Roxee Medication Guide

Ivermectin 272Mcg, Pyrantel Pamoate 228Mg, Praziquantel 228Mg

Medication reference facts with explicit FDA-approval, off-label, source-limited, and safety context. Roxee does not sell, prescribe, or dispense medications.

Both Reference complete FDA data linked Rx required Chewable tablet Virbac AH, Inc Official label facts Owner quick guide first

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Reference facts

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FDA applications

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Sponsor, product, and application records imported from Animal Drugs @ FDA.

Safety reports

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openFDA reaction terms and case summaries are supporting evidence, not proof of causality.

Source timing details

Reference facts: Source Roxee | Refreshed Aug 6, 2026, 7:46 PM UTC
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Animal Drugs @ FDA: Source FDA | Refreshed Aug 6, 2026, 7:46 PM UTC
Applications/products are imported from FDA export data.
Animal Drugs @ FDA previews: Source FDA | Refreshed Feb 9, 2026, 3:05 AM UTC
Label highlights/doc links are fetched from FDA preview endpoints.

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Ivermectin 272Mcg, Pyrantel Pamoate 228Mg, Praziquantel 228Mg

Drug type: Generic ingredient • Generic profile • No FDA branded products linked

Both Chewable tablet Rx required 100% reference complete

Species: Both

Manufacturer: Virbac AH, Inc

Medication Snapshot

Merged from the current Roxee medication system with field-level provenance, freshness, and completeness tracking.

Ivermectin 272Mcg, Pyrantel Pamoate 228Mg, Praziquantel 228Mg

Prevents canine heartworm disease by eliminating the tissue stage of heartworm larvae ( Dirofilaria immitis ) for 1 month (30 days) after infection and for the treatment and control of roundworm ( Toxocara canis, Toxascaris leonine ), hookworm ( Ancylostoma caninum, Uncinaria stenocephala, Ancylostoma braziliense ) and tapeworm ( Dipylidium caninum, Taenia pisiformis ) infections. 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 ). Species commonly shown: Both, Dog.

Generic name

Ivermectin 272Mcg, Pyrantel Pamoate 228Mg, Praziquantel 228Mg

Brand names

IVERHART MAX®, IVERHART MAX® Chew

Manufacturer

Virbac AH, Inc

Species

Both, Dog

Dosage forms

Chewable tablet, Tablet (Chewable), Chewable Tablets

Prescription

Prescription required

Completeness

100%

Validation

Needs review

Brand names

IVERHART MAX® IVERHART MAX® Chew

Dosage forms

Chewable tablet Tablet (Chewable) Chewable Tablets

Indications / Uses

Prevents canine heartworm disease by eliminating the tissue stage of heartworm larvae ( Dirofilaria immitis ) for 1 month (30 days) after infection and for the treatment and control of roundworm ( Toxocara canis , Toxascaris leonine ), hookworm ( Ancylostoma caninum , Uncinaria stenocephala , Ancylostoma braziliense ) and tapeworm ( Dipylidium caninum , Taenia pisiformis ) infections. 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 ).

Warnings / Contraindications

For oral use in dogs only. IVERHART MAX Chewable Tablets are recommended for dogs 8 weeks of age and older. For dogs over 100 lbs, use the appropriate combination of these Chewable Tablets. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal (U.S.A.) law restricts this drug to use by or on the order of a licensed veterinarian.

For oral use in dogs only. IVERHART MAX Chewable Tablets are recommended for dogs 8 weeks of age and older. For dogs over 100 lbs, use the appropriate combination of these Chewable Tablets. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal (U.S.A.) law restricts this drug to use by or on the order of a licensed veterinarian.

Side Effects

Top reported reactions (openFDA): INEFFECTIVE, HEARTWORM LARVAE, Vomiting, Drug dose omission, Drug dose administration interval too long, Overdose, Lethargy (see also Central nervous system depression in 'Neurological').

FAQ

Both, Dog

Yes. Roxee shows this as prescription-only.

Chewable tablet, Tablet (Chewable), Chewable Tablets

Related Conditions

Heartworm Disease

Source Transparency

Verified source: https://www.roxee.ai/meds/
Verified source: https://animaldrugsatfda.fda.gov
Verified source: https://animaldrugsatfda.fda.gov/adafda/views/#/search
Verified source: https://api.fda.gov/animalandveterinary/event.json
Verified source: https://www.roxee.ai/conditions/
Verified source: https://www.accessdata.fda.gov/spl/data/606cbc0e-c0e0-4b92-bc3b-a7e0e1b3cc7f/606cbc0e-c0e0-4b92-bc3b-a7e0e1b3cc7f.xml
Last refreshed: Aug 6, 2026, 7:46 p.m.
Last verified: Apr 25, 2026, 10:09 a.m.
Validation status: Needs review

Add to My Pet's Medications

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Pet Owner Quick Guide

Start here first for the safest next-step summary before the deeper medication detail.

Used for:

Dosing note:

Exact dosing depends on your pet's species, weight, and health status. Use your veterinarian's instructions for the exact dose and schedule.

What to watch for:

For oral use in dogs only
IVERHART MAX Chewable Tablets are recommended for dogs 8 weeks of age and older
For dogs over 100 lbs, use the appropriate combination of these Chewable Tablets
Federal (U.S.A.) law restricts this drug to use by or on the order of a licensed veterinarian
trouble breathing (1 reports)
Elevated cholesterol (1 reports)

When to call the vet:

Repeated vomiting or diarrhea.
Severe lethargy (hard to wake, very low energy).
Collapse or fainting.
Facial swelling or hives.
Blood in vomit or stool.

Regulatory restrictions are shown in Vet View.

Bloodwork changes are grouped in Vet View.

What to tell or ask your vet today:

Is this medicine the right fit for my pet’s current symptoms?
Which warning signs mean I should call back right away?
How should I handle missed doses or refusal to take the medicine?

Next actions

Talk to a Vet / Find a Vet Near You Save to pet meds Share page Review report evidence

Research brief

Medication Research Insights

A source-aware map of what to know, what is uncertain, and what to verify with your veterinarian.

Source Backed Signals

What to know

Evidence-backed context Limited

Roxee has limited cited overview evidence for Ivermectin 272Mcg, Pyrantel Pamoate 228Mg, Praziquantel 228Mg; use the official documents and your veterinarian's instructions for product-specific decisions.

Source: openFDA case USA-USFDACVM-2025-US-070682

Safety signal coverage Reported signals

32 tracked reaction signals; 32 reported cases; 28 serious reports; 2 species groups. These are reporting and label-derived signals for interpretation with a veterinarian.

Source: openFDA case USA-USFDACVM-2025-US-070682

Interpretation guardrail Not causation

Adverse-event reports help form a watch list, but they do not prove the medication caused the reaction and they are not a risk ranking between medications.

Evidence tension

Stronger signal Label / review

Official labels, package inserts, and reviewed summaries carry more weight than isolated reports.

Source: openFDA case USA-USFDACVM-2025-US-070682

Weaker signal Reported data

Case reports and openFDA terms are useful for pattern awareness, but they are incomplete, can include multiple exposures, and do not estimate an individual pet's probability of harm.

Reaction signal map

Most reported reactions Top terms

Trouble breathing (dyspnea) (1 reports), Elevated creatinine (1 reports), Elevated cholesterol (1 reports), Elevated alanine aminotransferase (1 reports), Dysphoria (1 reports)

Body systems represented Signal grouping

Digestive (3), Skin & allergy (1), Behavior (2), Other (26)

Species and breed lens

Species represented in reports Species lens

Dog (20 reports), Cat (12 reports)

What your vet may verify

Fit for this patient Vet check

Verify whether Ivermectin 272Mcg, Pyrantel Pamoate 228Mg, Praziquantel 228Mg fits the pet's species, current diagnosis, age, weight, organ status, pregnancy/lactation status, and concurrent medications.

Evidence limitations Evidence review

Separate label-backed warnings from adverse-event reports and owner observations before changing the plan.

What to watch next

Watch list Owner-safe

For oral use in dogs only, IVERHART MAX Chewable Tablets are recommended for dogs 8 weeks of age and older, For dogs over 100 lbs, use the appropriate combination of these Chewable Tablets, Federal (U.S.A.) law restricts this drug to use by or on the order of a licensed veterinarian, trouble breathing

Call sooner if Escalation

Repeated vomiting or diarrhea. Severe lethargy (hard to wake, very low energy). Collapse or fainting.

Bottom line: Use this Ivermectin 272Mcg, Pyrantel Pamoate 228Mg, Praziquantel 228Mg brief as a structured watch list and source map, not as a reason to start, stop, or change treatment without your veterinarian.

Vet source depth

openFDA case USA-USFDACVM-2025-US-070682 · adverse_reaction · adverse reactions
Contraindication source · fda_animal_drugs · warnings contraindications
FDA application profile · official_label · quick facts
FDA application profile · official_label · quick facts
Medication usage source · fda_animal_drugs · quick facts
FOI · document · documents
FOI · document · documents
SPL · document · documents

Evidence

Review status / Updated / Sources

Review status: Clinical reviewer not listed

Updated: April 25, 2026, 10:09 AM UTC

Sources:

FDA application profile · official_label
FDA application profile · official_label
Medication usage source · fda_animal_drugs
openFDA case USA-USFDACVM-2025-US-070682 · adverse_reaction
FOI · document

Safety & side effects

Side effects to monitor:

For oral use in dogs only
IVERHART MAX Chewable Tablets are recommended for dogs 8 weeks of age and older
For dogs over 100 lbs, use the appropriate combination of these Chewable Tablets
Federal (U.S.A.) law restricts this drug to use by or on the order of a licensed veterinarian
trouble breathing

Most reported reactions:

Trouble breathing (dyspnea) (1 reports)
Elevated creatinine (1 reports)
Elevated cholesterol (1 reports)

Emergency warning signs:

Repeated vomiting or diarrhea.
Severe lethargy (hard to wake, very low energy).
Collapse or fainting.
Facial swelling or hives.

Talk to a Vet / Find a Vet Near You Start Symptom Intake

Vet Fast Scan

Source-backed clinical checkpoints for quick review.

FDA-labeled species

Dog

Indication / use

Prevents canine heartworm disease by eliminating the tissue stage of heartworm larvae ( Dirofilaria immitis ) for 1 month (30 days) after infection and for the treatment and contr…

Form / route / dose

Form: Chewable Tablets, Tablet (Chewable)
Route: Oral
Confirm product label and patient-specific plan.

Warnings

High: For oral use in dogs only. IVERHART MAX Chewable Tablets are recommended for dogs 8 weeks of age and older. For dogs ov…

Adverse-event caveat

No stored openFDA case explorer rows are linked yet.

Source docs

Quick Facts

Official label facts first, then secondary summaries. Marketing content is separated below.

Species: Both

Manufacturer: Virbac AH, Inc

Form: Chewable Tablets, Tablet (Chewable)

Identifiers:

NADA: 141257 NADA: 141441 NDC Package: 51311-504-02 NDC Package: 51311-505-04 NDC Package: 51311-506-06 NDC Package: 51311-507-08 NDC Product: 51311

Source metadata:

https://animaldrugsatfda.fda.gov/adafda/views/#/home/previewsearch/141257 · official_label · FDA application profile
https://animaldrugsatfda.fda.gov/adafda/views/#/home/previewsearch/141441 · official_label · FDA application profile
https://animaldrugsatfda.fda.gov · fda_animal_drugs · Medication usage source

Warnings / Contraindications

High: For oral use in dogs only. IVERHART MAX Chewable Tablets are recommended for dogs 8 weeks of age and older. For dogs over 100 lbs, use the appropriate combination of these Chewable Tablets. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal (U.S.A.) law restricts this drug to use by or on the order of a licensed veterinarian.

Source metadata:

https://animaldrugsatfda.fda.gov · fda_animal_drugs · Contraindication source

Adverse Reactions

Snapshot first, detailed rows second. This section summarizes signal data and is not a diagnosis.

Tap or hover a reaction to see what it means in plain language.

Tracked signals

Reported cases

Serious reports

Species represented

Grouped by Body System

Digestive (3) · Loss of appetite, Drooling, Diarrhea Skin & allergy (1) · Alopecia NOS Behavior (2) · Behavioral disorder (unspecified), Aggression Other (26) · Trouble breathing (dyspnea), Elevated creatinine, Elevated cholesterol

Most Reported Reactions

Body system	Cases	Species	Serious cases
Other	1	Dog	1
Other	1	Cat	1
Other	1	Dog	1
Other	1	Dog	1
Other	1	Cat	1
Other	1	Cat	1
Other	1	Dog	1
Other	1	Cat	1

Species coverage: Dog (20) Cat (12)

View detailed reaction table

Body system	Species	Seriousness	Frequency	Reports
Other	Dog	Serious	-	1
Digestive	Dog	Non-serious	-	1
Other	Cat	Serious	-	1
Other	Dog	Serious	-	1
Other	Dog	Serious	-	1
Other	Cat	Serious	-	1
Digestive	Dog	Non-serious	-	1
Other	Cat	Serious	-	1
Digestive	Dog	Non-serious	-	1
Other	Dog	Serious	-	1
Other	Cat	Serious	-	1
Other	Cat	Serious	-	1
Other	Dog	Serious	-	1
Other	Cat	Serious	-	1
Other	Dog	Non-serious	-	1
Other	Dog	Serious	-	1
Other	Dog	Serious	-	1
Other	Dog	Serious	-	1
Other	Dog	Serious	-	1
Other	Dog	Serious	-	1
Other	Cat	Serious	-	1
Other	Cat	Serious	-	1
Other	Cat	Serious	-	1
Behavior	Cat	Serious	-	1
Other	Dog	Serious	-	1
Other	Dog	Serious	-	1
Skin & allergy	Dog	Serious	-	1
Behavior	Dog	Serious	-	1
Other	Dog	Serious	-	1
Other	Dog	Serious	-	1
Other	Cat	Serious	-	1
Other	Cat	Serious	-	1

Source metadata:

https://api.fda.gov/animalandveterinary/event.json · adverse_reaction · openFDA case USA-USFDACVM-2025-US-070682

Source Documents

The most useful source links appear first; full previews and metadata stay in the veterinary/professional layer.

Use original documents to confirm product-specific warnings, ingredients, and handling details with your veterinarian.

Iverhart Max® SPL · SPL IVERHART MAX® Chew SPL · SPL IVERHART MAX Chew SPL SPL · Structured Product Label

Full source previews and metadata remain in the veterinary/professional layer.

Owner handouts

No owner handouts linked yet.

Official label / PI

No official label or package insert links yet.

SPL

FOI

Iverhart Max®

SPL · SPL

Open original

FDA Structured Product Label

IVERHART MAX®

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor: Virbac AH, Inc.
NADA: 141-257
Status: RX
Form: Tablet (Chewable)
Route: Oral
Species: Dog

Composition / specifications

Each chewable tablet contains:
(1) 34 micrograms (mcg) ivermectin, 28.5 milligrams (mg) pyrantel pamoate, and 28.5 mg praziquantel;
(2) 68 mcg ivermectin, 57 mg pyrantel pamoate, and 57 mg praziquantel;
(3) 136 mcg ivermectin, 114 mg pyrantel pamoate, and 114 mg praziquantel; or
(4) 272 mcg ivermectin, 228 mg pyrantel pamoate, and 228 mg praziquantel.

Dogs (12.1 - 25 Lbs)

Indication

Prevents canine heartworm disease by eliminating the tissue stage of heartworm larvae (Dirofilaria immitis) for 1 month (30 days) after infection and for the treatment and control of roundworm (Toxocara canis, Toxascaris leonine), hookworm (Ancylostoma caninum, Uncinaria stenocephala, Ancylostoma braziliense) and tapeworm (Dipylidium caninum, Taenia pisiformis) infections.

Dosage

Administered orally at monthly intervals at 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. (One table monthly containing 68 mcg ivermectin, 57 mg pyrantel pamoate, and 57 mg praziquantel)

Limitations

Dogs (6.0 - 12 Lbs)

Indication

Dosage

Administered orally at monthly intervals at 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. (One tablet monthly containing 34 micrograms (mcg) ivermectin, 28.5 milligrams (mg) pyrantel pamoate, and 28.5 mg praziquantel)

Limitations

Dogs (50.1 - 100 Lbs)

Indication

Dosage

Administered orally at monthly intervals at 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. (One tablet monthly containing 272 mcg ivermectin, 228 mg pyrantel pamoate, and 228 mg praziquantel)

Limitations

Dogs (25.1 - 50 Lbs)

Indication

Dosage

Administered orally at monthly intervals at 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. (One tablet monthly containing 136 mcg ivermectin, 114 mg pyrantel pamoate, and 114 mg praziquantel)

Limitations

IVERHART MAX® Chew

SPL · SPL

Open original

FDA Structured Product Label

IVERHART MAX® Chew

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor: Virbac AH, Inc.
NADA: 141-441
Status: RX
Form: Chewable Tablets
Route: Oral
Species: Dog

Composition / specifications

Each chewable tablet contains either: 1) 34 micrograms (mcg) ivermectin, 28.5 milligrams (mg) pyrantel pamoate, and 28.5 mg praziquantel; 2) 68 mcg ivermectin, 57 mg pyrantel pamoate, and 57 mg praziquantel; 3) 136 mcg ivermectin, 114 mg pyrantel pamoate, and 114 mg praziquantel; or 4) 272 mcg ivermectin, 228 mg pyrantel pamoate, and 228 mg praziquantel.

Dogs

Indication

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

Administer orally at monthly intervals at 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:

6.0 to 12 pounds- one tablet containing 34 micrograms (mcg) ivermectin, 28.5 milligrams (mg) pyrantel pamoate, and 28.5 mg praziquantel
12.1 to 25 pounds- one tablet containing 68 mcg ivermectin, 57 mg pyrantel pamoate, and 57 mg praziquantel
25.1 to 50 pounds- one tablet containing 136 mcg ivermectin, 114 mg pyrantel pamoate, and 114 mg praziquantel
50.1 to 100 one tablet containing 272 mcg ivermectin, 228 mg pyrantel pamoate, and 228 mg praziquantel

Limitations

Federal (U.S.A.) law restricts this drug to use by or on the order of a licensed veterinarian.

IVERHART MAX Chew SPL

SPL · Structured Product Label

Open original

FDA Structured Product Label XML for IVERHART MAX Chew. Use the source link for the full official labeling record.

ucm051414.pdf

FOI · FOI

Open original

UCM051416.pdf

FOI · FOI

Open original

FOI Summary oN 141-441 Approved December 11, 2017.pdf

FOI · FOI

Open original

Source metadata:

https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/810 · document · FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/809 · document · FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/217/Iverhart%20Max%C2%AE · document · SPL
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/2901 · document · FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/2797/IVERHART%20MAX%C2%AE%20Chew · document · SPL
https://www.accessdata.fda.gov/spl/data/606cbc0e-c0e0-4b92-bc3b-a7e0e1b3cc7f/606cbc0e-c0e0-4b92-bc3b-a7e0e1b3cc7f.xml · document · Structured Product Label

Veterinary reference (advanced)

Canonical medication sections are above. This legacy block remains available for deeper cross-reference without cluttering the primary workflow.

At a Glance

Quick facts and links to official labeling and safety signals.

Data freshness

Reference facts: Source Roxee | Refreshed Aug 6, 2026, 7:46 PM UTC
The reference fact projection used for browse cards and quick facts.
Animal Drugs @ FDA: Source FDA | Refreshed Aug 6, 2026, 7:46 PM UTC
Applications/products are imported from FDA export data.
Animal Drugs @ FDA previews: Source FDA | Refreshed Feb 9, 2026, 3:05 AM UTC
Label highlights/doc links are fetched from FDA preview endpoints.

Official (FDA)

Identity: Generic ingredient • No FDA branded products linked

No official FDA brand rows linked yet for this ingredient.

Manufacturer mapping: Virbac AH, Inc

Catalog species: Both • FDA-labeled species: Dog

Rx/OTC: RX

Form/route: Chewable Tablets, Tablet (Chewable) • Oral

Applications: NADA 141-257 • NADA 141-441

Documents: 3 (FOI: 3) • SPL: 2 • Label highlights • Official documents

Safety (openFDA)

Top reactions: Dog 0 • Cat 0 • View

Case summaries: 0

openFDA reports are unverified and do not prove causation.

Explore

Related conditions: Heartworm Disease

Linked using: Fda_Label (0.95)

Diagnosis Codes

ICD10_CM: B74.8

Other filariases

Counseling and Monitoring Highlights

Global Pet owner/Vet mode is controlled in the header. This section avoids duplicate in-page persona tabs.

Owner-facing counseling points

For oral use in dogs only. IVERHART MAX Chewable Tablets are recommended for dogs 8 weeks of age and older. For dogs over 100 lbs, use the appropriate combination of these Chewable Tablets. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal (U.S.A.) law restricts this drug to use by or on the order of a licensed veterinarian. (Contraindication, High)

Top reaction signals

Trouble breathing (dyspnea) (1) Elevated creatinine (1) Elevated cholesterol (1) Elevated alanine aminotransferase (1) Dysphoria (1) Dilated pupils (1) Dermal plaque (1) Dehydration (1)

Identifiers & Packages

Normalized identifiers (NDC/NADA/ANADA) and package metadata from regulator listings.

Identifiers

NADA: 141257 NADA: 141441 NDC Package: 51311-504-02 NDC Package: 51311-505-04 NDC Package: 51311-506-06 NDC Package: 51311-507-08 NDC Product: 51311

Package NDC	Product NDC	Status
51311-504-02	51311	-
51311-505-04	51311	-
51311-506-06	51311	-
51311-507-08	51311	-

Enriched Documents

Documents are tiered by source trust: Official, Clinical, Manufacturer, Marketing.

IVERHART MAX Chew SPL • Structured Product Label • Official
FDA Structured Product Label from the electronic animal drug product listing directory.
UCM051416.pdf • FOI summary • Official • June 30, 2026
FDA FOI summary for application 141257
ucm051414.pdf • FOI summary • Official • June 30, 2026
FDA FOI summary for application 141257
FOI Summary oN 141-441 Approved December 11, 2017.pdf • FOI summary • Official • Nov. 19, 2020
FDA FOI summary for application 141441

Data Sources & Change Log

Every non-trivial field is expected to include provenance and update timestamps.

Official 116 Clinical 4 Manufacturer 0 Marketing 0

Current Field Facts

side_effects: Top reported reactions (openFDA): INEFFECTIVE, HEARTWORM LARVAE, Vomiting, Drug dose omission, Drug dose administration interval too long, Overdose, Lethargy (… (Clinical, 2026-04-26)
side_effects: Top reported reactions (openFDA): INEFFECTIVE, HEARTWORM LARVAE, Vomiting, Drug dose omission, Drug dose administration interval too long, Overdose, Lethargy (… (Clinical, 2026-04-25)
side_effects: Top reported reactions (openFDA): INEFFECTIVE, HEARTWORM LARVAE, Vomiting, Drug dose omission, Drug dose administration interval too long, Overdose, Lethargy (… (Clinical, 2026-04-15)
side_effects: Top reported reactions (openFDA): INEFFECTIVE, HEARTWORM LARVAE, Vomiting, Drug dose omission, Drug dose administration interval too long, Overdose, Lethargy (… (Clinical, 2026-04-11)
contraindications: For oral use in dogs only. IVERHART MAX Chewable Tablets are recommended for dogs 8 weeks of age and older. For dogs over 100 lbs, use the appropriate combinat… (Official, 2026-04-26)
contraindications: For oral use in dogs only. IVERHART MAX Chewable Tablets are recommended for dogs 8 weeks of age and older. For dogs over 100 lbs, use the appropriate combinat… (Official, 2026-04-25)
dosage_forms: Chewable tablet (Official, 2026-04-25)
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 infe… (Official, 2026-08-06)
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 infe… (Official, 2026-08-05)
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 infe… (Official, 2026-08-04)
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 infe… (Official, 2026-08-03)
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 infe… (Official, 2026-08-02)
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 infe… (Official, 2026-08-01)
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 infe… (Official, 2026-07-31)
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 infe… (Official, 2026-07-30)
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 infe… (Official, 2026-07-29)
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 infe… (Official, 2026-07-28)
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 infe… (Official, 2026-07-27)
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 infe… (Official, 2026-07-26)
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 infe… (Official, 2026-07-25)

Recent Revisions

side_effects updated 2026-04-26 10:06 by etl_backfill • Backfilled from existing medication fields
contraindications updated 2026-04-26 10:06 by etl_backfill • Backfilled from existing medication fields
usage updated 2026-04-26 10:06 by etl_backfill • Backfilled from existing medication fields
side_effects updated 2026-04-25 10:09 by etl_backfill • Backfilled from existing medication fields
contraindications updated 2026-04-25 10:09 by etl_backfill • Backfilled from existing medication fields
usage updated 2026-04-25 10:09 by etl_backfill • Backfilled from existing medication fields
side_effects updated 2026-04-15 10:04 by etl_backfill • Backfilled from existing medication fields
side_effects updated 2026-04-11 10:05 by etl_backfill • Backfilled from existing medication fields
side_effects updated 2026-02-12 22:44 by etl_backfill • Backfilled from existing medication fields

FDA Products & Applications (Animal Drugs @ FDA)

Official sponsor/proprietary-name/application-status records linked by active ingredient.

Product	Sponsor	Application	Status	Published
IVERHART MAX® RX Ivermectin Praziquantel Pyrantel Pamoate Tablet (Chewable) • Oral Label highlights Official documents	Virbac AH, Inc.	NADA 141-257	Approved	Jun 30, 2026
IVERHART MAX® Chew RX Ivermectin Praziquantel Pyrantel Pamoate Chewable Tablets • Oral Label highlights Official documents	Virbac AH, Inc.	NADA 141-441	Approved	Nov 19, 2020

Data source: FDA Animal Drugs @ FDA (public search export).

What It's For (FDA Label Highlights)

Extracted from FDA Animal Drugs @ FDA product labeling. Always confirm details with your veterinarian.

Species: Dog

Composition / specifications

Dogs (12.1 - 25 Lbs)

Indication

Dosage

Limitations

Dogs (6.0 - 12 Lbs)

Indication

Dosage

Administered orally at monthly intervals at 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. (One tablet monthly containing 34 micrograms (mcg) ivermectin, 28.5 milligrams (mg) pyrantel pamoate, and 28.5 mg praziquantel)

Limitations

Dogs (50.1 - 100 Lbs)

Indication

Dosage

Administered orally at monthly intervals at 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. (One tablet monthly containing 272 mcg ivermectin, 228 mg pyrantel pamoate, and 228 mg praziquantel)

Limitations

Dogs (25.1 - 50 Lbs)

Indication

Dosage

Administered orally at monthly intervals at 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. (One tablet monthly containing 136 mcg ivermectin, 114 mg pyrantel pamoate, and 114 mg praziquantel)

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Dog

Composition / specifications

Dogs

Indication

Dosage

6.0 to 12 pounds- one tablet containing 34 micrograms (mcg) ivermectin, 28.5 milligrams (mg) pyrantel pamoate, and 28.5 mg praziquantel
12.1 to 25 pounds- one tablet containing 68 mcg ivermectin, 57 mg pyrantel pamoate, and 57 mg praziquantel
25.1 to 50 pounds- one tablet containing 136 mcg ivermectin, 114 mg pyrantel pamoate, and 114 mg praziquantel
50.1 to 100 one tablet containing 272 mcg ivermectin, 228 mg pyrantel pamoate, and 228 mg praziquantel

Limitations

Federal (U.S.A.) law restricts this drug to use by or on the order of a licensed veterinarian.

FDA page: Open in Animal Drugs @ FDA

Usage

Prevents canine heartworm disease by eliminating the tissue stage of heartworm larvae ( Dirofilaria immitis ) for 1 month (30 days) after infection and for the treatment and control of roundworm ( Toxocara canis , Toxascaris leonine ), hookworm ( Ancylostoma caninum , Uncinaria stenocephala , Ancylostoma braziliense ) and tapeworm ( Dipylidium caninum , Taenia pisiformis ) infections. 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 ).

Source: FDA Animal Drugs @ FDA • Reference

Contraindications

Top Reported Reactions (openFDA)

De-duplicated reaction terms grouped by body system from FDA openFDA reports (not verified; does not prove causation).

Digestive

Loss of appetite (1) • Dog Drooling (1) • Dog Diarrhea (1) • Dog

Showing top 5 for Digestive.

Skin & allergy

Alopecia NOS (1) • Dog

Showing top 5 for Skin & allergy.

Behavior

Behavioral disorder (1) • Cat Aggression (1) • Dog

Showing top 5 for Behavior.

Other

Trouble breathing (1) • Dog Elevated creatinine (1) • Cat Elevated cholesterol (1) • Dog Elevated alanine aminotransferase (1) • Dog Dysphoria (1) • Cat

Show more (21)

Dilated pupils (1) • Cat Dermal plaque (1) • Dog Dehydration (1) • Cat Decreased activity (1) • Cat Death by euthanasia (1) • Dog Death (1) • Cat Crying (1) • Dog Crust (1) • Dog Crackles on auscultation (1) • Dog Cough (1) • Dog Conjunctivitis (1) • Dog Complication of diabetes (1) • Dog Cardiomyopathy (1) • Cat Cachexia (1) • Cat Bradycardia (1) • Cat Bacterial skin infection NOS (1) • Dog Angioedema (1) • Dog Abnormal ultrasound finding (1) • Dog Abnormal radiograph finding (1) • Dog Abnormal histology NOS (1) • Cat Abnormal cytology (1) • Cat

Showing top 5 for Other.

Data source: FDA openFDA Animal & Veterinary adverse event reports.

Adverse Event Case Summaries (openFDA)

These are individual FDA adverse event reports. They are unverified and do not prove the medication caused the reaction.

No case-level openFDA reports are linked for this medication yet.

Data source: FDA openFDA Animal & Veterinary adverse event reports.

Overdose Information

No approved overdose-management text is linked yet. If overdose is suspected, contact a veterinarian or emergency clinic immediately.

Storage & Handling

No approved storage guidance is linked yet for this ingredient. Use manufacturer packaging and veterinary guidance for handling/storage.

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This medication has not been reviewed by a veterinarian yet.

Medical Disclaimer: The medication details provided on Roxee are for informational purposes only and are not a substitute for professional veterinary advice. Always consult your veterinarian about your pet's specific needs.

Ivermectin 272Mcg, Pyrantel Pamoate 228Mg, Praziquantel 228Mg

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Ivermectin 272Mcg, Pyrantel Pamoate 228Mg, Praziquantel 228Mg

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Ivermectin 272Mcg, Pyrantel Pamoate 228Mg, Praziquantel 228Mg

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Iverhart Max®

IVERHART MAX®

Dogs (12.1 - 25 Lbs)

Dogs (6.0 - 12 Lbs)

Dogs (50.1 - 100 Lbs)

Dogs (25.1 - 50 Lbs)

IVERHART MAX® Chew

IVERHART MAX® Chew

Dogs

IVERHART MAX Chew SPL

ucm051414.pdf

UCM051416.pdf

FOI Summary oN 141-441 Approved December 11, 2017.pdf

At a Glance

Counseling and Monitoring Highlights

Identifiers & Packages

Enriched Documents

Data Sources & Change Log

FDA Products & Applications (Animal Drugs @ FDA)

What It's For (FDA Label Highlights)

IVERHART MAX® • Tablet (Chewable) • Oral

IVERHART MAX® Chew • Chewable Tablets • Oral

Usage

Contraindications

Top Reported Reactions (openFDA)

Adverse Event Case Summaries (openFDA)

Overdose Information

Storage & Handling

Share Your Thoughts