(a) Specifications. Each milliliter of solution contains 20 milligrams (mg) of tripelennamine hydrochloride.
(b) Sponsors. See Nos. 016592 and 051031 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.741 of this chapter.
(d) Conditions of use - (1) Dogs and cats - (i) Amount. Administer 0.5 mg per pound of body weight by intramuscular injection.
(ii) Indications for use. For use in treating conditions in which antihistaminic therapy may be expected to lead to alleviation of some signs of disease.
(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) Horses - (i) Amount. Administer 0.5 mg per pound of body weight by intramuscular injection.
(ii) Indications for use. For use in treating conditions in which antihistaminic therapy may be expected to lead to alleviation of some signs of disease.
(iii) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(3) Cattle - (i) Amount. Administer 0.5 mg per pound of body weight by intravenous or intramuscular injection.
(ii) Indications for use. For use in treating conditions in which antihistaminic therapy may be expected to lead to alleviation of some signs of disease.
(iii) Limitations. Milk taken during treatment and for 24 hours after the last treatment must not be used for human consumption. Cattle must not be slaughtered for human consumption within 4 days following the last treatment with this drug product. Not for use in beef calves less than 2 months of age, dairy calves, and veal calves. A withdrawal period has not been established for this product in pre-ruminating calves. 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; 78 FR 17597, Mar. 22, 2013; 79 FR 16198, Mar. 25, 2014; 81 FR 22524, Apr. 18, 2016; 82 FR 11508, Feb. 24, 2017; 87 FR 58962, Sept. 29, 2022]
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