21 C.F.R. § 520.1330   Meclofenamic acid granules.


Title 21 - Food and Drugs


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

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§ 520.1330   Meclofenamic acid granules.

(a) Chemical name. N-(2,6-Dichlorom-tolyl) anthranilic acid.

(b) Specifications. The drug is in granular form containing 5 percent meclofenamic acid.

(c) Sponsor. See No. 000856 in §510.600(c) of this chapter.

(d) Conditions of use. (1) The drug is used in horses for the treatment of acute or chronic inflammatory diseases involving the musculoskeletal system.

(2) It is administered orally at a dosage of 1 milligram per pound of body weight (1 gram per 1,000 pounds) once daily for 5 to 7 days by addition to the daily grain ration.

(3) Treatment beyond the initial 5- to 7-day period may be indicated. A maintenance dosage level should be individualized for each animal.

(4) This drug should not be administered to horses with active gastrointestinal, hepatic, or renal disease.

(5) Not for use in horses intended for food.

(6) Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[41 FR 5632, Feb. 9, 1976, as amended at 53 FR 23390, June 22, 1988]

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