Crofelemer.

21 C.F.R. § 516.498
in effectEffective: 2024-07-01
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(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.

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