21CFR520.1872

(a) Specifications. Each tablet or chewable tablet contains either: (b) Sponsor. See No. 058198 in § 510.600(c) of this chapter . (c) Conditions of use — [TABLE] 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 (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. (1) Dogs — [TABLE] 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 (i) Amount. Administer as a single dose directly by mouth or in a small amount of food as follows: [TABLE] 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]