21 CFR § 520.1921 - Prochlorperazine, isopropamide, and neomycin.

§ 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 20 1
20 to 30 2
Over 30 3 1
Over 60 2

(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.

[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]