21 CFR §520.1150

1. (a)Specifications. Each tablet contains 100 or 400 milligrams (mg) imepitoin.
2. (b)Sponsor. See No. 000010 in § 510.600(c) of this chapter.
3. (c)Conditions of use—(1) Amount. Administer orally twice daily, approximately 12 hours apart, at a dose of 13.6 mg per pound (30 mg/kg) of body weight. Initiate therapy starting 2 days prior to the day of the expected noise event and continuing through the noise event.
   1. (2)Indications for use. For the treatment of noise aversion in dogs.
   2. (3)Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.