21 C.F.R. § 520.1921

Current through October 31, 2024
Section 520.1921 - Prochlorperazine, isopropamide, and neomycin
(a)Specifications. Each capsule contains either:
(1) Capsule No. 1: 3.33 milligrams of prochlorperazine (as the dimaleate), 1.67 milligrams of isopropamide (as the iodide), and 25 milligrams of neomycin base (as the sulfate); or
(2) Capsule No. 3: 10 milligrams of prochlorperazine (as the dimaleate), 5 milligrams of isopropamide (as the iodide), and 75 milligrams of neomycin base (as the sulfate).
(b)Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c)Conditions of use in dogs -
(1)Amount. Administer capsules orally twice daily to dogs as follows:

Animal weight (pounds)Number of capsules per dose
Capsule No. 1 Capsule No. 3
10 to 201
20 to 302
Over 3031
Over 602

(2)Indications for use. For the treatment infectious bacterial gastroenteritis associated with emotional stress.
(3)Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

21 C.F.R. §520.1921

49 FR 14103, Apr. 10, 1984, as amended at 56 FR 50653, Oct. 8, 1991; 60 FR 55659, Nov. 2, 1995; 79 FR 28827 , May 20, 2014