§ 520.1760 Phenylpropanolamine.
Primary source
Verbatim text below is from the Electronic Code of Federal Regulations (eCFR), a public-domain U.S. government work. Always verify the current version with the eCFR before relying on it for any legal matter.
Full Text
(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]
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