Section 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.59 FR 33908, July 1, 1994, as amended at 61 FR 29651, June 12, 1996; 68 FR 22293, Apr. 28, 2003; 71 FR 6677, Feb. 9, 2006; 86 FR 14819, Mar. 19, 2021; 87 FR 58961, Sept. 29, 2022 86 FR 14819, 3/19/2021; 87 FR 58961, 9/29/2022