CFR - Code of Federal Regulations Title 21

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

[Code of Federal Regulations]

[Title 21, Volume 6]

[CITE: 21CFR520.2041]

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. 520.2041 Pyrantel pamoate chewable tablets.

(a) Specifications. Each tablet contains pyrantel pamoate equivalent to 22.7 or 113.5 milligrams pyrantel base.

(b) Sponsor. See Nos. 017135 and 051311 in § 510.600(c) of this chapter.

(c) Conditions of use - (1) Amount. Provides at least 2.27 milligrams pyrantel base per pound body weight for dogs weighing more than 5 pounds, and at least 4.54 milligrams of pyrantel base per pound body weight for dogs weighing 5 pounds or less.

(2) Indications for use - (i) In dogs and puppies. For removal of ascarids (Toxocara canis; Toxascaris leonina ) and hookworms (Ancylostoma caninum; Uncinaria stenocephala ).

(ii) In puppies and adult dogs and in lactating bitches after whelping. To prevent reinfection of Toxocara canis.

(3) Limitations. Administer to puppies at 2, 3, 4, 6, 8, and 10 weeks of age. Administer to lactating bitches 2 to 3 weeks after whelping. Retreatment of adult dogs may be necessary at monthly intervals as determined by laboratory fecal examinations. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.

[52 FR 37937, Oct. 13, 1987, as amended at 57 FR 48163, Oct. 22, 1992; 58 FR 44611, Aug. 24, 1993; 66 FR 9650, Feb. 9, 2001; 67 FR 21996, May 2, 2002; 81 FR 22523, Apr. 18, 2016; 82 FR 12169, Mar. 1, 2017; 84 FR 8973, Mar. 13, 2019]