(a) Specifications. Each capsules contains either:

(1) 3.33 milligrams of prochlorperazine (as the dimaleate) and 1.67 milligrams of isopropamide (as the iodide); or

(2) 10 milligrams of prochlorperazine (as the dimaleate) and 5 milligrams of isopropamide (as the iodide).

(b) Sponsor. See No. 054771 in §510.600(c) of this chapter.

(c) Conditions of use in dogs—(1) Amount.

(i) Capsules described in paragraph (a)(1) of this section are administered orally to dogs weighing from 4 to 15 pounds at the rate of 1 capsule twice daily. These capsules are administered orally to dogs weighing from 16 to 30 pounds at the rate of 1 or 2 capsules twice daily. For dogs weighing less than 4 pounds, administer orally an appropriate fraction of the contents of one of these capsules.

(ii) Capsules described in paragraph (a)(2) of this section are given to dogs weighing 30 pounds and over at the rate of 1 capsule twice daily.

(2) Indications for use. For the treatment of gastrointestinal disturbances associated with emotional stress.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[79 FR 28827, May 20, 2014]