CFR - Code of Federal Regulations Title 21

The information on this page is current as of Oct 17, 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: 21CFR522.784]

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 522 -- IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

Sec. 522.784 Doxylamine.

(a) Specifications. Each milliliter contains 11.36 milligrams (mg) of doxylamine succinate.

(b) Sponsor. See No. 000061 in § 510.600(c) of this chapter.

(c) Conditions of use - (1) Amount - (i) Horses: Administer 25 mg per hundred pounds of body weight by intramuscular, subcutaneous, or slow intravenous injection.

(ii) Dogs and cats: Administer 0.5 to 1 mg per pound of body weight by intramuscular or subcutaneous injection. Doses may be repeated at 8 to 12 hours, if necessary, to produce desired effect.

(2) Indications for use. For use in conditions in which antihistaminic therapy may be expected to alleviate some signs of disease in horses, dogs, and cats.

(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.

[79 FR 16187, Mar. 25, 2014]