CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER E—ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS (parts 500 to 590) > PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS > 520.2170—Sulfabromomethazine sodium boluses.

520.2170—Sulfabromomethazine sodium boluses.

(a) Specifications. Each bolus contains 15 grams of sulfabromomethazine sodium.
(b) Related tolerance. See § 556.620 of this chapter.
(c) Sponsor. See No. 050604 in § 510.600(c) of this chapter.
(d) NAS/NRC status. These conditions of use are NAS/NRC reviewed and found effective. NADA's for these uses need not include effectiveness data as specified by § 514.111 of this chapter, but may require bioequivalency and safety information.
(e) Conditions of use. Cattle— (1) Amount. 90 milligrams per pound body weight.
(2) Indications for use. Treatment of necrotic pododermatitis (foot rot) and calf diphtheria caused by Fusobacterium necrophorum; colibacillosis (scours) caused by Escherichia coli; bacterial pneumonia and bovine respiratory disease complex (shipping fever complex) associated with Pasteurella spp.; acute metritis and acute mastitis caused by Streptococcus spp.
(3) Limitations. Administer orally; repeat in 48 hours if necessary; milk taken from animals within 96 hours (8 milkings) of latest treatment must not be used for food; do not administer within 18 days of slaughter; discontinue use if hematuria, crystalluria or severe depression are noticed; if signs persist after 2 or 3 days consult a veterinarian.

Code of Federal Regulations

[47 FR 30243, July 13, 1982, as amended at 62 FR 63270, Nov. 28, 1997]