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Roxee Medication Guide

Ivermectin/Pyrantel Pamoate Chewable 68Mcg/163Mg

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 Tablet (Chewable) Multiple FDA labelers Official label facts Owner quick guide first
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Data freshness

Reference facts
Reference refreshed
Jun 22, 2026, 10:40 a.m.

These are the reference facts Roxee uses on browse cards and quick facts.

FDA applications
FDA application data refreshed
Jun 22, 2026, 10:40 a.m.

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

Safety reports
Safety data refreshed
Jun 20, 2026, 8:54 p.m.

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

Source timing details
Source timing details
  • Reference facts: Source Roxee | Refreshed Jun 22, 2026, 10:40 AM UTC
    The reference fact projection used for browse cards and quick facts.
  • Animal Drugs @ FDA: Source FDA | Refreshed Jun 22, 2026, 10:40 AM 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.
  • openFDA reaction terms: Source FDA openFDA | Refreshed Jun 22, 2026, 10:45 AM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed Jun 22, 2026, 10:45 AM UTC
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Ivermectin/Pyrantel Pamoate Chewable 68Mcg/163Mg

Ivermectin/Pyrantel Pamoate Chewable 68Mcg/163Mg

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

Both Tablet (Chewable) Rx required 100% reference complete

Species: Both

Manufacturer: Multiple FDA labelers

Medication Snapshot

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

Ivermectin/Pyrantel Pamoate Chewable 68Mcg/163Mg

To prevent canine heartworm diseases by eliminating the tissue stage of heartworm larvae ( Dirofilaria immitis ) for a month (30 days) after infection. For the treatment and control of ascarids ( Toxocara canis, Toxascaris leonine ), and hookworms ( Ancylostoma caninum, A braziliense, and Uncinaria stenocephala ). Ivermectin: to prevent canine heartworm diseases by eliminating the tissue larval stage of Dirofilaria immitis for a month (30 days) after infection. Pyrantel pamoate: for the treatment and control of adult Toxocara canis, Toxascaris leonina, Ancylostoma caninum, A braziliense, and Uncinaria stenocephala. Species commonly shown: Both, Dog, Excluding Under 6 Weeks Age, Dog.

Generic name
Ivermectin/Pyrantel Pamoate Chewable 68Mcg/163Mg
Brand names
Heartgard® Plus, Tri-Heart Plus Chewable Tablets
Manufacturer
Multiple FDA labelers
Species
Both, Dog
Dosage forms
Tablet (Chewable)
Prescription
Prescription required
Completeness
100%
Validation
Needs review
Brand names
Heartgard® Plus Tri-Heart Plus Chewable Tablets
Dosage forms
Tablet (Chewable)

Indications / Uses

To prevent canine heartworm diseases by eliminating the tissue stage of heartworm larvae ( Dirofilaria immitis ) for a month (30 days) after infection. For the treatment and control of ascarids ( Toxocara canis , Toxascaris leonine ), and hookworms ( Ancylostoma caninum , A braziliense , and Uncinaria stenocephala ). Ivermectin: to prevent canine heartworm diseases by eliminating the tissue larval stage of Dirofilaria immitis for a month (30 days) after infection. Pyrantel pamoate: for the treatment and control of adult Toxocara canis, Toxascaris leonina, Ancylostoma caninum, A braziliense, and Uncinaria stenocephala.

Warnings / Contraindications

Use monthly. Recommended for dogs 6 weeks of age or older. Federal law restricts this drug to use by or on the order of a veterinarian. All dogs should be tested for existing heartworm infection before starting treatment with HEARTGARD Plus which is not effective against adult D. immitis . Infected dogs must be treated to remove adult heartworms and microfilariae before initiating a program with HEARTGARD Plus. Use monthly. Recommended for dogs 6 weeks of age or older. Federal law restricts this drug to use by or on the order of a veterinarian.

  • Use monthly. Recommended for dogs 6 weeks of age or older. Federal law restricts this drug to use by or on the order of a veterinarian. All dogs should be tested for existing heartworm infection before starting treatment with HEARTGARD Plus which is not effective against adult D. immitis . Infected dogs must be treated to remove adult heartworms and microfilariae before initiating a program with HEARTGARD Plus. Use monthly. Recommended for dogs 6 weeks of age or older. Federal law restricts this drug to use by or on the order of a veterinarian.

Side Effects

Top reported reactions (openFDA): Vomiting, Lethargy (see also Central nervous system depression in 'Neurological'), Diarrhoea, Lack of efficacy (endoparasite) - heartworm, Emesis (multiple), Decreased appetite.

FAQ

Both, Dog, Excluding Under 6 Weeks Age, Dog

Yes. Roxee shows this as prescription-only.

Tablet (Chewable)

Related Conditions

Heartworm Disease

Source Transparency

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Pet Owner Quick Guide

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

Used for:

Ivermectin: to prevent canine heartworm diseases by eliminating the tissue larval stage of Dirofilaria immitis for a month (30 days) after infection. Pyrantel pamoate: for the treatment and control of adult Toxocara cani...

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:

  • Use monthly
  • Recommended for dogs 6 weeks of age or older
  • All dogs should be tested for existing heartworm infection before starting treatment with HEARTGARD Plus which is not effective against adult D
  • immitis
  • Infected dogs must be treated to remove adult heartworms and microfilariae before initiating a program with HEARTGARD Plus
  • trouble breathing (1 reports)
  • Elevated serum alkaline phosphatase (1 reports)
  • Elevated globulins (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.

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/Pyrantel Pamoate Chewable 68Mcg/163Mg; 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 serum alkaline phosphatase (1 reports), Elevated globulins (1 reports), Elevated gamma-glutamyl transferase (1 reports), Elevated creatinine (1 reports)

Body systems represented Signal grouping

Digestive (3), Skin & allergy (1), Behavior (1), Other (27)

Explore supporting adverse reports

Species and breed lens

Species represented in reports Species lens

Dog (20 reports), Cat (12 reports)

Breed metadata in reports Metadata only

Dog (unknown) (1), Beagle (1), Spaniel - King Charles Cavalier (1), Collie - Border (1). These are report metadata, not proof that a breed is at higher risk.

What your vet may verify

Fit for this patient Vet check

Verify whether Ivermectin/Pyrantel Pamoate Chewable 68Mcg/163Mg 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

Use monthly, Recommended for dogs 6 weeks of age or older, All dogs should be tested for existing heartworm infection before starting treatment with HEARTGARD, immitis, Infected dogs must be treated to remove adult heartworms and microfilariae before initiating a progr

Call sooner if Escalation

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

Bottom line: Use this Ivermectin/Pyrantel Pamoate Chewable 68Mcg/163Mg 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
  1. openFDA case USA-USFDACVM-2025-US-070682 · adverse_reaction · adverse reactions
  2. Contraindication source · fda_animal_drugs · warnings contraindications
  3. FDA application profile · official_label · quick facts
  4. FDA application profile · official_label · quick facts
  5. Medication usage source · fda_animal_drugs · quick facts
  6. FOI · document · documents
  7. SPL · document · documents
  8. FOI · document · documents

Evidence

Review status / Updated / Sources

Review status: Clinical reviewer not listed

Updated: April 22, 2026, 10:14 AM UTC

Sources:
Safety & side effects

Side effects to monitor:

  • Use monthly
  • Recommended for dogs 6 weeks of age or older
  • All dogs should be tested for existing heartworm infection before starting treatment with HEARTGARD Plus which is not effective against adult D
  • immitis
  • Infected dogs must be treated to remove adult heartworms and microfilariae before initiating a program with HEARTGARD Plus

Most reported reactions:

  • Trouble breathing (dyspnea) (1 reports)
  • Elevated serum alkaline phosphatase (1 reports)
  • Elevated globulins (1 reports)
Explore reported case details

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
Ivermectin: to prevent canine heartworm diseases by eliminating the tissue larval stage of Dirofilaria immitis for a month (30 days) after infection. Pyrantel pamoate: for the tre…
Form / route / dose
Form: Tablet (Chewable)
Route: Oral
Confirm product label and patient-specific plan.
Warnings
  • High: Use monthly. Recommended for dogs 6 weeks of age or older. Federal law restricts this drug to use by or on the order of…
Adverse-event caveat
openFDA adverse-event cases are reported signals. They are not verified, do not prove causation, and do not estimate a pet's individual risk.
Source docs

Quick Facts

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

Species: Both
Manufacturer: Multiple FDA labelers
Form: Tablet (Chewable)
Identifiers:
ANADA: 200338 NADA: 140971 NDC Package: 0010-4012-01 NDC Package: 0010-4012-02 NDC Package: 0010-4012-03 NDC Package: 0010-4012-04 NDC Package: 0010-4013-01 NDC Package: 0010-4013-02 NDC Package: 0010-4013-03 NDC Package: 0010-4013-04 NDC Package: 0010-4014-01 NDC Package: 0010-4014-02 NDC Package: 0010-4014-03 NDC Package: 0010-4014-04 NDC Package: 0061-1339-03 NDC Package: 0061-1346-04 NDC Package: 0061-1353-03 NDC Package: 13985-951-25 NDC Package: 13985-969-50 NDC Package: 13985-970-10
Source metadata:

Warnings / Contraindications

Use monthly. Recommended for dogs 6 weeks of age or older. Federal law restricts this drug to use by or on the order of a veterinarian. All dogs should be tested for existing heartworm infection before starting treatment with HEARTGARD Plus which is not effective against adult D. immitis . Infected dogs must be treated to remove adult heartworms and microfilariae before initiating a program with HEARTGARD Plus. Use monthly. Recommended for dogs 6 weeks of age or older. Federal law restricts this drug to use by or on the order of a veterinarian.

  • High: Use monthly. Recommended for dogs 6 weeks of age or older. Federal law restricts this drug to use by or on the order of a veterinarian. All dogs should be tested for existing heartworm infection before starting treatment with HEARTGARD Plus which is not effective against adult D. immitis . Infected dogs must be treated to remove adult heartworms and microfilariae before initiating a program with HEARTGARD Plus. Use monthly. Recommended for dogs 6 weeks of age or older. Federal law restricts this drug to use by or on the order of a veterinarian.
Source metadata:

Adverse Reactions

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

Reported case explorer

Filter stored openFDA reports by pet and report attributes. Counts describe reports in this data set, not risk.

Clear filters
openFDA adverse-event cases are reported signals. They are not verified, do not prove causation, and do not estimate a pet's individual risk.
Stored reports
12
Matching reports
2
Active filters
2
Selected filters
Reaction: Lack of efficacy (endoparasite) - heartworm Clear Body system: Effectiveness Clear
Reset
Drill into common report signals
Lack of efficacy (bacteria) - Anaplasma (2) Lack of efficacy (endoparasite) - heartworm (2) Vomiting (2) Anorexia (1) Effectiveness (6) Digestive (4) Other (4) Behavior (1)
Showing up to 50 matching reports.

USA-USFDACVM-2025-US-074655

Received 2025-12-18 · MSK · MSK

Non-serious
Species
Dog
Breed
Collie - Border
Size / weight
25-49 lb (19.051 Kilogram)
Age
8+ years (1 Year)
Sex
Male Neutered
Region
USA
Reactions
Lack of efficacy (endoparasite) - heartworm
Body systems
Effectiveness
Outcomes
Ongoing

USA-USFDACVM-2025-US-073494

Received 2025-12-15 · MSK · MSK

Serious
Species
Dog
Breed
Terrier - Yorkshire
Size / weight
10-24 lb (6.804 Kilogram)
Age
4-7 years (4 Year)
Sex
Male Neutered
Region
USA
Reactions
Lack of efficacy (endoparasite) - heartworm
Body systems
Effectiveness
Outcomes
Ongoing

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

Tracked signals
32
Reported cases
32
Serious reports
28
Species represented
2
Grouped by Body System
Digestive (3) · Loss of appetite, Drooling, Diarrhea Skin & allergy (1) · Alopecia NOS Behavior (1) · Behavioral disorder (unspecified) Other (27) · Trouble breathing (dyspnea), Elevated serum alkaline phosphatase, Elevated globulins
Most Reported Reactions
Reaction Body system Cases Species Serious cases
Other 1 Dog 1
Other 1 Dog 1
Other 1 Cat 1
Other 1 Dog 1
Other 1 Cat 1
Other 1 Dog 1
Other 1 Dog 1
Other 1 Dog 1

Species coverage: Dog (20) Cat (12)

View detailed reaction table
Reaction Body system Species Seriousness Frequency Reports
Other Dog Serious - 1
Digestive Dog Non-serious - 1
Other Dog Serious - 1
Other Cat Serious - 1
Other Dog Serious - 1
Other Cat Serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Digestive Dog Non-serious - 1
Digestive Dog Non-serious - 1
Other Dog Serious - 1
Other Cat Serious - 1
Other Cat 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
Other Dog Serious - 1
Skin & allergy Dog Serious - 1
Other Dog Serious - 1
Other Cat Serious - 1
Other Cat Serious - 1
Other Cat Serious - 1
Source metadata:

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.

Tri-Heart Plus Chewable Tablets SPL · SPL Heartgard® Plus SPL · SPL HEARTGARD Plus SPL SPL · Structured Product Label

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

Owner handouts

0
No owner handouts linked yet.

Official label / PI

0
No official label or package insert links yet.

SPL

6

FOI

3

Tri-Heart Plus Chewable Tablets

SPL · SPL

Open original
FDA Structured Product Label

Tri-Heart Plus Chewable Tablets

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

Sponsor
Diamond Animal Health, Inc.
ANADA
200-338
Status
RX
Form
Tablet (Chewable)
Route
Oral
Species
Dog
Composition / specifications
Each chewable tablet contains either 68 micrograms of ivermectin and 57 milligrams of pyrantel (as pamoate salt), or 136 micrograms ivermectin and 114 milligrams pyrantel, or 272 micrograms and 227 milligrams, respectively.

Dogs

Indication
Ivermectin: to prevent canine heartworm diseases by eliminating the tissue larval stage of Dirofilaria immitis for a month (30 days) after infection. Pyrantel pamoate: for the treatment and control of adult Toxocara canis, Toxascaris leonina, Ancylostoma caninum, A braziliense, and Uncinaria stenocephala.
Dosage
A minimum of 6 micrograms of ivermectin and 5 milligrams of pyrantel (as pamoate salt) per kilogram (2.72 micrograms and 2.27 milligrams per pound) of body weight. up to 25 pounds: 68 micrograms ivermectin and 57 milligrams pyrantel pamoate 26 to 50 pounds: 136 micrograms ivermectin and 114 milligrams pyrantel pamoate 51 to 100 pounds: 272 micrograms ivermectin and 227 milligrams pyrantel pamoate
Limitations
Use monthly. Recommended for dogs 6 weeks of age or older. Federal law restricts this drug to use by or on the order of a veterinarian.

Heartgard® Plus

SPL · SPL

Open original
FDA Structured Product Label

Heartgard® Plus

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

Sponsor
Boehringer Ingelheim Animal Health USA, Inc.
NADA
140-971
Status
RX
Form
Tablet (Chewable)
Route
Oral
Species
Dog
Composition / specifications
Each chewable tablet contains either 68 micrograms of ivermectin and 57 milligrams of pyrantel (as pamoate salt), or 136 micrograms ivermectin and 114 milligrams pyrantel, or 272 micrograms and 227 milligrams, respectively.

Dogs

Indication
To prevent canine heartworm diseases by eliminating the tissue stage of heartworm larvae (Dirofilaria immitis) for a month (30 days) after infection. For the treatment and control of ascarids (Toxocara canis, Toxascaris leonine), and hookworms (Ancylostoma caninum, A braziliense, and Uncinaria stenocephala).
Dosage
A minimum of 6 micrograms of ivermectin and 5 milligrams of pyrantel (as pamoate salt) per kilogram (2.72 micrograms and 2.27 milligrams per pound) of body weight. up to 25 pounds: 68 micrograms ivermectin and 57 milligrams pyrantel pamoate 26 to 50 pounds: 136 micrograms ivermectin and 114 milligrams pyrantel pamoate 51 to 100 pounds: 272 micrograms ivermectin and 227 milligrams pyrantel pamoate
Limitations
Use monthly. Recommended for dogs 6 weeks of age or older. Federal law restricts this drug to use by or on the order of a veterinarian. All dogs should be tested for existing heartworm infection before starting treatment with HEARTGARD Plus which is not effective against adult D. immitis. Infected dogs must be treated to remove adult heartworms and microfilariae before initiating a program with HEARTGARD Plus.

HEARTGARD Plus SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for HEARTGARD Plus. Use the source link for the full official labeling record.

TriHeart Plus SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for TriHeart Plus. Use the source link for the full official labeling record.

Iverhart Plus SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for Iverhart Plus. Use the source link for the full official labeling record.

VetriShield Plus SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for VetriShield Plus. Use the source link for the full official labeling record.

ucm061802.pdf

FOI · FOI

Open original

UCM487711.pdf

FOI · FOI

Open original

UCM487710.pdf

FOI · FOI

Open original
Source metadata:
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 Jun 22, 2026, 10:40 AM UTC
    The reference fact projection used for browse cards and quick facts.
  • Animal Drugs @ FDA: Source FDA | Refreshed Jun 22, 2026, 10:40 AM 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.
  • openFDA reaction terms: Source FDA openFDA | Refreshed Jun 22, 2026, 10:45 AM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed Jun 22, 2026, 10:45 AM UTC
Official (FDA)
Identity: Generic ingredient • No FDA branded products linked
No official FDA brand rows linked yet for this ingredient.
Manufacturer mapping: Multiple FDA labelers
Case-reported brands (openFDA): MSK
Catalog species: Both • FDA-labeled species: Dog
Rx/OTC: RX
Form/route: Tablet (Chewable) • Oral
Applications: ANADA 200-338 • NADA 140-971
Documents: 3 (FOI: 3) • SPL: 2 • Label highlights • Official documents
Safety (openFDA)
Top reactions: Dog 18 • Cat 0 • View
Case summaries: 12 (showing 8) • View
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
  • Use monthly. Recommended for dogs 6 weeks of age or older. Federal law restricts this drug to use by or on the order of a veterinarian. All dogs should be tested for existing heartworm infection before starting treatment with HEARTGARD Plus which is not effective against adult D. immitis . Infected dogs must be treated to remove adult heartworms and microfilariae before initiating a program with HEARTGARD Plus. Use monthly. Recommended for dogs 6 weeks of age or older. Federal law restricts this drug to use by or on the order of a veterinarian. (Contraindication, High)
Top reaction signals
Trouble breathing (dyspnea) (1) Elevated serum alkaline phosphatase (1) Elevated globulins (1) Elevated gamma-glutamyl transferase (1) Elevated creatinine (1) Elevated cholesterol (1) Elevated alanine aminotransferase (1) Dermal plaque (1)

Identifiers & Packages

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

Identifiers
ANADA: 200338 NADA: 140971 NDC Package: 0010-4012-01 NDC Package: 0010-4012-02 NDC Package: 0010-4012-03 NDC Package: 0010-4012-04 NDC Package: 0010-4013-01 NDC Package: 0010-4013-02 NDC Package: 0010-4013-03 NDC Package: 0010-4013-04 NDC Package: 0010-4014-01 NDC Package: 0010-4014-02 NDC Package: 0010-4014-03 NDC Package: 0010-4014-04 NDC Package: 0061-1339-03 NDC Package: 0061-1346-04 NDC Package: 0061-1353-03 NDC Package: 13985-951-25 NDC Package: 13985-969-50 NDC Package: 13985-970-10 NDC Package: 51311-170-20 NDC Package: 51311-171-20 NDC Package: 51311-172-20 NDC Product: 0010
Package NDC Product NDC Form / Route Status
0010-4012-01 0010 -
0010-4012-02 0010 -
0010-4012-03 0010 -
0010-4012-04 0010 -
0010-4013-01 0010 -
0010-4013-02 0010 -
0010-4013-03 0010 -
0010-4013-04 0010 -
0010-4014-01 0010 -
0010-4014-02 0010 -
0010-4014-03 0010 -
0010-4014-04 0010 -
0061-1339-03 0061 -
0061-1346-04 0061 -
0061-1353-03 0061 -
13985-951-25 13985 -
13985-969-50 13985 -
13985-970-10 13985 -
51311-170-20 51311 -
51311-171-20 51311 -

Enriched Documents

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

  • HEARTGARD Plus SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • TriHeart Plus SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Iverhart Plus SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • VetriShield Plus SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • ucm061802.pdf • FOI summary • Official • Feb. 8, 2024
    FDA FOI summary for application 200338
  • UCM487710.pdf • FOI summary • Official • June 1, 2016
    FDA FOI summary for application 140971
  • UCM487711.pdf • FOI summary • Official • June 1, 2016
    FDA FOI summary for application 140971

Data Sources & Change Log

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

Official 84 Clinical 8 Manufacturer 0 Marketing 0
Current Field Facts
  • monitoring: Monitor blood glucose and ketones, hydration status, appetite, and clinical response at regular intervals. (Clinical, 2026-04-21)
  • monitoring: Monitor blood glucose and ketones, hydration status, appetite, and clinical response at regular intervals. (Clinical, 2026-04-20)
  • monitoring: Monitor blood glucose and ketones, hydration status, appetite, and clinical response at regular intervals. (Clinical, 2026-04-19)
  • monitoring: Monitor blood glucose and ketones, hydration status, appetite, and clinical response at regular intervals. (Clinical, 2026-04-17)
  • monitoring: Monitor blood glucose and ketones, hydration status, appetite, and clinical response at regular intervals. (Clinical, 2026-04-16)
  • monitoring: Monitor blood glucose and ketones, hydration status, appetite, and clinical response at regular intervals. (Clinical, 2026-04-16)
  • monitoring: Monitor blood glucose and ketones, hydration status, appetite, and clinical response at regular intervals. (Clinical, 2026-04-15)
  • side_effects: Top reported reactions (openFDA): Vomiting, Lethargy (see also Central nervous system depression in 'Neurological'), Diarrhoea, Lack of efficacy (endoparasite)… (Clinical, 2026-04-11)
  • contraindications: Use monthly. Recommended for dogs 6 weeks of age or older. Federal law restricts this drug to use by or on the order of a veterinarian. All dogs should be test… (Official, 2026-04-22)
  • indications: Ivermectin (To prevent canine heartworm disease by eliminating the tissue larval stages of Dirofilaria immitis for a month (30 days) after infection), pyrantel… (Official, 2026-06-22)
  • indications: Ivermectin (To prevent canine heartworm disease by eliminating the tissue larval stages of Dirofilaria immitis for a month (30 days) after infection), pyrantel… (Official, 2026-06-22)
  • indications: Ivermectin (To prevent canine heartworm disease by eliminating the tissue larval stages of Dirofilaria immitis for a month (30 days) after infection), pyrantel… (Official, 2026-06-21)
  • indications: Ivermectin (To prevent canine heartworm disease by eliminating the tissue larval stages of Dirofilaria immitis for a month (30 days) after infection), pyrantel… (Official, 2026-06-20)
  • indications: Ivermectin (To prevent canine heartworm disease by eliminating the tissue larval stages of Dirofilaria immitis for a month (30 days) after infection), pyrantel… (Official, 2026-06-13)
  • indications: Ivermectin (To prevent canine heartworm disease by eliminating the tissue larval stages of Dirofilaria immitis for a month (30 days) after infection), pyrantel… (Official, 2026-06-12)
  • indications: Ivermectin (To prevent canine heartworm disease by eliminating the tissue larval stages of Dirofilaria immitis for a month (30 days) after infection), pyrantel… (Official, 2026-06-12)
  • indications: Ivermectin (To prevent canine heartworm disease by eliminating the tissue larval stages of Dirofilaria immitis for a month (30 days) after infection), pyrantel… (Official, 2026-06-11)
  • indications: Ivermectin (To prevent canine heartworm disease by eliminating the tissue larval stages of Dirofilaria immitis for a month (30 days) after infection), pyrantel… (Official, 2026-06-11)
  • indications: Ivermectin (To prevent canine heartworm disease by eliminating the tissue larval stages of Dirofilaria immitis for a month (30 days) after infection), pyrantel… (Official, 2026-06-10)
  • indications: Ivermectin (To prevent canine heartworm disease by eliminating the tissue larval stages of Dirofilaria immitis for a month (30 days) after infection), pyrantel… (Official, 2026-06-09)
Recent Revisions
  • side_effects updated 2026-04-22 10:14 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-04-22 10:14 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-04-22 10:14 by etl_backfill • Backfilled from existing medication fields
  • monitoring updated 2026-04-21 10:06 by curated_loader • Clinical monitoring context for feline diabetes management.
  • usage updated 2026-04-21 10:06 by curated_loader • Usage statement from FDA warning letter and approved-product context.
  • drug_profile_type updated 2026-04-21 10:06 by curated_loader • FDA source confirms Senvelgo as a branded approved product.
  • manufacturer_name updated 2026-04-21 10:06 by curated_loader • FDA warning letter identifies the approved sponsor/manufacturer.
  • brand_names updated 2026-04-21 10:06 by curated_loader • FDA warning letter references Senvelgo as the approved animal drug.
  • approval_reference updated 2026-04-21 10:06 by curated_loader • Official FDA application reference for Senvelgo.
  • monitoring updated 2026-04-20 10:08 by curated_loader • Clinical monitoring context for feline diabetes management.
  • usage updated 2026-04-20 10:08 by curated_loader • Usage statement from FDA warning letter and approved-product context.
  • drug_profile_type updated 2026-04-20 10:08 by curated_loader • FDA source confirms Senvelgo as a branded approved product.
  • manufacturer_name updated 2026-04-20 10:08 by curated_loader • FDA warning letter identifies the approved sponsor/manufacturer.
  • brand_names updated 2026-04-20 10:08 by curated_loader • FDA warning letter references Senvelgo as the approved animal drug.
  • approval_reference updated 2026-04-20 10:08 by curated_loader • Official FDA application reference for Senvelgo.
  • monitoring updated 2026-04-19 10:07 by curated_loader • Clinical monitoring context for feline diabetes management.
  • usage updated 2026-04-19 10:07 by curated_loader • Usage statement from FDA warning letter and approved-product context.
  • drug_profile_type updated 2026-04-19 10:07 by curated_loader • FDA source confirms Senvelgo as a branded approved product.
  • manufacturer_name updated 2026-04-19 10:07 by curated_loader • FDA warning letter identifies the approved sponsor/manufacturer.
  • brand_names updated 2026-04-19 10:07 by curated_loader • FDA warning letter references Senvelgo as the approved animal drug.

FDA Products & Applications (Animal Drugs @ FDA)

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

Product Sponsor Application Status Published
Tri-Heart Plus Chewable Tablets
RX
Ivermectin Pyrantel Pamoate
Tablet (Chewable) • Oral
Label highlights
Official documents
Diamond Animal Health, Inc. ANADA 200-338 Approved Feb 8, 2024
Heartgard® Plus
RX
Ivermectin Pyrantel Pamoate
Tablet (Chewable) • Oral
Label highlights
Official documents
Boehringer Ingelheim Animal Health USA, Inc. NADA 140-971 Approved Jun 1, 2016

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
Each chewable tablet contains either 68 micrograms of ivermectin and 57 milligrams of pyrantel (as pamoate salt), or 136 micrograms ivermectin and 114 milligrams pyrantel, or 272 micrograms and 227 milligrams, respectively.
Dogs
Indication
Ivermectin: to prevent canine heartworm diseases by eliminating the tissue larval stage of Dirofilaria immitis for a month (30 days) after infection. Pyrantel pamoate: for the treatment and control of adult Toxocara canis, Toxascaris leonina, Ancylostoma caninum, A braziliense, and Uncinaria stenocephala.
Dosage
A minimum of 6 micrograms of ivermectin and 5 milligrams of pyrantel (as pamoate salt) per kilogram (2.72 micrograms and 2.27 milligrams per pound) of body weight. up to 25 pounds: 68 micrograms ivermectin and 57 milligrams pyrantel pamoate 26 to 50 pounds: 136 micrograms ivermectin and 114 milligrams pyrantel pamoate 51 to 100 pounds: 272 micrograms ivermectin and 227 milligrams pyrantel pamoate
Limitations
Use monthly. Recommended for dogs 6 weeks of age or older. Federal law restricts this drug to use by or on the order of a veterinarian.

FDA page: Open in Animal Drugs @ FDA

Species: Dog
Composition / specifications
Each chewable tablet contains either 68 micrograms of ivermectin and 57 milligrams of pyrantel (as pamoate salt), or 136 micrograms ivermectin and 114 milligrams pyrantel, or 272 micrograms and 227 milligrams, respectively.
Dogs
Indication
To prevent canine heartworm diseases by eliminating the tissue stage of heartworm larvae (Dirofilaria immitis) for a month (30 days) after infection. For the treatment and control of ascarids (Toxocara canis, Toxascaris leonine), and hookworms (Ancylostoma caninum, A braziliense, and Uncinaria stenocephala).
Dosage
A minimum of 6 micrograms of ivermectin and 5 milligrams of pyrantel (as pamoate salt) per kilogram (2.72 micrograms and 2.27 milligrams per pound) of body weight. up to 25 pounds: 68 micrograms ivermectin and 57 milligrams pyrantel pamoate 26 to 50 pounds: 136 micrograms ivermectin and 114 milligrams pyrantel pamoate 51 to 100 pounds: 272 micrograms ivermectin and 227 milligrams pyrantel pamoate
Limitations
Use monthly. Recommended for dogs 6 weeks of age or older. Federal law restricts this drug to use by or on the order of a veterinarian. All dogs should be tested for existing heartworm infection before starting treatment with HEARTGARD Plus which is not effective against adult D. immitis. Infected dogs must be treated to remove adult heartworms and microfilariae before initiating a program with HEARTGARD Plus.

FDA page: Open in Animal Drugs @ FDA

Usage

To prevent canine heartworm diseases by eliminating the tissue stage of heartworm larvae ( Dirofilaria immitis ) for a month (30 days) after infection. For the treatment and control of ascarids ( Toxocara canis , Toxascaris leonine ), and hookworms ( Ancylostoma caninum , A braziliense , and Uncinaria stenocephala ). Ivermectin: to prevent canine heartworm diseases by eliminating the tissue larval stage of Dirofilaria immitis for a month (30 days) after infection. Pyrantel pamoate: for the treatment and control of adult Toxocara canis, Toxascaris leonina, Ancylostoma caninum, A braziliense, and Uncinaria stenocephala.

Source: FDA Animal Drugs @ FDA • Reference

Contraindications

Use monthly. Recommended for dogs 6 weeks of age or older. Federal law restricts this drug to use by or on the order of a veterinarian. All dogs should be tested for existing heartworm infection before starting treatment with HEARTGARD Plus which is not effective against adult D. immitis . Infected dogs must be treated to remove adult heartworms and microfilariae before initiating a program with HEARTGARD Plus. Use monthly. Recommended for dogs 6 weeks of age or older. Federal law restricts this drug to use by or on the order of a veterinarian.

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

Showing top 5 for Behavior.

Other
Trouble breathing (1) • Dog Elevated serum alkaline phosphatase (1) • Dog Elevated globulins (1) • Cat Elevated gamma-glutamyl transferase (1) • Dog Elevated creatinine (1) • Cat
Show more (22)
Elevated cholesterol (1) • Dog Elevated alanine aminotransferase (1) • Dog Dermal plaque (1) • Dog Dehydration (1) • Cat Decreased activity (1) • Cat 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 Autoimmune disorder NOS (1) • Dog Angioedema (1) • Dog Abnormal ultrasound finding (1) • Dog Abnormal radiograph finding (1) • Cat 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.

Dog, Dog (unknown), Male • Drug: MSK, Tablet, chewable, Unknown • Reactions: Sickness, Tiredness (lethargy), Loss of appetite, Staggering • Outcome: Recovered/Normal

  • Report ID: USA-USFDACVM-2025-US-075492
  • Serious AE: No
  • Treated For AE: No
  • Sex: Male
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Form: Tablet, chewable
Reactions Reported:
Sickness Tiredness (lethargy) Loss of appetite Staggering
Outcomes: Recovered/Normal

Dog, Beagle, Female, 4 year, 9.979 kilogram • Drug: MSK, Tablet, chewable, Oral, Dose: 1 tablet per animal • Reactions: Lack of efficacy (endoparasite) - hookworm • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-074016
  • Serious AE: No
  • Treated For AE: Yes
  • Sex: Female
  • Age: 4.00 Year
  • Weight: 9.979 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Tablet, chewable
  • Dose: 1 tablet per animal
Reactions Reported:
Lack of efficacy (endoparasite) - hookworm
Outcomes: Ongoing

Dog, Spaniel - King Charles Cavalier, Male, 5 year, 15.422 kilogram • Drug: MSK, Tablet, chewable, Oral, Dose: 1 tablet per animal, Frequency: 1 per month • Reactions: Lack of efficacy (bacteria) - Anaplasma • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-073999
  • Serious AE: No
  • Treated For AE: No
  • Sex: Male
  • Age: 5.00 Year
  • Weight: 15.422 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Tablet, chewable
  • Dose: 1 tablet per animal
  • Frequency: 1 per month
Reactions Reported:
Lack of efficacy (bacteria) - Anaplasma
Outcomes: Outcome Unknown

Dog, Collie - Border, Male, 10 year, 19.051 kilogram • Drug: MSK, Tablet, chewable, Oral, Dose: 1 tablet per animal • Reactions: Lack of efficacy (endoparasite) - heartworm • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-074655
  • Serious AE: No
  • Treated For AE: Yes
  • Sex: Male
  • Age: 10.00 Year
  • Weight: 19.051 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Tablet, chewable
  • Dose: 1 tablet per animal
Reactions Reported:
Lack of efficacy (endoparasite) - heartworm
Outcomes: Ongoing

Dog, Shepherd Dog - Belgian Malinois, Male, 2 year, 28.576 kilogram • Drug: MSK, Tablet, Oral, Dose: 1 tablet per animal, Frequency: 1 per month • Reactions: Lack of efficacy (bacteria) - Anaplasma • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-074299
  • Serious AE: No
  • Treated For AE: No
  • Sex: Male
  • Age: 2.00 Year
  • Weight: 28.576 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Tablet
  • Dose: 1 tablet per animal
  • Frequency: 1 per month
Reactions Reported:
Lack of efficacy (bacteria) - Anaplasma
Outcomes: Ongoing

Dog, Shepherd Dog - German, Female, 4 year, 38.555 kilogram • Drug: MSK, Tablet, chewable, Oral, Dose: 1 tablet per animal, Frequency: 1 per month • Reactions: Behavioral disorder (unspecified), Reluctant to move, Pacing, Crying, Nasal discharge • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-075100
  • Serious AE: No
  • Treated For AE: No
  • Sex: Female
  • Age: 4.00 Year
  • Weight: 38.555 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Tablet, chewable
  • Dose: 1 tablet per animal
  • Frequency: 1 per month
Reactions Reported:
Behavioral disorder (unspecified) Reluctant to move Pacing Crying Nasal discharge
Outcomes: Outcome Unknown

Dog, Havanese, Female, 8 year, 3.175 kilogram • Drug: MSK, Tablet, chewable, Oral, Dose: 1 tablet per animal • Reactions: Intestinal disorder NOS • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-075083
  • Serious AE: No
  • Treated For AE: Yes
  • Sex: Female
  • Age: 8.00 Year
  • Weight: 3.175 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Tablet, chewable
  • Dose: 1 tablet per animal
Reactions Reported:
Intestinal disorder NOS
Outcomes: Outcome Unknown

Dog, Sheepdog (unspecified), Female, 8 year, 32.205 kilogram • Drug: MSK, Tablet, Oral, Dose: 272 Microgram per animal, Frequency: 1 per month • Reactions: Vomiting • Outcome: Recovered/Normal

  • Report ID: USA-USFDACVM-2025-US-073495
  • Serious AE: No
  • Treated For AE: No
  • Sex: Female
  • Age: 8.00 Year
  • Weight: 32.205 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Tablet
  • Dose: 272 Microgram per animal
  • Frequency: 1 per month
Reactions Reported:
Vomiting
Outcomes: Recovered/Normal

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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