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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: 21CFR520.2045]



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. 520.2045 Pyrantel tartrate powder.

(a) Specifications. Each gram of powder contains 106 milligrams (10.6 percent) or 113 milligrams (11.3 percent) pyrantel tartrate.

(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter for use of 11.3 percent powder as in paragraph (d)(1) and 10.6 percent powder as in paragraph (d)(2) and of this section.

(c) Related tolerances. See § 556.560 of this chapter.

(d) Conditions of use - (1) Horses - (i) Amount. Administer as a single dose at 0.57 gram of pyrantel tartrate per 100 pounds of body weight mixed with the usual grain ration. Do not administer by stomach tube or dose syringe.

(ii) 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 ).

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

(2) Swine - (i) Amount. Add to feed at 0.4 gram pyrantel tartrate per pound of non-pelleted ration. The ration is administered as a single treatment as the sole ration at the rate of 1 pound per 40 pounds of animal weight for animals up to 200 pounds. Animals 200 pounds and over are administered 5 pounds of ration per animal.

(ii) Indications for use. For the removal and control of large roundworms (Ascaris suum ) and nodular worm (Oesophagostomum ) infections.

(iii) Limitations. Consult veterinarian before using in severely debilitated animals. Do not treat within 24 hours of slaughter.

[79 FR 28827, May 20, 2014]

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