notice":"GroundRules: Original legal text. Not legal advice."}