(a) Specifications. (1) Each ounce of solution contains 3.75 grams (12.5 percent) sulfadimethoxine.
(1) Each ounce of solution contains 3.75 grams (12.5 percent) sulfadimethoxine.
(2) Each 107 grams of powder contains the equivalent of 94.6 grams sulfadimethoxine as sulfadimethoxine sodium.
(b) Sponsors. See sponsor numbers in Sec. 510.600(c) of this chapter:
(1) Nos. 000859, 054628, 054771, 054925, and 057561 for use of the product described in paragraph (a)(1) of this section.
(2) Nos. 054771, 054925, 057561, 058829, 061623, and 066104 for use of the product described in paragraph (a)(2) of this section.
(c) Related tolerances. See Sec. 556.640 of this chapter.
(d) Conditions of use--(1) Broiler and replacement chickens--(i) Amount. Administer 1.875 grams per gallon (0.05 percent) of drinking water for 6 consecutive days.
(1) Broiler and replacement chickens--(i) Amount. Administer 1.875 grams per gallon (0.05 percent) of drinking water for 6 consecutive days.
(i) Amount. Administer 1.875 grams per gallon (0.05 percent) of drinking water for 6 consecutive days.
(ii) Indications for use. For treatment of outbreaks of coccidiosis, fowl cholera, and infectious coryza.
(iii) Limitations. Do not administer to chickens over 16 weeks of age. As sole source of drinking water and sulfonamide medication. Withdraw 5 days before slaughter.
(2) Turkeys--(i) Amount. Administer 0.938 grams per gallon (0.025 percent) of drinking water for 6 consecutive days.
(i) Amount. Administer 0.938 grams per gallon (0.025 percent) of drinking water for 6 consecutive days.
(ii) Indications for use. Growing turkeys: For treatment of disease outbreaks of coccidiosis and fowl cholera.
(iii) Limitations. Do not administer to turkeys over 24 weeks of age. Use as the sole source of drinking water and sulfonamide medication. Withdraw 5 days before slaughter.
(3) Cattle--(i) Amount. 1.18 to 2.36 grams per gallon (0.031 to 0.062 percent) of drinking water. As a drench, 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. If no improvement within 2 to 3 days, reevaluate diagnosis. Do not treat beyond 5 days.
(i) Amount. 1.18 to 2.36 grams per gallon (0.031 to 0.062 percent) of drinking water. As a drench, 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. If no improvement within 2 to 3 days, reevaluate diagnosis. Do not treat beyond 5 days.
(ii) Indications for use. Dairy calves, dairy heifers, and beef cattle: For the treatment of shipping fever complex and bacterial pneumonia associated with Pasteurella spp. sensitive to sulfadimethoxine; and calf diphtheria and foot rot associated with Fusobacterium necrophorum (Sphaerophorus necrophorus) sensitive to sulfadimethoxine.
(iii) Limitations. 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. Federal law prohibits the extralabel use of this product in lactating dairy cattle. [79 FR 28829, May 20, 2014] Sec. 520.2220b Sulfadimethoxine suspension.
(a) Specifications. Each milliliter of suspension contains 50 milligrams (mg) sulfadimethoxine.
(b) Sponsors. See Nos. 000061 and 054771 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in dogs and cats--(1) Amount. Administer orally 25 mg per pound of body weight, followed by 12.5 mg per pound of body weight daily.
(1) Amount. Administer orally 25 mg per pound of body weight, followed by 12.5 mg per pound of body weight daily.
(2) Indications for use. For the treatment of sulfonamide susceptible bacterial infections in dogs and cats and enteritis associated with coccidiosis in dogs.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [79 FR 28829, May 20, 2014] Sec. 520.2220c Sulfadimethoxine tablet.
(a) Specifications. Each tablet contains 125, 250, or 500 milligrams (mg) sulfadimethoxine.
(b) Sponsors. See Nos. 000061 and 054771 in Sec. 510.600(c) of this chapter.
(c) [Reserved]
(d) Conditions of use in dogs and cats--(1) Amount. Administer 25 milligrams (mg) per pound of body weight on the first day followed by 12.5 milligrams (mg) per pound of body weight per day until the animal is free of symptoms for 48 hours.
(1) Amount. Administer 25 milligrams (mg) per pound of body weight on the first day followed by 12.5 milligrams (mg) per pound of body weight per day until the animal is free of symptoms for 48 hours.
(2) Indications for use. Treatment of sulfadimethoxine-susceptible bacterial infections.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [79 FR 28829, May 20, 2014] Sec. 520.2220d Sulfadimethoxine bolus.
(a) Specifications. Each bolus contains 2.5, 5, or 15 grams sulfadimethoxine.
(b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
(c) Related tolerances. See Sec. 556.640 of this chapter.
(d) Conditions of use in cattle--(1) Amount. Administer 2.5 grams per 100 pounds body weight for 1 day followed by 1.25 grams per 100 pounds body weight per day; treat for 4 to 5 days.
(1) Amount. Administer 2.5 grams per 100 pounds body weight for 1 day followed by 1.25 grams per 100 pounds body weight per day; treat for 4 to 5 days.
(2) Indications for use. For the treatment of shipping fever complex and bacterial pneumonia associated with Pasteurella spp. sensitive to sulfadimethoxine; and calf diphtheria and foot rot associated with Fusobacterium necrophorum sensitive to sulfadimethoxine.
(3) Limitations. Do not administer within 7 days of slaughter; milk that has been taken from animals during treatment and 60 hours (5 milkings) after the latest treatment must not be used for food. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. [79 FR 28829, May 20, 2014] Sec. 520.2220e Sulfadimethoxine extended-release bolus.
(a) Specifications. Each extended-release bolus contains 12.5 grams sulfadimethoxine.
(b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
(c) Related tolerances. See Sec. 556.640 of this chapter.
(d) Conditions of use in beef cattle and non-lactating dairy cattle--(1) Amount. Administer one 12.5-gram-sustained-release bolus for the nearest 200 pounds of body weight, i.e., 62.5 milligrams per pound of body weight. Do not repeat treatment for 7 days.
(1) Amount. Administer one 12.5-gram-sustained-release bolus for the nearest 200 pounds of body weight, i.e., 62.5 milligrams per pound of body weight. Do not repeat treatment for 7 days.
(2) Indications for use. For the treatment of shipping fever complex and bacterial pneumonia associated with Pasteurella spp. sensitive to sulfadimethoxine; and calf diphtheria and foot rot associated with Fusobacterium necrophorum sensitive to sulfadimethoxine.
(3) Limitations. Do not use in female dairy cattle 20 months of age or older. Do not administer within 12 days of slaughter. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [79 FR 28830, May 20, 2014] Sec. 520.2220f Sulfadimethoxine and ormetoprim tablet.
(a) Specifications. Each tablet contains 120 milligrams (mg) (100 mg sulfadimethoxine and 20 mg ormetoprim), 240 mg (200 mg sulfadimethoxine and 40 mg ormetoprim), 600 mg (500 mg sulfadimethoxine and 100 mg ormetoprim), or 1200 mg (1000 mg sulfadimethoxine and 200 mg ormetoprim).
(b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in dogs--(1) Amount. On the first day of treatment, administer 25 mg per pound (55 mg per kilogram) of body weight. Then follow with a daily dosage of 12.5 mg per pound (27.5 mg per kilogram) of body weight. Do not exceed a total of 21 consecutive days.
(1) Amount. On the first day of treatment, administer 25 mg per pound (55 mg per kilogram) of body weight. Then follow with a daily dosage of 12.5 mg per pound (27.5 mg per kilogram) of body weight. Do not exceed a total of 21 consecutive days.
(2) Indications of use. Treatment of skin and soft tissue infections (wounds and abscesses) in dogs caused by strains of Staphylococcus aureus and Escherichia coli and urinary tract infections caused by E. coli, Staphylococcus spp., and Proteus mirabilus susceptible to ormetoprim-potentiated sulfadimethoxine.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [79 FR 28830, May 20, 2014]