StacksVerified U.S. regulatory reference

21 CFR §516.498

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
  1. (a)Specifications. Each delayed-release tablet contains 125 milligrams (mg) crofelemer.
  2. (b)Sponsor. See No. 086149 in § 510.600(c) of this chapter.
  3. (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 >140 pounds.
    1. (2)Indications for use. For the treatment of chemotherapy-induced diarrhea in dogs.
    2. (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.