21 C.F.R. § 520.1196
Ivermectin and pyrantel tablets.
Cite as 21 C.F.R. § 520.1196 (2026)
(a)
Specifications.
Each chewable tablet contains either 68 micrograms (µg) of ivermectin and 57 milligrams (mg) of pyrantel (as pamoate salt), or 136 µg and 114 mg, or 272 µg and 227 mg, respectively.
(b)
Sponsors.
See Nos. 000010, 051311, and 053701 in § 510.600(c) of this chapter.
(c)
Conditions of use
—(1)
Dogs
—(i)
Amount.
Administer a minimum of 6 µg of ivermectin and 5 mg of pyrantel per kilogram (2.72 µg and 2.27 mg per pound) of body weight monthly.
(ii)
Indications for use.
To prevent canine heartworm disease by eliminating the tissue larval stages of
Dirofilaria immitis
for up to a month (30 days) after infection and treatment and control of adult roundworms
Toxocara canis
and
Toxascaris leonina,
and adult hookworms
Ancylostoma caninum, A. braziliense,
and
Uncinaria stenocephala.
(iii)
Limitations.
Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) [Reserved]
[58 FR 8542, Feb. 16, 1993, as amended at 61 FR 15186, Apr. 5, 1996; 61 FR 59004, Nov. 20, 1996; 62 FR 63270, Nov. 28, 1997; 66 FR 35756, July 9, 2001; 67 FR 21996, May 2, 2002; 68 FR 55823, Sept. 29, 2003; 78 FR 28822, May 20, 2014; 84 FR 39183, Aug. 9, 2019; 88 FR 16547, Mar. 20, 2023; 89 FR 42357, May 15, 2024]
- Cross-references to the CFR
- 510.600