(a) Specifications. Each chewable tablet contains 112.5, 250, 500, 1000, or 1400 milligrams (mg) fluralaner.

(b) Sponsor. See No. 000061 in § 510.600(c) of this chapter.

(c) Conditions of use in dogs - (1) Amount. Administer orally as a single dose every 12 weeks according to the label dosage schedule to provide a minimum dose of 11.4 mg per pound (/lb) (25 mg per kilogram) body weight. May be administered every 8 weeks in case of potential exposure to Amblyomma americanum ticks.

(2) Indications for use. Kills adult fleas; for the treatment and prevention of flea infestations (Ctenocephalides felis), and the treatment and control of tick infestations [Ixodes scapularis (black-legged tick), Dermacentor variabilis (American dog tick), and Rhipicephalus sanguineus (brown dog tick)] for 12 weeks in dogs and puppies 6 months of age and older, and weighing 4.4 lb or greater; for the treatment and control of A. americanum (lone star tick) infestations for 8 weeks in dogs and puppies 6 months of age and older, and weighing 4.4 lb or greater.

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