21 CFR §520.622c

1. (a)Specifications. Each chewable tablet contains 30, 45, 60, 120, 150, or 180 milligrams of diethylcarbamazine citrate.
2. (b)Sponsors. See drug listing nos. in § 510.600(c) of this chapter for identification of sponsors as follows:
   1. (1)[Reserved]
   2. (2)For 054771, use of 60, 120, or 180 milligram tablets as in paragraph (c)(2)(ii) of this section.
   3. (3)For 061690, use of 45 or 150 milligram tablets as in paragraph (c)(2)(iii) of this section.
   4. (4)For 061133, use of 60-, 120-, or 180-milligram tablets as in paragraph (c)(2)(i) of this section.
   5. (5)For 000061, use of 60-milligram tablets as in paragraph (c)(2)(i) of this section.
   6. (6)For 069043, use of 30, 60, 120, or 180 milligram tablets as in paragraph (c)(2)(i) of this section.
3. (c)Conditions of use—(1) Amount. 3 milligrams per pound of body weight per day for prevention of heartworm disease and control of ascarids; 25 to 50 milligrams per pound of body weight as an aid in treatment of ascarid infections.
   1. (2)Indications for use.
      1. (i)For prevention of heartworm disease (Dirofilaria immitis) in dogs; as an aid in control of ascarids (Toxocara canis) in dogs; as an aid in treatment of ascarid (Toxocara canis and Toxascaris leonina) infections in dogs and cats.
      2. (ii)For prevention of infection with Dirofilaria immitis (heartworm disease) in dogs; as an aid in treatment of ascarid (Toxocara canis and Toxascaris leonina) infections in dogs.
      3. (iii)For prevention of heartworm disease (Dirofilaria immitis) in dogs.
   2. (3)Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.