subchapter_subject: "ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS"
part_code: "520"
part_subject: "ORAL DOSAGE FORM NEW ANIMAL DRUGS"
subpart_code: "B"
subpart_subject: "Specific Administrative Rulings and Decisions"
section_number: "520.1320"
section_subject: "Mebendazole."
cfr_reference: "21 CFR 520.1320"
title_name: "Title 21"
title_subject: "Food and Drugs"
parts_covered: "Parts 500 to 599"
revised_date: "Revised as of April 1, 2019"
publication_date: "As of April 1, 2019"
contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
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(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.