---
kind: "section"
citation: "21 C.F.R. § 520.1760"
title: "21"
number: "520.1760"
heading: "Phenylpropanolamine."
url: "https://uscodex.org/cfr/21/520.1760"
---

# §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)](/cfr/21/510.600.md?p=c) of this chapter for use as in [paragraph (c)](#c) of this section:
  - (1) **Nos.** 055246 and 086117 for use of product described in [paragraph (a)(1)](#a-1) of this section as in paragraphs [(c)(1)(i)](#c-1-i) and (c)(2) and (3) of this section.
  - (2) **No.** 055246 for use of product described in [paragraph (a)(2)](#a-2) of this section as in paragraph [(c)(1)(ii)](#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.

## Notes

### Amendments

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

### Authority

Authority: 21 U.S.C. 360b.

### Source

Source: 40 FR 13838, Mar. 27, 1975, unless otherwise noted.

### Amendments

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