Section 516.498 - Crofelemer(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 [LESS THAN EQUAL TO]140 pounds. Administer 2 tablets orally twice daily for 3 days for dogs weighing [GREATER THAN]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 87 FR 17944, 3/29/2022; Redesignated at 88 FR 16546, 3/20/2023