GroundRules
21 CFR 522.784: Doxylamine.
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 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
(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.
Collected 2026-08-27T02:24:47Z. Source file · JSON