§ 516.498 Crofelemer.
Current through Sep 8, 2026 · Read all of Part 516
(a) Specifications. Each delayed-release tablet contains 125 milligrams (mg) crofelemer.
(b) Sponsor. See No. 086149 in § 510.600(c) of this chapter.
(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.
(2) Indications for use. For the treatment of chemotherapy-induced diarrhea in dogs.
(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.
[87 FR 17944, Mar. 29, 2022. Redesignated at 88 FR 16546, Mar. 20, 2023]