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Roxee Meds Catalog

Ivermectin/Pyrantel Pamoate Chewable 136Mcg/326Mg

Medication catalog facts with explicit FDA-approval, off-label, source-limited, and safety context.

Both Catalog complete FDA data linked Rx required Tablet (Chewable) Multiple FDA labelers Official label facts Owner quick guide first
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Data freshness

Storefront facts
Catalog refreshed
Apr 25, 2026, 10:00 a.m.

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

FDA applications
FDA application data refreshed
May 5, 2026, 10:00 a.m.

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

Safety reports
Safety data refreshed
May 5, 2026, 10:01 a.m.

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

Source timing details
Source timing details
  • Storefront facts: Source Roxee | Refreshed Apr 25, 2026, 10:00 AM UTC
    The storefront fact projection used for browse cards and quick facts.
  • Animal Drugs @ FDA: Source FDA | Refreshed May 5, 2026, 10:00 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 May 5, 2026, 10:04 AM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed May 5, 2026, 10:04 AM UTC

Evidence

Reviewed / Updated / Sources

Reviewed by: Not available

Last reviewed: April 22, 2026

Updated: April 22, 2026, 10:15 AM UTC

Sources:
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Ivermectin/Pyrantel Pamoate Chewable 136Mcg/326Mg

Ivermectin/Pyrantel Pamoate Chewable 136Mcg/326Mg

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

Both Tablet (Chewable) Rx required 100% storefront ready

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 136Mcg/326Mg

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, No Use Class Stated Or Implied.

Generic name
Ivermectin/Pyrantel Pamoate Chewable 136Mcg/326Mg
Brand names
Heartgard® Plus, Tri-Heart Plus Chewable Tablets
Manufacturer
Multiple FDA labelers
Species
Both, Dog, Excluding Under 6 Weeks Age, Dog, No Use Class Stated Or Implied
Dosage forms
Tablet (Chewable)
Prescription
Prescription required
Completeness
100%
Validation
Complete
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): Lack of efficacy (endoparasite) - heartworm, Vomiting, Diarrhoea, Lethargy (see also Central nervous system depression in 'Neurological'), Lack of efficacy (endoparasite) - hookworm, Anorexia.

FAQ

Both, Dog, Excluding Under 6 Weeks Age, Dog, No Use Class Stated Or Implied

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 globulins (1 reports)
  • Elevated gamma-glutamyl transferase (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?
Major cautions & emergency warning signs

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 globulins (1 reports)
  • Elevated gamma-glutamyl transferase (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

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.

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

Tracked signals
32
Reported cases
32
Serious reports
25
Species represented
2
Grouped by Body System
Digestive (3) · Loss of appetite, Drooling, Diarrhea Skin & allergy (1) · Alopecia NOS Behavior (2) · Behavioral disorder (unspecified), Attention-seeking behaviour Other (26) · Trouble breathing (dyspnea), Elevated globulins, Elevated gamma-glutamyl transferase
Most Reported Reactions
Reaction Body system Cases Species Serious cases
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
Other 1 Cat 1

Species coverage: Dog (22) Cat (10)

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

Documents

Owner handouts and official technical documents open on-page first, with the original source still one click away.

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, No Use Class Stated Or Implied
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, Excluding Under 6 Weeks Age
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
  • Storefront facts: Source Roxee | Refreshed Apr 25, 2026, 10:00 AM UTC
    The storefront fact projection used for browse cards and quick facts.
  • Animal Drugs @ FDA: Source FDA | Refreshed May 5, 2026, 10:00 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 May 5, 2026, 10:04 AM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed May 5, 2026, 10:04 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 globulins (1) Elevated gamma-glutamyl transferase (1) Elevated creatinine (1) Elevated cholesterol (1) Elevated alanine aminotransferase (1) Dermal plaque (1) Dehydration (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 32 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): Lack of efficacy (endoparasite) - heartworm, Vomiting, Diarrhoea, Lethargy (see also Central nervous system depression in 'Ne… (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, 2026-05-05)
  • 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, 2026-05-03)
  • 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, 2026-05-02)
  • 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, 2026-04-29)
  • 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, 2026-04-28)
  • 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, 2026-04-27)
  • 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, 2026-04-26)
  • 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, 2026-04-25)
  • 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, 2026-04-22)
  • manufacturer_name: Multiple FDA labelers (Official, 2026-04-22)
  • prescription_required: Rx required (Official, 2026-04-22)
Recent Revisions
  • side_effects updated 2026-04-22 10:15 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-04-22 10:15 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-04-22 10:15 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, No Use Class Stated Or Implied
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, Excluding Under 6 Weeks Age
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) • Cat

Showing top 5 for Digestive.

Skin & allergy
Alopecia NOS (1) • Dog

Showing top 5 for Skin & allergy.

Behavior
Behavioral disorder (1) • Dog Attention-seeking behaviour (1) • Dog

Showing top 5 for Behavior.

Other
Trouble breathing (1) • Dog Elevated globulins (1) • Cat Elevated gamma-glutamyl transferase (1) • Dog Elevated creatinine (1) • Cat Elevated cholesterol (1) • Dog
Show more (21)
Elevated alanine aminotransferase (1) • Dog Drug dose omission (1) • Dog Dermal plaque (1) • Dog Dehydration (1) • Cat Decreased activity (1) • Cat Death (1) • Dog 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.

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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