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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 Oct 01, 2021.

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

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[Code of Federal Regulations]
[Title 21, Volume 6]
[CITE: 21CFR520.1320]



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. 520.1320 Mebendazole.

(a) Specifications. (1) Each gram of powder contains either 40 or 166.7 milligrams of mebendazole.

(2) Each gram of paste contains 200 milligrams of mebendazole.

(3) Each milliliter of suspension contains 33.3 milligrams of mebendazole.

(b) Sponsor. See No. 000061 in § 510.600(c) of this chapter.

(c) Conditions of use - (1) Horses - (i) Amount. 1 gram of mebendazole per 250 pounds of body weight per dose, as an oral powder, paste or suspension.

(ii) Indications for use. For treatment of infections caused by large roundworms (Parascaris equorum ); large strongyles (Strongylus edentatus, S. equinus, S. vulgaris ); small strongyles; and mature and immature (4th larval stage) pinworms (Oxyuris equi ).

(iii) Limitations. The drug is compatible with carbon disulfide. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) Dogs - (i) Amount. Administer 100 milligrams of mebendazole per 10 pounds of body weight, once daily for 3 days, as an oral powder by mixing with a small quantity of food, preferably before the regular meal.

(ii) Indications for use. The drug is used for treatment of infections of roundworms (Toxocara canis ), hookworms (Ancylostoma caninum, Uncinaria stenocephala ), whipworms (Trichuris vulpis ), and tapeworms (Taenia pisiformis ).

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

[78 FR 28823, May 20, 2014]

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