§516.498. Crofelemer.
21 C.F.R. § 516.498
Specifications. Each delayed-release tablet contains 125 milligrams (mg) crofelemer.
Sponsor. See No. 086149 in § 510.600(c) of this chapter.
Conditions of use—
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.
Indications for use. For the treatment of chemotherapy-induced diarrhea in dogs.
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.
Notes, amendments, and revision history
Amendments
[87 FR 17944, Mar. 29, 2022. Redesignated at 88 FR 16546, Mar. 20, 2023]
Source
Source: 72 FR 57200, Oct. 9, 2007, unless otherwise noted.
Authority
Authority: 21 U.S.C. 360ccc-1, 360ccc-2, 371.
Source
Source: 72 FR 41017, July 26, 2007, unless otherwise noted.
Amendments
[87 FR 17944, Mar. 29, 2022. Redesignated at 88 FR 16546, Mar. 20, 2023]