CFR - Code of Federal Regulations Title 21

The information on this page is current as of Dec 22, 2023.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

[Code of Federal Regulations]

[Title 21, Volume 6]

[CITE: 21CFR520.1409]

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

Sec. 520.1409 Methylprednisolone and aspirin.

(a) Specifications. Each tablet contains 0.5 milligram of methylprednisolone and 300 milligrams of aspirin.

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

(c) Conditions of use in dogs - (1) Amount. Under 15 pounds, 1/4 to 1 tablet daily; 15 to 60 pounds, 1 to 2 tablets daily; 60 pounds and over, 2 tablets daily. Administer total daily dose in divided doses 6 to 10 hours apart, with a light feeding. When response is attained, dosage should be gradually reduced until maintenance level is achieved.

(2) Indications for use. As an anti-inflammatory and analgesic agent.

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

[48 FR 21566, May 13, 1983, as amended at 78 FR 28824, May 20, 2014]