[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR520.222]

[Page 108-109]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS--Table of Contents
 
Sec.  520.222  Bunamidine hydrochloride.

    (a) Chemical name. N,N-Dibutyl-4-(hexyloxy)-1-naphthamidine 
hydrochloride.
    (b) Specifications. The drug is an oral tablet containing 100, 200, 
or 400 milligrams of bunamidine hydrochloride.
    (c) Sponsor. See No. 000061 in Sec.  510.600(c) of this chapter.
    (d) Conditions of use. (1) The drug is intended for oral 
administration to dogs for the treatment of the tapeworms Dipylidium 
caninum, Taenia pisiformis, and Echinococcus granulosus, and to cats for 
the treatment of the tapeworms Dipylidium caninum and Taenia 
taeniaeformis.
    (2) It is administered to cats and dogs at the rate of 25 to 50 
milligrams per

[[Page 109]]

kilogram of body weight. The drug should be given on an empty stomach 
and food should not be given for 3 hours following treatment.
    (3) Tablets should not be crushed, mixed with food, or dissolved in 
liquid. Repeat treatments should not be given within 14 days. The drug 
should not be given to male dogs within 28 days prior to their use for 
breeding. Do not administer to dogs or cats having known heart 
conditions.
    (4) For use only by or on the order of a licensed veterinarian.

[40 FR 13838, Mar. 27, 1975, as amended at 42 FR 13018, Mar. 8, 1977; 46 
FR 48642, Oct. 2, 1981; 61 FR 8873, Mar. 6, 1996; 62 FR 61624, Nov. 19, 
1997]