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Code of Federal Regulations (Last Updated: April 5, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter E - Animal Drugs, Feeds, and Related Products |
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Part 516 - New Animal Drugs for Minor Use and Minor Species |
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Subpart E - Conditionally Approved New Animal Drugs For Minor Use and Minor Species |
§ 516.1858 - Potassium bromide.
Latest version.
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§ 516.1858 Potassium bromide.
(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 once daily. The dosage can be divided and should be adjusted to clinical response.
(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. It is a violation of Federal law to use this product other than as directed in the labeling.
[86 FR 57996, Oct. 20, 2021]