21 C.F.R. § 520.1872
Praziquantel, pyrantel pamoate, and febantel tablets
(a) Specifications. Each tablet or chewable tablet contains either:
(1) Tablet No. 1: 22.7 milligrams praziquantel, 22.7 milligrams pyrantel base, and 113.4 milligrams febantel; or
(2) Tablet No. 2: 68 milligrams praziquantel, 68 milligrams pyrantel base, and 340.2 milligrams febantel.
(3) Tablet No. 3: 136 milligrams (mg) praziquantel, 136 mg pyrantel base, and 680.4 mg febantel.
(b) Sponsor. See No. 058198 in § 510.600(c) of this chapter.
(c) Conditions of use—(1) Dogs—(i) Amount. Administer as a single dose directly by mouth or in a small amount of food as follows:
| Weight of animal | Number of tablets per dose | |||
|---|---|---|---|---|
| Kilograms | Pounds | Tablet no. 1 | Tablet no. 2 | Tablet no. 3 |
| 0.9 to 1.8 | 2 to 4 | 1/2 | ||
| 2.3 to 3.2 | 5 to 7 | 1 | ||
| 3.6 to 5.4 | 8 to 12 | 1 1/2 | ||
| 5.9 to 8.2 | 13 to 18 | 2 | ||
| 8.6 to 11.4 | 19 to 25 | 2 1/2 | ||
| 11.8 to 13.6 | 26 to 30 | 1 | ||
| 14.1 to 20.0 | 31 to 44 | 1 1/2 | ||
| 20.4 to 27.2 | 45 to 60 | 2 | 1 | |
| 27.7 to 40.9 | 61 to 90 | 1 1/2 | ||
| 41.3 to 54.5 | 91 to 120 | 2 | ||
(ii) Indications for use. For the removal of tapeworms (Dipylidium caninum, Taenia pisiformis, Echinococcus granulosus); hookworms (Ancylostoma caninum, Uncinaria stenocephala); ascarids (Toxocara canis, Toxascaris leonina); and whipworms (Trichuris vulpis) and for the removal and control of tapeworm Echinococcus multilocularis in dogs.
(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) [Reserved]