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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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[Code of Federal Regulations]
[Title 21, Volume 6]
[CITE: 21CFR520.2046]



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. 520.2046 Pyrantel tartrate pellets.

(a) Specifications. (1) Each gram of pellets contains 12.5 milligrams (mg) (1.25 percent) pyrantel tartrate; or

(2) Each gram of pellets contains 21.1 mg (2.11 percent) pyrantel tartrate.

(b) Sponsors. See sponsor numbers in § 510.600(c) of this chapter:

(1) No. 054771 for use of products described in paragraph (a) as in paragraph (c) of this section.

(2) No. 061133 for use of product described in paragraph (a)(1) as in paragraph (c) of this section.

(c) Conditions of use in horses - (1) Amount. Administer as a single dose at 12.5 mg per 2.2 pounds of body weight mixed with the usual grain ration.

(2) Indications for use. For the removal and control of infections from the following mature parasites: Large strongyles (Strongylus vulgaris, S. edentatus, S. equinus ), small strongyles (Trichonema spp., Triodontophorus ), pinworms (Oxyuris ), and large roundworms (Parascaris ).

(3) Limitations. Do not treat severely debilitated animals with this drug. Do not use in horses intended for human consumption.

[79 FR 28828, May 20, 2014, as amended at 84 FR 8973, Mar. 13, 2019]

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