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21 C.F.R. § 520.2220a   Sulfadimethoxine oral solution and soluble powder.

Title 21 - Food and Drugs

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

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§ 520.2220a   Sulfadimethoxine oral solution and soluble powder.

(a) Approvals. (1) For oral solution containing 12.5 percent (3.75 grams per ounce) sulfadimethoxine, see Nos. 000010, 000069, 054925, 057561, and 059130 in §510.600(c).

(2) For soluble powder, each 107 grams contain the equivalent of 94.6 grams of sulfadimethoxine (as the sodium salt); see Nos. 000069, 054925, 057561, 059130, and 061623 in §510.600(c) of this chapter.

(b) Special considerations. Federal law prohibits the extralabel use of this product in lactating dairy cattle.

(c) Related tolerances. See §556.640 of this chapter.

(d) Conditions of use. The oral solution is administered as a cattle drench or diluted as directed to prepare drinking water. The powder is used to prepare a drench or drinking water. The concentrations and uses of the various solutions are as follows:

(1) Broiler and replacement chickens only—(i) Amount. 1.875 (0.05 percent) grams per gallon.

(ii) Indications for use. Treatment of disease outbreaks of coccidiosis, fowl cholera, and infectious coryza.

(iii) Limitations. Administer for 6 consecutive days; do not administer to chickens over 16 weeks of age; as sole source of drinking water and sulfonamide medication; as sulfadimethoxine solution or sulfadimethoxine soluble sodium salt; withdraw 5 days before slaughter.

(2) Meat-producing turkeys only—(i) Amount. 0.938 (0.025 percent) grams per gallon.

(ii) Indications for use. Treatment of disease outbreaks of coccidiosis and fowl cholera.

(iii) Limitations. Administer for 6 consecutive days; do not administer to turkeys over 24 weeks of age; as sole source of drinking water and sulfonamide medication; as sulfadimethoxine solution or sulfadimethoxine soluble sodium salt; withdraw 5 days before slaughter.

(3) Dairy calves, dairy heifers, and beef cattle only—(i) Amount. 1.18 to 2.36 (0.031 to 0.062 percent) grams per gallon.

(ii) Indications for use. Treatment of shipping fever complex, bacterial pneumonia, calf diphtheria, and foot rot.

(iii) Administer 2.5 grams per 100 pounds of body weight for first day, then 1.25 grams per 100 pounds of body weight per day for the next 4 consecutive days; in drinking water or drench; available as a sulfadimethoxine soluble powder or a 12.5 percent sulfadimethoxine sodium solution (3.75 grams sulfadimethoxine per fluid ounce); if no improvement within 2 to 3 days, reevaluate diagnosis; do not treat beyond 5 days; withdraw 7 days before slaughter. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.

[40 FR 13838, Mar. 27, 1975, as amended at 58 FR 6092, Jan. 26, 1993; 59 FR 56000, Nov. 10, 1994; 61 FR 4875, Feb. 9, 1996; 62 FR 8371, Feb. 25, 1997; 62 FR 23357, Apr. 30, 1997; 62 FR 35076, June 30, 1997; 62 FR 40932, July 31, 1997; 63 FR 59714, Nov. 5, 1998; 64 FR 18572, Apr. 15, 1999; 70 FR 73137, Dec. 9, 2005; 71 FR 13542, Mar. 16, 2006]

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