Code of Federal Regulations Title 21. Food and Drugs § 21.520.998 Fluralaner

(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.

(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), and Rhipicephalus sanguineus (brown dog 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.