21 CFR §520.2044

1. (a)Specifications—(1) Each milliliter (mL) contains 180 milligrams (mg) pyrantel base (as pyrantel pamoate).
   1. (2)Each mL contains 226 mg pyrantel base (as pyrantel pamoate).
   2. (3)Each mL contains 171 mg pyrantel base (as pyrantel pamoate).
2. (b)Sponsors. See sponsors in § 510.600(c) of this chapter.
   1. (1)No. 054771 for use of product described in paragraph (a)(1) of this section as in paragraph (d)(1)(i) and (d)(2) of this section.
   2. (2)No. 017135 for use of product described in paragraph (a)(2) of this section as in paragraph (d) of this section.
   3. (3)No. 061133 for use of product described in paragraph (a)(3) of this section as in paragraph (d)(1)(i) and (d)(2) of this section.
3. (c)Special considerations. See § 500.25 of this chapter.
4. (d)Conditions of use. It is used in horses and ponies as follows:
   1. (1)Amounts and indications for use.
      1. (i)3 mg per pound (/lb) body weight as single oral dose for removal and control of infections from the following mature parasites: large strongyles (Strongylus vulgaris, S. edentatus, S. equinus); small strongyles; pinworms (Oxyuris equi); and large roundworms (Parascaris equorum).
      2. (ii)6 mg/lb body weight as single oral dose for the removal and control of mature infections of tapeworms (Anoplocephala perfoliata).
   2. (2)Limitations. Do not use in horses intended for human consumption.