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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of April 1 2020.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of April 1, 2020]
[CITE: 21CFR520.1199]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER E - ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS

PART 520 -- ORAL DOSAGE FORM NEW ANIMAL DRUGS

Sec. 520.1199 Ivermectin, pyrantel, and praziquantel tablets.

(a) Specifications. Each chewable tablet or soft chewable tablet contains:

(1) 34 micrograms (mcg) ivermectin, 28.5 milligrams (mg) pyrantel pamoate, and 28.5 mg praziquantel;

(2) 68 mcg ivermectin, 57 mg pyrantel pamoate, and 57 mg praziquantel;

(3) 136 mcg ivermectin, 114 mg pyrantel pamoate, and 114 mg praziquantel; or

(4) 272 mcg ivermectin, 228 mg pyrantel pamoate, and 228 mg praziquantel.

(b) Sponsor. See No. 051311 in § 510.600(c) of this chapter.

(c) Conditions of use in dogs - (1) Amount. Administer monthly according to body weight as follows:

(i) 6 to 12 lb: one tablet as described in paragraph (a)(1) of this section.

(ii) 12.1 to 25 lb: one tablet as described in paragraph (a)(2) of this section.

(iii) 25.1 to 50 lb: one tablet as described in paragraph (a)(3) of this section.

(iv) 50.1 to 100 lb: one tablet as described in paragraph (a)(4) of this section.

(v) Greater than 100 lb: use the appropriate combination of tablets.

(2) Indications for use. To prevent canine heartworm disease by eliminating the tissue stage of heartworm larvae (Dirofilaria immitis ) for 1 month (30 days) after infection and for the treatment and control of roundworm (Toxocara canis, Toxascaris leonina ), hookworm (Ancylostoma caninum, Uncinaria stenocephala, Ancylostoma braziliense ) and tapeworm (Dipylidium caninum, Taenia pisiformis ) infections.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[71 FR 65052, Nov. 7, 2006, as amended at 78 FR 28822, May 20, 2014; 83 FR 14587, Apr. 5, 2018]

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