21 C.F.R. § 522.2615   Tripelennamine hydrochloride injection.


Title 21 - Food and Drugs


Title 21: Food and Drugs
PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

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§ 522.2615   Tripelennamine hydrochloride injection.

(a) Specifications. Each milliliter of aqueous solution contains 20 milligrams of tripelennamine hydrochloride.

(b) Sponsor. See Nos. 053501 and 059130 in §510.600(c) of this chapter.

(c) Related tolerances. See §556.741 of this chapter.

(d) Conditions of use—(1) Amount—(i) Dogs, cats, and horses. For intramuscular use only at a dose of 0.5 milligram per pound of body weight.

(ii) Cattle. Administer intravenously or intramuscularly at a dose of 0.5 milligram per pound of body weight.

(2) Indications for use. For use in treating conditions in which antihistaminic therapy may be expected to lead to alleviation of some signs of disease.

(3) Limitations. Do not use in horses intended for food purposes. Treated cattle must not be slaughtered for food during treatment and for 4 days following the last treatment. Milk that has been taken during treatment and for 24 hours (two milkings) after the last treatment must not be used for food. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[51 FR 44450, Dec. 10, 1986, as amended at 61 FR 29480, June 11, 1996; 62 FR 4164, Jan. 29, 1997]

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