(a) Specifications. Each tablet contains 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, or 1.0 milligrams (mg) levothyroxine sodium.

(b) Sponsor. See No. 061690 in §510.600(c) of this chapter.

(c) Conditions of use—(1) Amount. Administer by mouth 0.1 mg/10 pounds of body weight (0.022 mg/kilogram) as a single dose every 24 hours or as a divided dose every 12 hours.

(2) Indications for use. For replacement therapy for diminished thyroid function in dogs.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[81 FR 22523, Apr. 18, 2016]