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[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of April 1, 2008]
[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 ofToxocara 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]

Database Updated April 1, 2008

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