21 CFR 516.498
§ 516.498 Crofelemer.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 516.498, § 516.498 Crofelemer, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/87046
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Full text
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.