21 CFR §520.2046

1. (a)Specifications.
   1. (1)Each gram of pellets contains 12.5 milligrams (mg) (1.25 percent) pyrantel tartrate; or
   2. (2)Each gram of pellets contains 21.1 mg (2.11 percent) pyrantel tartrate.
2. (b)Sponsors. See sponsor numbers in § 510.600(c) of this chapter:
   1. (1)No. 054771 for use of products described in paragraph (a) as in paragraph (c) of this section.
   2. (2)No. 061133 for use of product described in paragraph (a)(1) as in paragraph (c) of this section.
3. (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.
   1. (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).
   2. (3)Limitations. Do not treat severely debilitated animals with this drug. Do not use in horses intended for human consumption.