CFR > 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 (parts 500 to 590) > PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS > 520.1920—Prochlorperazine, isopropamide sustained release capsules.

520.1920—Prochlorperazine, isopropamide sustained release capsules.

(a) Specifications. Prochlorperazine, isopropamide sustained release capsules contain 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. 000069 in § 510.600(c) of this chapter.
(c) Conditions of use. (1) The drug is used for the treatment of dogs in which gastrointestinal disturbances are associated with emotional stress.
(2) (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.
(3) For use only by or on the order of a licensed veterinarian.

Code of Federal Regulations

[40 FR 13838, Mar. 27, 1975, as amended at 56 FR 50653, Oct. 8, 1991; 60 FR 55659, Nov. 2, 1995]