§520.1870. Praziquantel tablets.
21 C.F.R. § 520.1870
Specifications.
Each tablet contains 34 milligrams (mg) praziquantel.
Each tablet contains 11.5 or 23 mg praziquantel.
Each chewable tablet contains 23 mg praziquantel.
Sponsors. See sponsors in § 510.600(c) of this chapter.
No. 058198 for use of product described in paragraph (a)(1) of this section as in paragraph (c)(1) of this section and for use of product described in paragraph (a)(2) of this section as in paragraph (c)(2) of this section.
Nos. 069043 and 086101 for use of product described in paragraph (a)(1) of this section as in paragraphs (c)(1) of this section.
No. 086101 for use of product as described in paragraph (a)(3) of this section as in paragraph (c)(2) of this section.
Conditions of use—
Dogs—
Amount. 5 pounds (lb) and under, 1/2 tablet (17 mg); 6 to 10 lb, 1 tablet (34 mg); 11 to 15 lb, 1 1/2 tablets (51 mg); 16 to 30 lb, 2 tablets (68 mg); 31 to 45 lb, 3 tablets (102 mg); 46 to 60 lb, 4 tablets (136 mg); over 60 lb, 5 tablets maximum (170 mg). Administer directly by mouth or crumbled and in feed.
Indications for use—
For removal of canine cestodes Dipylidium caninum and Taenia pisiformis.
For removal of the canine cestode Echinococcus granulosus, and for removal and control of the canine cestode Echinococcus multilocularis.
Limitations—
If labeled only for use as in paragraph (c)(1)(ii)(A) of this section: Not intended for use in puppies less than 4 weeks of age. Consult your veterinarian before administering tablets to weak or debilitated animals and for assistance in the diagnosis, treatment, and control of parasitism.
If labeled for use as in paragraph (c)(1)(ii)(B) of this section: Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Cats—
Indications for use. For removal of feline cestodes Dipylidium caninum and Taenia taeniaeformis.
Dosage. Cats 4 pounds and under, 11.5 mg; 5 to 11 pounds, 23 mg; over 11 pounds, 34.5 mg.
Limitations. Administer directly by mouth or crumbled and in feed. Not intended for use in kittens less than 6 weeks of age. For over the counter use: Consult your veterinarian before administering tablets to weak or debilitated animals, and for assistance in the diagnosis, treatment, and control of parasitism.
Notes, amendments, and revision history
Amendments
[46 FR 60570, Dec. 11, 1981, as amended at 47 FR 26377, June 18, 1982; 55 FR 2234, Jan. 23, 1990; 58 FR 7864, Feb. 10, 1993; 58 FR 42853, Aug. 12, 1993; 68 FR 57351, Oct. 3, 2003; 69 FR 62181, Oct. 25, 2004; 78 FR 17596, Mar. 22, 2013; 81 FR 17607, Mar. 30, 2016; 86 FR 14819, Mar. 19, 2021; 87 FR 58961, Sept. 29, 2022; 88 FR 27699, May 3, 2023; 91 FR 20342, Apr. 16, 2026]
Authority
Authority: 21 U.S.C. 360b.
Source
Source: 40 FR 13838, Mar. 27, 1975, unless otherwise noted.
Amendments
[46 FR 60570, Dec. 11, 1981, as amended at 47 FR 26377, June 18, 1982; 55 FR 2234, Jan. 23, 1990; 58 FR 7864, Feb. 10, 1993; 58 FR 42853, Aug. 12, 1993; 68 FR 57351, Oct. 3, 2003; 69 FR 62181, Oct. 25, 2004; 78 FR 17596, Mar. 22, 2013; 81 FR 17607, Mar. 30, 2016; 86 FR 14819, Mar. 19, 2021; 87 FR 58961, Sept. 29, 2022; 88 FR 27699, May 3, 2023; 91 FR 20342, Apr. 16, 2026]