StacksVerified U.S. regulatory reference

21 CFR §516.1858

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
  1. (a)Specifications. Each chewable tablet contains 250 or 500 milligrams (mg) potassium bromide.
  2. (b)Sponsor. See No. 055246 in § 510.600(c) of this chapter.
  3. (c)Conditions of use—(1) Amount. Administer 25 to 68 mg per kilogram (11 to 31 mg per pound) of body weight once daily. The dosage can be divided and should be adjusted to clinical response.
    1. (2)Indications for use. For the control of seizures associated with idiopathic epilepsy in dogs.
    2. (3)Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. It is a violation of Federal law to use this product other than as directed in the labeling.