---
kind: "section"
citation: "21 C.F.R. § 516.498"
title: "21"
number: "516.498"
heading: "Crofelemer."
url: "https://uscodex.org/cfr/21/516.498"
---

# §516.498. Crofelemer.

- (a) **Specifications.** Each delayed-release tablet contains 125 milligrams (mg) crofelemer.
- (b) **Sponsor.** See No. 086149 in [§ 510.600(c)](/cfr/21/510.600.md?p=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.

## Notes

### 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]