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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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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 6]
[CITE: 21CFR520.903c]



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. 520.903c Febantel and praziquantel paste.

(a) Specifications. Each gram of paste contains 34 milligrams of febantel and 3.4 milligrams of praziquantel.

(b) Sponsor. See No. 058198 in § 510.600(c) of this chapter.

(c) Conditions of use - (1) Amount - (i) Dogs and cats (over 6 months of age): 10 milligrams of febantel and 1 milligram of praziquantel per kilogram of body weight (1 gram of paste per 7.5 pounds body weight) administered by mouth or in the food once daily for 3 days.

(ii) Puppies and kittens (less than 6 months of age): 15 milligrams of febantel and 1.5 milligrams of praziquantel per kilogram of body weight (1 gram of paste per 5 pounds body weight) administered by mouth on a full stomach once daily for 3 days.

(2) Indications for use. (i) Dogs and puppies: For removal of hookworms (Ancylostoma caninum and Uncinaria stenocephala ), whipworms (Trichuris vulpis ), ascarids (Toxocara canis and Toxascaris leonina ), and tapeworms (Dipylidium caninum and Taenia pisiformis ).

(ii) Cats and kittens: For removal of hookworms (Ancylostoma tubaeforme ), ascarids (Toxocara cati ) and tapeworms (Dipylidium caninum and Taenia taeniaeformis ).

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

[50 FR 19167, May 7, 1985, as amended at 53 FR 48533, Dec. 1, 1988; 56 FR 50813, Oct. 9, 1991; 79 FR 28821, May 20, 2014. Redesignated at 85 FR 18119, Apr. 1, 2020; 86 FR 14818, Mar. 19, 2021]

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