21 CFR § 520.1760 - Phenylpropanolamine.

---
identifier: "/us/cfr/t21/s520.1760"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 520.1760 - Phenylpropanolamine."
title_number: 21
title_name: "Food and Drugs"
section_number: "520.1760"
section_name: "Phenylpropanolamine."
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"
---


# 520.1760 Phenylpropanolamine.

(a) *Specifications.* (1) Each chewable tablet contains 25, 50, or 75 milligram (mg) phenylpropanolamine hydrochloride.

(2) Each extended-release tablet contains 18, 38, 74, or 145 mg phenylpropanolamine hydrochloride.

(b) *Sponsors.* See sponsors in § 510.600(c) of this chapter for use as in paragraph (c) of this section:

(1) Nos. 055246 and 086117 for use of product described in paragraph (a)(1) of this section as in paragraphs (c)(1)(i) and (c)(2) and (3) of this section.

(2) No. 055246 for use of product described in paragraph (a)(2) of this section as in paragraph (c)(1)(ii) and (c)(2) and)(3) of this section.

(c) *Conditions of use in dogs*—(1) *Amount.* Administer orally as follows:

(i) Chewable tablet: 2 mg/kg of body weight twice daily.

(ii) Extended-release tablet: 2 to 4 mg/kg of body weight once daily with food.

(2) *Indications for use.* For the control of urinary incontinence due to urethral sphincter hypotonus in dogs.

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

[77 FR 15961, Mar. 19, 2012, as amended at 84 FR 39183, Aug. 9, 2019; 89 FR 85426, Oct. 28, 2024]