(a) Specifications. Each chewable tablet contains:

(1) 9.375 milligrams (mg) afoxolaner, 45 micrograms (mcg) moxidectin, and 18.75 mg pyrantel (as pamoate salt);

(2) 18.75 mg afoxolaner, 90 mcg moxidectin, and 37.5 mg pyrantel (as pamoate salt);

(3) 37.5 mg afoxolaner, 180 mcg moxidectin, and 75 mg pyrantel (as pamoate salt);

(4) 75 mg afoxolaner, 360 mcg moxidectin, and 150 mg pyrantel (as pamoate salt); or

(5) 150 mg afoxolaner, 720 mcg moxidectin, and 300 mg pyrantel (as pamoate salt).

(b) Sponsor. See No. 000010 in § 510.600(c) of this chapter.

(c) Conditions of use—(1) Amount. Administer orally once a month at the minimum dose of 1.14 mg/lb (2.5 mg/kg) afoxolaner, 5.45 mcg/lb (12 mcg/kg) moxidectin, and 2.27 mg/lb (5.0 mg/kg) pyrantel. For heartworm disease prevention, give once monthly for at least 6 months after last exposure to mosquitoes.

(2) Indications for use. For the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment and control of adult hookworm (Ancylostoma caninum, Ancylostoma braziliense, and Uncinaria stenocephala) and roundworm (Toxocara canis and Toxascaris leonina) infections. Kills adult fleas and is indicated for the treatment and prevention of flea infestations (Ctenocephalides felis) and the treatment and control of Ixodes scapularis (black-legged tick), Rhipicephalus sanguineus (brown dog tick), Dermacentor variabilis (American dog tick), Amblyomma americanum (lone star tick), and Haemaphysalis longicornis (longhorned tick) infestations for 1 month in dogs and puppies 8 weeks of age and older, weighing 4 pounds of body weight or greater.

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