---
kind: "section"
citation: "21 C.F.R. § 520.2043"
title: "21"
number: "520.2043"
heading: "Pyrantel pamoate suspension."
url: "https://uscodex.org/cfr/21/520.2043"
---

# §520.2043. Pyrantel pamoate suspension.

- (a) **Specifications.**
  - (1) **Each milliliter (mL) contains pyrantel pamoate equivalent to 50 milligrams (mg) pyrantel base.**
  - (2) Each mL contains pyrantel pamoate equivalent to 2.27 or 4.54 mg pyrantel base.
  - (3) Each mL contains pyrantel pamoate equivalent to 4.54 mg pyrantel base.
- (b) **Sponsors.** See sponsors in [§ 510.600(c)](/cfr/21/510.600.md?p=c) of this chapter for uses as in [paragraph (d)](#d) of this section.
  - (1) **Nos.** 054771, 058829, and 069043 for use of the product described in [paragraph (a)(1)](#a-1) as in [paragraph (d)(1)](#d-1) of this section.
  - (2) **Nos.** 054771, 058198, and 058829 for use of the products described in [paragraph (a)(2)](#a-2) of this section as in [paragraph (d)(2)](#d-2) of this section.
  - (3) **No.** 023851 for use of the product described in [paragraph (a)(3)](#a-3) as in [paragraph (d)(2)](#d-2) of this section.
- (c) **Special considerations.** See [§ 500.25](/cfr/21/500.25.md) of this chapter.
- (d) **Conditions of use—**
  - (1) **Horses and ponies.** It is used as follows:
    - (i) **Amount.** 3 mg per pound (/lb) body weight as a single dose mixed with the usual grain ration, or by stomach tube or dose syringe.
    - (ii) **Indications for use.** For the removal and control of mature infections of large strongyles (Strongylus vulgaris, S. edentatus, S. equinus); pinworms (Oxyuris equi); large roundworms (Parascaris equorum); and small strongyles.
    - (iii) **Limitations.** Do not use in horses intended for human consumption. When the drug is for administration by stomach tube, it shall be labeled: “Federal law restricts this drug to use by or on the order of a licensed veterinarian.”
  - (2) **Dogs.** It is used as follows:
    - (i) **Dogs and puppies—**
      - (A) **Amount.** 2.27 mg/lb body weight as a single dose in the animal's feed bowl by itself or mixed in a small quantity of food.
      - (B) **Indications for use.** For the removal of large roundworms (Toxocara canis and Toxascaris leonina) and hookworms (Ancylostoma caninum and Uncinaria stenocephala).
      - (C) **Limitations.** Additional treatment may be required and should be confirmed by fecal examination within 2 to 4 weeks.
    - (ii) **Dogs, puppies, and lactating bitches after whelping—**
      - (A) **Amount.** 2.27 mg/lb body weight.
      - (B) **Indications for use.** To prevent reinfections of T. canis.
      - (C) **Limitations.** Administer to puppies at 2, 3, 4, 6, 8, and 10 weeks of age. Administer to lactating bitches 2 to 3 weeks after whelping. Adult dogs kept in heavily contaminated quarters may be treated at monthly intervals.

## Notes

### Amendments

[67 FR 43248, June 27, 2002, as amended at 68 FR 54803, Sept. 19, 2003; 68 FR 55199, Sept. 23, 2003; 68 FR 55825, Sept. 29, 2003; 75 FR 52622, Aug. 27, 2010; 76 FR 17337, Mar. 29, 2011; 78 FR 17596, Mar. 22, 2013; 79 FR 28827, May 20, 2014; 80 FR 76386, Dec. 9, 2015; 81 FR 17607, Mar. 30, 2016; 86 FR 14819, Mar. 19, 2021]

### Authority

Authority: 21 U.S.C. 360b.

### Source

Source: 40 FR 13838, Mar. 27, 1975, unless otherwise noted.

### Amendments

[67 FR 43248, June 27, 2002, as amended at 68 FR 54803, Sept. 19, 2003; 68 FR 55199, Sept. 23, 2003; 68 FR 55825, Sept. 29, 2003; 75 FR 52622, Aug. 27, 2010; 76 FR 17337, Mar. 29, 2011; 78 FR 17596, Mar. 22, 2013; 79 FR 28827, May 20, 2014; 80 FR 76386, Dec. 9, 2015; 81 FR 17607, Mar. 30, 2016; 86 FR 14819, Mar. 19, 2021]