21 CFR § 520.2042 - Pyrantel pamoate tablets.

---
identifier: "/us/cfr/t21/s520.2042"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 520.2042 - Pyrantel pamoate tablets."
title_number: 21
title_name: "Food and Drugs"
section_number: "520.2042"
section_name: "Pyrantel pamoate tablets."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "E"
subchapter_name: "ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS"
part_number: "520"
part_name: "ORAL DOSAGE FORM NEW ANIMAL DRUGS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 360b."
regulatory_source: "40 FR 13838, Mar. 27, 1975, unless otherwise noted."
cfr_part: "520"
---


# 520.2042 Pyrantel pamoate tablets.

(a) *Specifications.* Each tablet contains pyrantel pamoate equivalent to 22.7, 45.4, or 113.5 milligrams of pyrantel base.

(b) *Sponsor.* See No. 017135 in § 510.600(c) of this chapter.

(c) *Conditions of use.* It is used for dogs as follows:

(1) *Amount.* For dogs weighing over 5 pounds, use at least 2.27 milligrams of pyrantel base per pound of body weight; for dogs weighing 5 pounds or less, use at least 4.54 milligrams of pyrantel base per pound of body weight.

(2) *Indications for use.* For removal and control of large roundworms (ascarids) (*Toxocara canis* and *Toxascaris leonina*), and hookworms (*Ancylostoma caninum* and *Uncinaria stenocephala*).

(3) *Limitations.* Administer orally directly or in a small amount of food. To prevent reinfection of *T. canis* in puppies, lactating bitches after whelping, and adult dogs; treat puppies 2, 3, 4, 6, 8, and 10 weeks of age; treat lactating bitches 2 to 3 weeks after whelping; routinely treat adult dogs monthly. Do not withhold food prior to or after treatment. The presence of these parasites should be confirmed by laboratory fecal examination. A followup fecal examination should be conducted 2 to 4 weeks after first treatment regimen to determine the need for re-treatment. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.

[43 FR 52700, Nov. 14, 1978, as amended at 49 FR 22073, May 25, 1984; 57 FR 48163, Oct. 22, 1992; 58 FR 44611, Aug. 24, 1993]