CFR > 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 (parts 500 to 590) > PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS > 520.2045—Pyrantel tartrate powder; pyrantel tartrate pellets.

520.2045—Pyrantel tartrate powder; pyrantel tartrate pellets.

(a) Specifications. (1) Pyrantel tartrate powder horse wormer contains 11.3 percent and swine wormer 10.6 percent pyrantel tartrate.
(2) Pyrantel tartrate pellets colt and horse wormer contains 1.25 percent pyrantel tartrate.
(b) Sponsor. (1) See No. 000069 in § 510.600(c) of this chapter for conditions of use provided for in paragraphs (d) (1) and (2) of this section.
(2) See No. 051311 in § 510.600(c) of this chapter, for conditions of use provided for in paragraph (d)(3) of this section.
(c) Related tolerances. See § 556.560 of this chapter.
(d) Conditions of use. It is used in: (1) Horses and ponies:
(i) For the removal and control of infections from the following mature parasites: Large strongyles (Strongylus vulgaris, Strongylus edentatus, Strongylus equinus ), small strongyles (Trichonema spp., Triodontophorus ), pinworms (Oxyuris ), and large roundworms (Parascaris ).
(ii) It is administered as a single dose at 0.57 gram of pyrantel tartrate per 100 pounds of body weight mixed with the usual grain ration.
(iii) It is recommended that severely debilitated animals not be treated with this drug. Do not administer by stomach tube or dose syringe. The drug should be used immediately after the package is opened.
(iv) Warning: Not for use in horses and ponies to be slaughtered for food purposes.
(2) Swine:
(i) For the removal and control of large roundworms (Ascaris suum) and nodular worm (Oesophagostomum) infections.
(ii) It is added to feed at 0.4 gram pyrantel tartrate per pound of nonpelleted 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.
(iii) Fast pigs over night for optimum results. Water should be made available to animals during fasting and treatment periods. Consult veterinarian before using in severely debilitated animals. The drug should be used immediately after the package is opened.
(iv) Warning: Do not treat within 24 hours of slaughter.
(3) Horses and colts:
(i) For the removal and control of infections from the following mature parasites: Large strongyles (Strongylus vulgaris, Strongylus edentatus, Strongylus equinus ), small strongyles (Trichonema spp., Triodontophorus ), pinworms (Oxyuris ), and large roundworms (Parascaris ).
(ii) It is administered as a single dose at 12.5 milligrams of pyrantel tartrate per 2.2 pounds of body weight mixed with the usual grain ration.
(iii) It is recommended that severely debilitated animals not be treated with this drug.
(iv) Warning: Do not use in horses or colts intended for food.

Code of Federal Regulations

[40 FR 13838, Mar. 27, 1975, as amended at 59 FR 28769, June 3, 1994; 69 FR 41427, July 9, 2004]