21 C.F.R. § 516.1760

Current through May 31, 2024
Section 516.1760 - Phenobarbital
(a)Specifications. Each tablet contains 16.2, 32.4, 64.8, or 97.2 milligrams (mg) phenobarbital.
(b)Sponsor. See No. 064950 in § 510.600(c) of this chapter.
(c)Conditions of use -
(1)Amount. Administer phenobarbital as tablets given orally twice a day at the minimum dosage of 2.5 mg per kilogram of body weight (mg/kg) and may be titrated to effect to a maximum dosage of 5 mg/kg. The dosage of phenobarbital tablets should be adjusted based on monitoring the 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. It is a violation of Federal law to use this product other than as directed in the labeling.

21 C.F.R. §516.1760

88 FR 84699, Dec. 6, 2023
88 FR 84699, 12/6/2023