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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of Oct 01, 2021.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 6]
[CITE: 21CFR520.1872]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER E - ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS

PART 520 -- ORAL DOSAGE FORM NEW ANIMAL DRUGS

Sec. 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 animal Number 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 30 1
14.1 to 20.031 to 44 1 1/2
20.4 to 27.245 to 60 21
27.7 to 40.961 to 90 1 1/2
41.3 to 54.591 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. Do not use in pregnant animals. Do not use in dogs weighing less than 0.9 kilogram (2 pounds) or puppies less than 3 weeks of age. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[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]

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