21 CFR § 520.784 - Doxylamine.

---
identifier: "/us/cfr/t21/s520.784"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 520.784 - Doxylamine."
title_number: 21
title_name: "Food and Drugs"
section_number: "520.784"
section_name: "Doxylamine."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "E"
subchapter_name: "ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS"
part_number: "520"
part_name: "ORAL DOSAGE FORM NEW ANIMAL DRUGS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 360b."
regulatory_source: "40 FR 13838, Mar. 27, 1975, unless otherwise noted."
cfr_part: "520"
---


# 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]