21 CFR § 520.1468 - Naproxen.

---
identifier: "/us/cfr/t21/s520.1468"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 520.1468 - Naproxen."
title_number: 21
title_name: "Food and Drugs"
section_number: "520.1468"
section_name: "Naproxen."
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: "520"
part_name: "ORAL DOSAGE FORM NEW ANIMAL DRUGS"
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. 360b."
regulatory_source: "40 FR 13838, Mar. 27, 1975, unless otherwise noted."
cfr_part: "520"
---


# 520.1468 Naproxen.

(a) *Specifications.* Each gram of granules contains 500 milligrams (mg) (50 percent) naproxen.

(b) *Sponsor.* See No. 054771 in § 510.600(c) of this chapter.

(c) *Conditions of use in horses*—(1) *Amount.* 10 mg per kilogram of body weight twice daily top dressed on feed for up to 14 consecutive days.

(2) *Indications for use.* For the relief of inflammation and associated pain and lameness exhibited with arthritis, as well as myositis and other soft tissue diseases of the musculoskeletal system.

(3) *Limitations.* Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[78 FR 28825, May 20, 2014]