This page reprints a manufacturer label. Everything below in quotation marks is copied from IVERHART MAX ® Chew (ivermectin/pyrantel pamoate/praziquantel), published by FDA and retrieved on 2026-09-16. Nothing has been added, reworded or left out of the sections shown. It is the manufacturer’s label, reproduced as published.
This page reprints the FDA label for IVERHART MAX ® Chew (ivermectin/pyrantel pamoate/praziquantel) by Virbac AH, Inc, a ivermectin, pyrantel and praziquantel product labelled for dogs. The sections below are copied from that label without change, with the set id and the date it was retrieved from DailyMed.
The label
Product: IVERHART MAX ® Chew (ivermectin/pyrantel pamoate/praziquantel). Manufacturer: Virbac AH, Inc. FDA Structured Product Label set id 4460220b-692d-49aa-b840-54a2711536ab. Label effective 2024-02-12. Retrieved 2026-09-16 from the DailyMed animal label release, and readable on DailyMed.
Indications
For use in dogs to prevent canine heartworm disease by eliminating the tissue stage of heartworm larvae ( Dirofilaria immitis ) for a month (30 days) after infection and for the treatment and control of roundworms ( Toxocara canis, Toxascaris leonina ), hookworms ( Ancylostoma caninum, Uncinaria stenocephala, Ancylostoma braziliense ), and tapeworms ( Dipylidium caninum, Taenia pisiformis ).
Dosage and Administration
IVERHART MAX Chew should be administered orally at monthly intervals and the recommended minimum dose level of 6 mcg of ivermectin per kilogram (2.72 mcg/ lb), 5 mg of pyrantel (as pamoate salt) per kg (2.27 mg/lb), and 5 mg of praziquantel per kg (2.27 mg/lb) of body weight, as follows: Dosing Schedule Dog Weight Pounds Chew per Month Chew Size Ivermectin Content Pyrantel Pamoate Content Praziquantel Content 6.0 to 12 1 Toy 34 mcg 28.5 mg 28.5 mg 12.1 to 25 1 Small 68 mcg 57 mg 57 mg 25.1 to 50 1 Medium 136 mcg 114 mg 114 mg 50.1 to 100 1 Large 272 mcg 228 mg 228 mg IVERHART MAX Chew is recommended for dogs 8 weeks of age or older. For dogs over 100 lbs, use the appropriate combination of these chews. Remove only one dose at a time from the packaging. Return the remaining chew(s) to their box to protect from light. The chew can be offered to the dog by hand or added, intact, to a small amount of dog food. Care should be taken to ensure that the dog consumes the complete dose. The treated dog should be observed for a few minutes after administration to confirm that none of the dose has been lost or rejected. If it is suspected that any of the dose has been lost, redosing is recommended. IVERHART MAX Chew should be given at monthly intervals during the period of the year when mosquitoes (vectors), potentially carrying infective heartworm larvae, are active. The initial dose must be given within a month (30 days) after the dog’s first exposure to mosquitoes. The final dose must be given within a month (30 days) after the dog’s last exposure to mosquitoes. When replacing another heartworm preventative product in a heartworm disease prevention program, the first dose of IVERHART MAX Chew must be given within a month (30 days) after the last dose of the former medication. A heartworm test should be performed prior to and 6 months after switching heartworm preventative products. If the interval between doses exceeds a month (30 days), the effectiveness of ivermectin can be reduced. Therefore, for optimal performance, the chew must be given once a month on or about the same day of the month. If treatment is delayed, whether by a few days or many, immediate treatment with IVERHART MAX Chew and resumption of the recommended dosing regimen will minimize the opportunity for the development of adult heartworms.
Warnings
For use in dogs only. Keep this and all drugs out of reach of children and pets. In safety studies with ivermectin/pyrantel pamoate/praziquantel tablets, testicular hypoplasia was observed in some dogs receiving 3 and 5 times the maximum recommended dose monthly for 6 months (see Animal Safety). In case of ingestion by humans, clients should be advised to contact a physician immediately. Physicians may contact a Poison Control Center for advice concerning cases of ingestion by humans.
Precautions
Use with caution in sick, debilitated, or underweight animals and dogs weighing less than 10 lbs (see Animal Safety). The safe use of this drug has not been evaluated in pregnant or lactating bitches. All dogs should be tested for existing heartworm infection before and 6 months after starting treatment with IVERHART MAX Chew, which is not effective against adult Dirofiliaria immitis . Infected dogs should be treated to remove adult heartworms and microfilariae before initiating a heartworm prevention program. While some microfilariae may be killed by the ivermectin in IVERHART MAX Chew at the recommended dose level, IVERHART MAX Chew is not effective for microfilariae clearance. A mild hypersensitivity-type reaction, presumably due to dead or dying microfilariae and particularly involving a transient diarrhea, has been observed in clinical trials with ivermectin alone after treatment of some dogs that have circulating microfilariae.
Adverse Reactions
In a field study with IVERHART MAX Chew, self-limiting adverse reactions, including vomiting, diarrhea, lethargy, difficulty swallowing, excessive salivation, increased water consumption, and coughing were reported. Self-limiting adverse reactions, including lethargy, limpness, salivation, shaking, diarrhea, decreased appetite, licking lips, and belching were reported between 20 minutes and 72 hours following treatment in a field study with ivermectin/pyrantel pamoate/praziquantel tablets. In field studies with ivermectin/pyrantel/praziquantel pamoate tablets, vomiting or diarrhea within 24 hours of dosing was rarely observed (1.1% of administered doses). The following adverse reactions have been reported in dogs following the use of ivermectin products: depression/lethargy, vomiting,anorexia, diarrhea, mydriasis, ataxia, staggering, convulsions, and hypersalivation. To report suspected adverse events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact Virbac AH, Inc. at 1-800-338-3659 or us.virbac.com. For additional information about adverse drug experience reporting for animal drugs, contact the FDA at 1-888-FDA-VETS or www.fda.gov/reportanimalae. Effectiveness: Prevention of the tissue larval stage of heartworm (Dirofilaria immitis) and the elimination of the adult stage of hookworm ( Ancylostoma caninum, Uncinaria stenocephala, Anyclostoma braziliense ), roundworm ( Toxocara canis, Toxascaris leonina ), and tapeworm ( Dipylidium caninum, Taenia pisiformis ) infections in dogs was demonstrated in well-controlled laboratory studies. Palatability: In a field study of 132 dogs, IVERHART MAX Chew was offered once monthly for 3 months. The dogs voluntarily consumed 86.3% of the doses from the owner’s hand or from a bowl within 5 minutes, 13.0% accepted the dose when it was offered in food or administered by placing in the back of the dog’s tongue (pilling), and 0.7% of the doses were unable to be administered.
Description
IVERHART MAX® Chew is a combination of three anthelmintics (ivermectin/pyrantel pamoate/praziquantel). The chews are available in four sizes in color-coded packages for oral administration to dogs according to their weight (see Dosage and Administration ).
Storage
Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F to 86°F). Protect product from light.
FDA adverse event reports
The FDA Center for Veterinary Medicine publishes the adverse event reports it receives through openFDA. The counts below are the reports naming ivermectin and pyrantel and praziquantel as an active ingredient for each species this label names, as returned on 2026-09-16, coded by the VeDDRA reaction term the reporter chose. Reactions are counted per report, so one report can appear under several terms.
These are counts, not rates. Reporting is voluntary, the number of animals treated is not known, and a widely used product accumulates reports for that reason alone. A report records that an event followed a dose; it does not establish that the product caused it. The counts say nothing about how one product compares with another.
Dogs: 9,758 reports
| VeDDRA reaction term | Reports |
|---|---|
| Vomiting | 3,520 |
| INEFFECTIVE, HEARTWORM LARVAE | 1,468 |
| Lack of efficacy (endoparasite) - heartworm | 1,161 |
| Diarrhoea | 931 |
| Lack of efficacy (endoparasite) - hookworm | 902 |
| Lack of efficacy - NOS | 880 |
| Lethargy (see also Central nervous system depression in 'Neurological') | 747 |
| INEFFECTIVE, ASCARIDS NOS | 495 |
| Lack of efficacy (endoparasite) - tapeworm | 420 |
| Depression | 228 |
| Overdose | 204 |
| Anorexia | 170 |
| Seizure NOS | 162 |
| Behavioural disorder NOS | 149 |
| Shaking | 133 |
Outcome as recorded by the reporter: Outcome Unknown 4,018; Recovered/Normal 3,452; Ongoing 321; Died 109; Recovered with Sequela 88; Euthanized 41.
Queries: reports, reactions, outcomes. Dataset: openFDA Animal and Veterinary Adverse Event Reports.
Sources
- IVERHART MAX ® Chew (ivermectin/pyrantel pamoate/praziquantel)FDA · retrieved 2026-09-16
“IVERHART MAX Chew should be administered orally at monthly intervals and the recommended minimum dose level of 6 mcg of ivermectin per kilogram (2.72 mcg/ lb), 5 mg of pyrantel (as pamoate salt) per kg (2.27 mg/lb), and 5 mg of praziquantel per kg (2.27 mg/lb) of body weight, as follows: Dosing Schedule Dog Weight Pounds Chew per Month Chew Size Ivermectin Content Pyrantel Pamoate Content Praziquantel Content 6.0 to 12 1 Toy 34 mcg 28.5 mg 28.5 mg 12.1 to 25 1 Small 68 mcg 57 mg 57 mg 25.1 to 50 1 Medium 136 mcg 114 mg 114 mg 50.1 to 100 1 Large 272 mcg 228 mg 228 mg IVERHART MAX Chew is recommended for dogs 8 weeks of age or older.” (Dosage and Administration)
- openFDA Animal and Veterinary Adverse Event ReportsFDA · retrieved 2026-09-16
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