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Code · CFR · Title 21 — Food and Drugs · Part 516 — New Animal Drugs for Minor Use and Minor Species · § 516.498

§ 516.498. Crofelemer.

116 words·~1 min read·/us/cfr/t21/s§ 516.498·

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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. [87 FR 17944, Mar. 29, 2022. Redesignated at 88 FR 16546, Mar. 20, 2023]
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