21 CFR § 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 § 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 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.