Federal regulations · Through 2026-08-25 · Newer source version available

21 CFR 520.304: Carprofen.

(a) Specifications. (1) Each caplet contains 25, 75, or 100 milligrams (mg) carprofen.
(2) Each chewable tablet contains 25, 75, or 100 mg carprofen.
(3) Each chewable tablet contains 25, 37.5, 50, 75, or 100 mg carprofen.
(4) Each flavored tablet contains 25, 75, or 100 mg carprofen.
(b) Sponsors. See sponsors in § 510.600(c) of this chapter for use as in paragraph (c) of this section.
(1) Nos. 054771, 055529, and 082983 for use of products described in paragraphs (a)(1) and (a)(2) of this section as in paragraph (c) of this section.
(2) Nos. 058198, 086101 and 086117 for use of product described in paragraph (a)(2) as in paragraph (c) of this section.
(3) No. 069043 for use of product described in paragraph (a)(3) of this section as in paragraph (c) of this section.
(4) No. 086101 for use of product described in paragraphs (a)(1), (a)(2), and (a)(4) of this section as in paragraph (c) of this section.
(c) Conditions of use in dogs—(1) Amount. 2 mg per pound (/lb) of body weight once daily or 1 mg/lb twice daily. For the control of postoperative pain, administer approximately 2 hours before the procedure.
(2) Indications for use. For the relief of pain and inflammation associated with osteoarthritis and for the control of postoperative pain associated with soft tissue and orthopedic surgeries.
(3) Limitations. Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

Where this section sits in the code

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 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS

(a) Specifications. (1) Each caplet contains 25, 75, or 100 milligrams (mg) carprofen.

(2) Each chewable tablet contains 25, 75, or 100 mg carprofen.

(3) Each chewable tablet contains 25, 37.5, 50, 75, or 100 mg carprofen.

(4) Each flavored tablet contains 25, 75, or 100 mg carprofen.

(b) Sponsors. See sponsors in § 510.600(c) of this chapter for use as in paragraph (c) of this section.

(1) Nos. 054771, 055529, and 082983 for use of products described in paragraphs (a)(1) and (a)(2) of this section as in paragraph (c) of this section.

(2) Nos. 058198, 086101 and 086117 for use of product described in paragraph (a)(2) as in paragraph (c) of this section.

(3) No. 069043 for use of product described in paragraph (a)(3) of this section as in paragraph (c) of this section.

(4) No. 086101 for use of product described in paragraphs (a)(1), (a)(2), and (a)(4) of this section as in paragraph (c) of this section.

(c) Conditions of use in dogs—(1) Amount. 2 mg per pound (/lb) of body weight once daily or 1 mg/lb twice daily. For the control of postoperative pain, administer approximately 2 hours before the procedure.

(2) Indications for use. For the relief of pain and inflammation associated with osteoarthritis and for the control of postoperative pain associated with soft tissue and orthopedic surgeries.

(3) Limitations. Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

Collected 2026-08-27T02:24:47Z. Source file · JSON

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