![]() |
Code of Federal Regulations (Last Updated: July 5, 2024) |
![]() |
Title 21 - Food and Drugs |
![]() |
Chapter I - Food and Drug Administration, Department of Health and Human Services |
![]() |
SubChapter E - Animal Drugs, Feeds, and Related Products |
![]() |
Part 516 - New Animal Drugs for Minor Use and Minor Species |
![]() |
Subpart E - Conditionally Approved New Animal Drugs For Minor Use and Minor Species |
§ 516.498 - Crofelemer.
Latest version.
-
§ 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 ≤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]