|
(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]
[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]
| 
