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21 C.F.R. § 520.816   Epsiprantel tablets.

Title 21 - Food and Drugs

Title 21: Food and Drugs
PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS

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§ 520.816   Epsiprantel tablets.

(a) Specifications. Each tablet contains either 12.5, 25, 50, or 100 milligrams of epsiprantel.

(b) Sponsor. See No. 000069 in §510.600(c) of this chapter.

(c) Conditions of use—(1) Dogs—(i) Amount. 2.5 milligrams per pound of body weight.

(ii) Indications for use. Removal of canine cestodes Dipylidium caninum and Taenia pisiformis.

(2) Cats—(i) Amount. 1.25 milligrams per pound of body weight.

(ii) Indications for use. Removal of feline cestodes D. caninum and T. taeniaeformis.

(3) Limitations. For oral use only as a single dose. Do not use in animals less than 7 weeks of age. Safety of use in pregnant or breeding animals has not been established. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[54 FR 50615, Dec. 8, 1989, as amended at 56 FR 50653, Oct. 8, 1991; 60 FR 55659, Nov. 2, 1995]

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