(a) Specifications. (1) Each chewable tablet contains 112.5, 250, 500, 1,000, or 1,400 milligrams (mg) fluralaner.

(2) Each chewable tablet contains 45, 100, 200, 400, or 560 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 with food:

(i) Chewable tablets described in paragraph (a)(1) of this section. Administer every 12 weeks, an appropriate combination of tablets to provide a minimum dose of 11.4 mg per pound (lb) (25 mg per kilogram (kg)) body weight. May be administered every 8 weeks in case of potential exposure to Amblyomma americanum ticks.

(ii) Chewable tablets described in paragraph (a)(2) of this section. Administer monthly, an appropriate combination of tablets to provide a minimum dose of 4.5 mg/lb (10 mg/kg) body weight.

(2) Indications for use—(i) Chewable tablets described in paragraph (a)(1) of this section. 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), Rhipicephalus sanguineus (brown dog tick), and Haemaphysalis longicornis (Asian longhorned tick)) for 12 weeks in dogs and puppies 6 months of age and older, and weighing 4.4 lbs or greater; and for the treatment and control of Amblyomma americanum (lone star tick) infestations for 8 weeks in dogs and puppies 6 months of age and older, and weighing 4.4 lbs or greater.

(ii) Chewable tablets described in paragraph (a)(2) of this section. Kills adult fleas; for the treatment and prevention of flea infestations (C. felis), and the treatment and control of tick infestations [I. scapularis (black-legged tick), D. variabilis (American dog tick), and R. sanguineus (brown dog tick)] for 1 month in dogs and puppies 8 weeks of age and older, and weighing 4.4 lbs or greater; and for the treatment and control of A. americanum (lone star tick) infestations for 1 month in dogs and puppies 6 months of age and older, and weighing 4.4 lbs or greater.

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