21 C.F.R. § 520.1720e   Phenylbutazone powder.


Title 21 - Food and Drugs


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

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§ 520.1720e   Phenylbutazone powder.

(a) Specifications. Each 10 grams (g) of powder contains 1 g phenylbutazone.

(b) Sponsor. See No. 057699 in §510.600(c) of this chapter.

(c) Conditions of use in horses—(1) Amount. Administer 1 to 2 g (1 to 2 level scoops, using the scoop provided) per 500 pounds of body weight on a small amount of palatable feed.

(2) Indications for use. For the relief of inflammatory conditions associated with the musculoskeletal system.

(3) Limitations. Do not exceed 4 g per animal daily. Administer at a relatively high dosage level for the first 48 hours, then reduce gradually to a maintenance dosage level with the lowest dosage maintained at the level capable of producing the desired clinical response. Do not use in horses intended for human consumption. Federal law prohibits the extralabel use of this product in female cattle 20 months of age or older. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[71 FR 876, Jan. 6, 2006]

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