21 CFR 522.2063 - Pyrilamine.

§ 522.2063 Pyrilamine.

(a)Specifications. Each milliliter of solution contains 20 milligrams (mg) of pyrilamine maleate.

(b)Sponsors. See sponsor numbers in § 510.600(c) of this chapter for uses in paragraph (c) of this section.

(1) No. 000061 for use as in paragraph (c)(1)(i), (2), and (3) of this section.

(2) No. 061623 for use as in paragraph (c)(1)(ii), (2), and (3) of this section.

(c)Conditions of use -

(1)Amount - (i) Horses, 40 to 60 mg per 100 pounds (lbs) body weight; foals, 20 mg/100 lbs body weight. Administer by intramuscular, subcutaneous, or intravenous injection. Dosage may be repeated every 6 to 12 hours whenever necessary.

(ii) Horses, 40 to 60 mg/100 lbs body weight; foals, 20 mg/100 lbs body weight. Administer by slow intravenous injection. Dosage may be repeated every 6 to 12 hours if necessary.

(2)Indications for use. It is intended for treating horses in 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 human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[ 79 FR 16195, Mar. 25, 2014]

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United States Code
U.S. Code: Title 21 - FOOD AND DRUGS