---
kind: "section"
citation: "21 C.F.R. § 516.1760"
title: "21"
number: "516.1760"
heading: "Phenobarbital."
url: "https://uscodex.org/cfr/21/516.1760"
---

# §516.1760. Phenobarbital.

- (a) **Specifications.** Each tablet contains 15, 16.2, 30, 32.4, 60, 64.8, 97.2 or 100 milligrams (mg) phenobarbital.
- (b) **Sponsor.** See No. 064950 in [§ 510.600(c)](/cfr/21/510.600.md?p=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.

## Notes

### Amendments

[88 FR 84699, Dec. 6, 2023; 89 FR 85426, Oct. 28, 2024]

### Source

Source: 72 FR 57200, Oct. 9, 2007, unless otherwise noted.

### Authority

Authority: 21 U.S.C. 360ccc-1, 360ccc-2, 371.

### Source

Source: 72 FR 41017, July 26, 2007, unless otherwise noted.

### Amendments

[88 FR 84699, Dec. 6, 2023; 89 FR 85426, Oct. 28, 2024]