CFR - Code of Federal Regulations Title 21

The information on this page is current as of Dec 22, 2023.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

[Code of Federal Regulations]

[Title 21, Volume 6]

[CITE: 21CFR520.1760]

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 520 -- ORAL DOSAGE FORM NEW ANIMAL DRUGS

Sec. 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 No. 055246 in § 510.600(c) of this chapter.

(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]