21 C.F.R. § 520.1872

Current through October 31, 2024
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 animalNumber of tablets per dose
Kilograms Pounds Tablet no. 1 Tablet no. 2 Tablet no. 3
0.9 to 1.82 to 41/2
2.3 to 3.25 to 71
3.6 to 5.48 to 121 1/2
5.9 to 8.213 to 182
8.6 to 11.419 to 252 1/2
11.8 to 13.626 to 301
14.1 to 20.031 to 441 1/2
20.4 to 27.245 to 6021
27.7 to 40.961 to 901 1/2
41.3 to 54.591 to 1202

(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]

21 C.F.R. §520.1872

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