GroundRules
21 CFR 520.1858: Potassium bromide chewable tablets.
Where this section sits in the code
- 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
- PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS
(a) Specifications. Each chewable tablet contains 250 or 500 milligrams (mg) potassium bromide.
(b) Sponsor. See No. 055246 in § 510.600(c) of this chapter.
(c) Conditions of use—(1) Amount. Administer 25 to 68 mg per kilogram (11 to 31 mg per pound) of body weight. The dosage should be adjusted based on monitoring of clinical response of the individual patient.
(2) Indications for use. For the control of seizures associated with idiopathic epilepsy in dogs.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Collected 2026-08-27T02:24:47Z. Source file · JSON