---
kind: "section"
citation: "21 C.F.R. § 520.1870"
title: "21"
number: "520.1870"
heading: "Praziquantel tablets."
url: "https://uscodex.org/cfr/21/520.1870"
---

# §520.1870. Praziquantel tablets.

- (a) **Specifications.**
  - (1) **Each tablet contains 34 milligrams (mg) praziquantel.**
  - (2) Each tablet contains 11.5 or 23 mg praziquantel.
  - (3) **Each chewable tablet contains 23 mg praziquantel.**
- (b) **Sponsors.** See sponsors in [§ 510.600(c)](/cfr/21/510.600.md?p=c) of this chapter.
  - (1) **No.** 058198 for use of product described in [paragraph (a)(1)](#a-1) of this section as in [paragraph (c)(1)](#c-1) of this section and for use of product described in [paragraph (a)(2)](#a-2) of this section as in [paragraph (c)(2)](#c-2) of this section.
  - (2) **Nos.** 069043 and 086101 for use of product described in [paragraph (a)(1)](#a-1) of this section as in [paragraphs (c)(1)](#c-1) of this section.
  - (3) **No.** 086101 for use of product as described in [paragraph (a)(3)](#a-3) of this section as in [paragraph (c)(2)](#c-2) of this section.
- (c) **Conditions of use—**
  - (1) **Dogs—**
    - (i) **Amount.** 5 pounds (lb) and under, 1/2 tablet (17 mg); 6 to 10 lb, 1 tablet (34 mg); 11 to 15 lb, 1 1/2 tablets (51 mg); 16 to 30 lb, 2 tablets (68 mg); 31 to 45 lb, 3 tablets (102 mg); 46 to 60 lb, 4 tablets (136 mg); over 60 lb, 5 tablets maximum (170 mg). Administer directly by mouth or crumbled and in feed.
    - (ii) **Indications for use—**
      - (A) For removal of canine cestodes Dipylidium caninum and Taenia pisiformis.
      - (B) For removal of the canine cestode Echinococcus granulosus, and for removal and control of the canine cestode Echinococcus multilocularis.
    - (iii) **Limitations—**
      - (A) If labeled only for use as in [paragraph (c)(1)(ii)(A)](#c-1-ii-A) of this section: Not intended for use in puppies less than 4 weeks of age. Consult your veterinarian before administering tablets to weak or debilitated animals and for assistance in the diagnosis, treatment, and control of parasitism.
      - (B) If labeled for use as in [paragraph (c)(1)(ii)(B)](#c-1-ii-B) of this section: Federal law restricts this drug to use by or on the order of a licensed veterinarian.
  - (2) **Cats—**
    - (i) **Indications for use.** For removal of feline cestodes Dipylidium caninum and Taenia taeniaeformis.
    - (ii) **Dosage.** Cats 4 pounds and under, 11.5 mg; 5 to 11 pounds, 23 mg; over 11 pounds, 34.5 mg.
    - (iii) **Limitations.** Administer directly by mouth or crumbled and in feed. Not intended for use in kittens less than 6 weeks of age. For over the counter use: Consult your veterinarian before administering tablets to weak or debilitated animals, and for assistance in the diagnosis, treatment, and control of parasitism.

## Notes

### Amendments

[46 FR 60570, Dec. 11, 1981, as amended at 47 FR 26377, June 18, 1982; 55 FR 2234, Jan. 23, 1990; 58 FR 7864, Feb. 10, 1993; 58 FR 42853, Aug. 12, 1993; 68 FR 57351, Oct. 3, 2003; 69 FR 62181, Oct. 25, 2004; 78 FR 17596, Mar. 22, 2013; 81 FR 17607, Mar. 30, 2016; 86 FR 14819, Mar. 19, 2021; 87 FR 58961, Sept. 29, 2022; 88 FR 27699, May 3, 2023; 91 FR 20342, Apr. 16, 2026]

### Authority

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

### Source

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

### Amendments

[46 FR 60570, Dec. 11, 1981, as amended at 47 FR 26377, June 18, 1982; 55 FR 2234, Jan. 23, 1990; 58 FR 7864, Feb. 10, 1993; 58 FR 42853, Aug. 12, 1993; 68 FR 57351, Oct. 3, 2003; 69 FR 62181, Oct. 25, 2004; 78 FR 17596, Mar. 22, 2013; 81 FR 17607, Mar. 30, 2016; 86 FR 14819, Mar. 19, 2021; 87 FR 58961, Sept. 29, 2022; 88 FR 27699, May 3, 2023; 91 FR 20342, Apr. 16, 2026]