21 CFR § 516.498 - Crofelemer.

---
identifier: "/us/cfr/t21/s516.498"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 516.498 - Crofelemer."
title_number: 21
title_name: "Food and Drugs"
section_number: "516.498"
section_name: "Crofelemer."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "E"
subchapter_name: "ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS"
part_number: "516"
part_name: "NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 360ccc-1, 360ccc-2, 371."
regulatory_source: "72 FR 41017, July 26, 2007, unless otherwise noted."
cfr_part: "516"
---


# 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. Redesignated at 88 FR 16546, Mar. 20, 2023]