21 C.F.R. § 520.2345b   Tetracycline tablets.


Title 21 - Food and Drugs


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

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§ 520.2345b   Tetracycline tablets.

(a) Specifications. Each tablet contains 100, 250, or 500 milligrams of tetracycline (as the hydrochloride).

(b) Sponsor. For 100, 250, or 500 milligrams per tablet, see No. 000069 in §510.600(c) of this chapter. For 250 milligrams per tablet, see No. 000009 in §510.600(c) of this chapter.

(c) Conditions of use. Dogs—(1) Amount. 25 milligrams per pound of body weight per day in divided doses every 6 hours.

(2) Indications for use. Treatment of infections caused by organisms sensitive to tetracycline hydrochloride, such as bacterial gastroenteritis due to E. coli and urinary tract infections due to Staphylococcus spp. and E. coli.

(3) Limitations. Administer orally; continue treatment until symptoms of the disease have subsided and temperature is normal for 48 hours; not for use in animals raised for food production; Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[57 FR 37327, Aug. 18, 1992]

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