§520.1872. Praziquantel, pyrantel pamoate, and febantel tablets.
21 C.F.R. § 520.1872
Specifications. Each tablet or chewable tablet contains either:
Tablet No. 1: 22.7 milligrams praziquantel, 22.7 milligrams pyrantel base, and 113.4 milligrams febantel; or
Tablet No. 2: 68 milligrams praziquantel, 68 milligrams pyrantel base, and 340.2 milligrams febantel.
Tablet No. 3: 136 milligrams (mg) praziquantel, 136 mg pyrantel base, and 680.4 mg febantel.
Sponsor. See No. 058198 in § 510.600(c) of this chapter.
Conditions of use—
Dogs—
Amount. Administer as a single dose directly by mouth or in a small amount of food as follows:
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.
Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[Reserved]
Notes, amendments, and revision history
Amendments
[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]
Authority
Authority: 21 U.S.C. 360b.
Source
Source: 40 FR 13838, Mar. 27, 1975, unless otherwise noted.
Amendments
[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]