21 C.F.R. § 520.246 Butorphanol tartrate tablets.
Title 21 - Food and Drugs
(a) Specifications. Each tablet contains 1, 5, or 10 milligrams of butorphanol base activity as butorphanol tartrate. (b) Sponsor. See No. 000856 in §510.600(c) of this chapter. (c) Conditions of use. The drug is used for the treatment of dogs as follows: (1) Amount. 0.25 milligram of butorphanol base activity per pound of body weight. (2) Indications for use. For the relief of chronic nonproductive cough associated with tracheo-bronchitis, tracheitis, tonsillitis, laryngitis, and pharyngitis associated with inflammatory conditions of the upper respiratory tract. (3) Limitations. For oral use in dogs only. Repeat at intervals of 6 to 12 hours as required. If necessary, increase dose to a maximum of 0.5 milligram per pound of body weight. Treatment should not normally be required for longer than 7 days. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [47 FR l4702, Apr. 6, 1982, as amended at 53 FR 27851, July 25, 1988]
Title 21: Food and Drugs
PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS
§ 520.246 Butorphanol tartrate tablets.
