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21 CFR 520.1858

§ 520.1858 Potassium bromide chewable tablets.

United States · 21 CFR — Food and Drugs · Status: effective

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21 CFR 520.1858, § 520.1858 Potassium bromide chewable tablets, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/87283
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(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.

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.