Regulations last checked for updates: Nov 22, 2024

Title 21 - Food and Drugs last revised: Nov 19, 2024
§ 520.784 - Doxylamine.

(a) Specifications. The drug is in tablet form and contains doxylamine succinate as the active drug ingredient.

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

(c) Conditions of use—(1) Amount. Horses: Administer orally 1 to 2 milligrams (mg) per pound (/lb) of body weight per day divided into 3 or 4 equal doses. Dogs and cats: Administer orally 2 to 3 mg/lb of body weight per day divided into 3 or 4 equal doses.

(2) Indications for use. For use when 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.

[40 FR 13838, Mar. 27, 1975, as amended at 42 FR 60140, Nov. 25, 1977; 46 FR 48642, Oct. 2, 1981; 61 FR 8873, Mar. 6, 1996; 62 FR 61624, Nov. 19, 1997; 79 FR 28821, May 20, 2014]
authority: 21 U.S.C. 360b.
source: 40 FR 13838, Mar. 27, 1975, unless otherwise noted.
cite as: 21 CFR 520.784