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Roxee Meds Catalog

Pyrantel Pamoate/Praziquantel

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

Both Catalog complete FDA data linked Non-Rx Tablet Multiple FDA labelers Official label facts Owner quick guide first

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Data freshness

Storefront facts
Catalog refreshed
Apr 22, 2026, 10:07 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
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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 22, 2026, 10:07 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.
  • Animal Drug Product Listing Directory (NDC): Source FDA | Refreshed May 5, 2026, 10:00 AM UTC
    Package/product NDCs from FDA’s electronic listing directory (XLS).

Evidence

Reviewed / Updated / Sources

Reviewed by: Not available

Last reviewed: April 22, 2026

Updated: April 22, 2026, 10:06 AM UTC

Sources:
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Pyrantel Pamoate/Praziquantel

Pyrantel Pamoate/Praziquantel

Drug type: Generic ingredient • Branded profile FDA branded products available

Both Tablet Non-Rx 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.

Pyrantel Pamoate/Praziquantel

For the treatment and control of roundworms ( Toxocara canis and Toxascaris leonine ), hookworms ( Ancylostoma caninum , Ancylostoma braziliense , and Uncinaria stenocephala ), and tapeworms ( Dipylidium caninum and Taenia pisiformis ) in dogs and puppies. For removal of the common parasites of cats and kittens including tapeworms ( Dipylidium caninum, Taenia taeniaeformis ), hookworms ( Ancylostoma tubaeforme ), and large roundworms ( Toxocara cati ). Species commonly shown: Both, Cat And Kitten, Excluding Under 2 Months Of Age Or Under 2 Pounds Weight, Dogs And Puppies.

Generic name
Pyrantel Pamoate/Praziquantel
Brand names
Drontal™ Tablets, Virbantel® Worm X Plus®, Drontal, WORMXPLUS
Manufacturer
Multiple FDA labelers
Species
Both, Cat And Kitten, Excluding Under 2 Months Of Age Or Under 2 Pounds Weight, Dogs And Puppies
Dosage forms
Tablet, Tablet (Chewable)
Prescription
Non-prescription
Completeness
100%
Validation
Complete
Brand names
Drontal™ Tablets Virbantel® Worm X Plus® Drontal WORMXPLUS Triple Wormer 7 Way De-Wormer Virbantel
Dosage forms
Tablet Tablet (Chewable)

Indications / Uses

For the treatment and control of roundworms ( Toxocara canis and Toxascaris leonine ), hookworms ( Ancylostoma caninum , Ancylostoma braziliense , and Uncinaria stenocephala ), and tapeworms ( Dipylidium caninum and Taenia pisiformis ) in dogs and puppies. For removal of the common parasites of cats and kittens including tapeworms ( Dipylidium caninum, Taenia taeniaeformis ), hookworms ( Ancylostoma tubaeforme ), and large roundworms ( Toxocara cati ).

Warnings / Contraindications

Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.Do not de-worm a dog or puppy that is sick. Consult a veterinarian for diagnosis of the illness. VIRBANTEL® Flavored Chewables are safe for use in puppies 12 weeks or older and adult dogs. Safety in breeding dogs and pregnant bitches has not been tested. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. Do not de-worm a dog or puppy that is sick. Consult a veterinarian for diagnosis of the illness. Worm X Plus® Flavored Chewables are safe for use in puppies 12 weeks or older and adult dogs. Safety in breeding dogs and pregnant bitches has not been tested. May be given directly by mouth or in a small amount of food. Do not withhold food prior to or after treatment. If reinfection occurs, treatment may be repeated. Consult your veterinarian before giving to sick or pregnant animals. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. Not for use in kittens less than 2 months of age or weighing less than 2.0 pounds.

  • Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.Do not de-worm a dog or puppy that is sick. Consult a veterinarian for diagnosis of the illness. VIRBANTEL® Flavored Chewables are safe for use in puppies 12 weeks or older and adult dogs. Safety in breeding dogs and pregnant bitches has not been tested. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. Do not de-worm a dog or puppy that is sick. Consult a veterinarian for diagnosis of the illness. Worm X Plus® Flavored Chewables are safe for use in puppies 12 weeks or older and adult dogs. Safety in breeding dogs and pregnant bitches has not been tested. May be given directly by mouth or in a small amount of food. Do not withhold food prior to or after treatment. If reinfection occurs, treatment may be repeated. Consult your veterinarian before giving to sick or pregnant animals. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. Not for use in kittens less than 2 months of age or weighing less than 2.0 pounds.

Side Effects

Top reported reactions (openFDA): Vomiting, Lethargy (see also Central nervous system depression in 'Neurological'), Diarrhoea, Overdose, Drug administration error, Emesis (multiple).

FAQ

Both, Cat And Kitten, Excluding Under 2 Months Of Age Or Under 2 Pounds Weight, Dogs And Puppies

No. Roxee does not currently show this as prescription-only.

Tablet, Tablet (Chewable)

Source Transparency

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Pet Owner Quick Guide

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Used for:

For the treatment and control of roundworms ( Toxocara canis and Toxascaris leonine ), hookworms ( Ancylostoma caninum , Ancylostoma braziliense , and Uncinaria stenocephala ), and tapeworms ( Dipylidium caninum and Taen...

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:

  • Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.Do not de-worm a dog or puppy that is sick
  • Consult a veterinarian for diagnosis of the illness
  • VIRBANTEL® Flavored Chewables are safe for use in puppies 12 weeks or older and adult dogs
  • Safety in breeding dogs and pregnant bitches has not been tested
  • Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism
  • Do not de-worm a dog or puppy that is sick
  • Worm X Plus® Flavored Chewables are safe for use in puppies 12 weeks or older and adult dogs
  • May be given directly by mouth or in a small amount of food
  • Do not withhold food prior to or after treatment
  • If reinfection occurs, treatment may be repeated
  • Consult your veterinarian before giving to sick or pregnant animals
  • Not for use in kittens less than 2 months of age or weighing less than 2.0 pounds
  • Vomiting (1 reports)
  • Underdose (1 reports)
  • very low energy (1 reports)

When to call the vet:

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

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:

  • Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.Do not de-worm a dog or puppy that is sick
  • Consult a veterinarian for diagnosis of the illness
  • VIRBANTEL® Flavored Chewables are safe for use in puppies 12 weeks or older and adult dogs
  • Safety in breeding dogs and pregnant bitches has not been tested
  • Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism

Most reported reactions:

  • Vomiting (1 reports)
  • Underdose (1 reports)
  • Tiredness (lethargy) (1 reports)

Emergency warning signs:

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

Quick Facts

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

Species: Both
Manufacturer: Multiple FDA labelers
Form: Tablet, Tablet (Chewable)
Identifiers:
NADA: 141008 NADA: 141261 NDC Package: 21091-641-01 NDC Package: 21091-641-02 NDC Package: 21091-641-03 NDC Package: 21091-642-01 NDC Package: 21091-642-02 NDC Package: 21091-642-03 NDC Package: 21091-703-02 NDC Package: 21091-703-12 NDC Package: 30798-185-61 NDC Package: 30798-185-71 NDC Package: 30798-186-61 NDC Package: 30798-186-71 NDC Package: 51311-504-02 NDC Package: 51311-505-04 NDC Package: 51311-506-06 NDC Package: 51311-507-08 NDC Package: 51311-738-10 NDC Package: 51311-741-10
Source metadata:

Warnings / Contraindications

Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.Do not de-worm a dog or puppy that is sick. Consult a veterinarian for diagnosis of the illness. VIRBANTEL® Flavored Chewables are safe for use in puppies 12 weeks or older and adult dogs. Safety in breeding dogs and pregnant bitches has not been tested. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. Do not de-worm a dog or puppy that is sick. Consult a veterinarian for diagnosis of the illness. Worm X Plus® Flavored Chewables are safe for use in puppies 12 weeks or older and adult dogs. Safety in breeding dogs and pregnant bitches has not been tested. May be given directly by mouth or in a small amount of food. Do not withhold food prior to or after treatment. If reinfection occurs, treatment may be repeated. Consult your veterinarian before giving to sick or pregnant animals. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. Not for use in kittens less than 2 months of age or weighing less than 2.0 pounds.

  • High: Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.Do not de-worm a dog or puppy that is sick. Consult a veterinarian for diagnosis of the illness. VIRBANTEL® Flavored Chewables are safe for use in puppies 12 weeks or older and adult dogs. Safety in breeding dogs and pregnant bitches has not been tested. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. Do not de-worm a dog or puppy that is sick. Consult a veterinarian for diagnosis of the illness. Worm X Plus® Flavored Chewables are safe for use in puppies 12 weeks or older and adult dogs. Safety in breeding dogs and pregnant bitches has not been tested. May be given directly by mouth or in a small amount of food. Do not withhold food prior to or after treatment. If reinfection occurs, treatment may be repeated. Consult your veterinarian before giving to sick or pregnant animals. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. Not for use in kittens less than 2 months of age or weighing less than 2.0 pounds.
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
18
Reported cases
12
Serious reports
0
Species represented
2
Grouped by Body System
Digestive (2) · Vomiting, Diarrhea Neurologic (2) · Tiredness (lethargy), Lethargy (see also Central nervous system depression in 'Neurological') Effectiveness (4) · Lack of efficacy (endoparasite) - Toxocara/Toxascaris, Lack of efficacy (endoparasite) - tapeworm, Lack of efficacy (endoparasite) - roundworm NOS Other (10) · Underdose, Drug dose administration interval too short, Cough
Most Reported Reactions
Reaction Body system Cases Species Serious cases
Digestive 1 Cat, Dog 0
Other 1 Dog 0
Neurologic 1 Cat 0
Effectiveness 1 Dog 0
Effectiveness 1 Dog 0
Effectiveness 1 Dog 0
Effectiveness 1 Dog 0
Other 1 Dog 0

Species coverage: Dog (14) Cat (4)

View detailed reaction table
Reaction Body system Species Seriousness Frequency Reports
Digestive Cat Non-serious - 1
Other Dog Non-serious - 1
Neurologic Cat Non-serious - 1
Effectiveness Dog Non-serious - 1
Effectiveness Dog Non-serious - 1
Effectiveness Dog Non-serious - 1
Effectiveness Dog Non-serious - 1
Other Dog Non-serious - 1
Digestive Dog Non-serious - 1
Other Dog Non-serious - 1
Other Dog Non-serious - 1
Other Cat Non-serious - 1
Other Dog Unknown - -
Other Dog Unknown - -
Other Dog Unknown - -
Neurologic Cat Unknown - -
Other Dog Unknown - -
Other Dog Unknown - -
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

11

FOI

2

Virbantel®

SPL · SPL

FDA Structured Product Label

Virbantel® Worm X 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
Virbac AH, Inc.
NADA
141-261
Status
OTC
Form
Tablet (Chewable)
Route
Oral
Species
Dogs And Puppies
Composition / specifications
Each chewable tablet contains: 30 mg praziquantel and 30 mg pyrantel pamoate (For Small Dogs and Puppies) or 114 mg praziquantel and 114 mg pyrantel pamoate (For Medium and Large Dogs).

Dogs (Puppies and Small Dogs 6.0-25 Lbs)

Indication
For the treatment and control of roundworms (Toxocara canis and Toxascaris leonine), hookworms (Ancylostoma caninum, Ancylostoma braziliense, and Uncinaria stenocephala), and tapeworms (Dipylidium caninum and Taenia pisiformis) in dogs and puppies.
Dosage
Administer a minimum dose of 5 milligrams praziquantel and 5 milligrams pyrantel pamoate per kilogram body weight (2.27 milligrams praziquantel and 2.27 milligrams pyrantel pamoate per pound body weight) according to the dosing tables on labeling.
Limitations

Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.Do not de-worm a dog or puppy that is sick. Consult a veterinarian for diagnosis of the illness. VIRBANTEL® Flavored Chewables are safe for use in puppies 12 weeks or older and adult dogs. Safety in breeding dogs and pregnant bitches has not been tested.

Dogs (Medium and Large Dogs- Greater than 25 Lbs)

Indication
For the treatment and control of roundworms (Toxocara canis and Toxascaris leonine), hookworms (Ancylostoma caninum, Ancylostoma braziliense, and Uncinaria stenocephala), and tapeworms (Dipylidium caninum and Taenia pisiformis) in dogs and puppies.
Dosage
Administer a minimum dose of 5 milligrams praziquantel and 5 milligrams pyrantel pamoate per kilogram body weight (2.27 milligrams praziquantel and 2.27 milligrams pyrantel pamoate per pound body weight) according to the dosing tables on labeling.
Limitations

Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.Do not de-worm a dog or puppy that is sick. Consult a veterinarian for diagnosis of the illness. VIRBANTEL® Flavored Chewables are safe for use in puppies 12 weeks or older and adult dogs. Safety in breeding dogs and pregnant bitches has not been tested.

Worm X Plus®

SPL · SPL

FDA Structured Product Label

Virbantel® Worm X 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
Virbac AH, Inc.
NADA
141-261
Status
OTC
Form
Tablet (Chewable)
Route
Oral
Species
Dogs And Puppies
Composition / specifications
Each chewable tablet contains: 30 mg praziquantel and 30 mg pyrantel pamoate (For Small Dogs and Puppies) or 114 mg praziquantel and 114 mg pyrantel pamoate (For Medium and Large Dogs).

Dogs (Puppies and Small Dogs 6.0-25 Lbs)

Indication
For the treatment and control of roundworms (Toxocara canis and Toxascaris leonine), hookworms (Ancylostoma caninum, Ancylostoma braziliense, and Uncinaria stenocephala), and tapeworms (Dipylidium caninum and Taenia pisiformis) in dogs and puppies.
Dosage
Administer a minimum dose of 5 milligrams praziquantel and 5 milligrams pyrantel pamoate per kilogram body weight (2.27 milligrams praziquantel and 2.27 milligrams pyrantel pamoate per pound body weight) according to the dosing tables on labeling.
Limitations

Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.Do not de-worm a dog or puppy that is sick. Consult a veterinarian for diagnosis of the illness. VIRBANTEL® Flavored Chewables are safe for use in puppies 12 weeks or older and adult dogs. Safety in breeding dogs and pregnant bitches has not been tested.

Dogs (Medium and Large Dogs- Greater than 25 Lbs)

Indication
For the treatment and control of roundworms (Toxocara canis and Toxascaris leonine), hookworms (Ancylostoma caninum, Ancylostoma braziliense, and Uncinaria stenocephala), and tapeworms (Dipylidium caninum and Taenia pisiformis) in dogs and puppies.
Dosage
Administer a minimum dose of 5 milligrams praziquantel and 5 milligrams pyrantel pamoate per kilogram body weight (2.27 milligrams praziquantel and 2.27 milligrams pyrantel pamoate per pound body weight) according to the dosing tables on labeling.
Limitations

Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.Do not de-worm a dog or puppy that is sick. Consult a veterinarian for diagnosis of the illness. VIRBANTEL® Flavored Chewables are safe for use in puppies 12 weeks or older and adult dogs. Safety in breeding dogs and pregnant bitches has not been tested.

Drontal™ Tablets

SPL · SPL

FDA Structured Product Label

Drontal™ 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
Elanco US Inc.
NADA
141-008
Status
OTC
Form
Tablet
Route
Oral
Species
Cat And Kitten, Excluding Under 2 Months Of Age Or Under 2 Pounds Weight
Composition / specifications
Each tablet contains 18.2 mg praziquantel and 72.6 mg pyrantel base as pyrantel pamoate.

Cats and Kittens (Greater Than 2 Months of Age Or At Least 2 Lbs)

Indication
For removal of the common parasites of cats and kittens including tapeworms (Dipylidium caninum, Taenia taeniaeformis), hookworms (Ancylostoma tubaeforme), and large roundworms (Toxocara cati).
Dosage
Administer a minimum dose of 2.27 mg praziquantel and 9.2 pyrantel pamoate per pound of bodyweight according to the dosing tables on labeling.
Limitations

May be given directly by mouth or in a small amount of food. Do not withhold food prior to or after treatment. If reinfection occurs, treatment may be repeated. Consult your veterinarian before giving to sick or pregnant animals. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. Not for use in kittens less than 2 months of age or weighing less than 2.0 pounds.

7 Way De-Wormer SPL

SPL · Structured Product Label

FDA Structured Product Label XML for 7 Way De-Wormer. Use the source link for the full official labeling record.

Virbantel SPL

SPL · Structured Product Label

FDA Structured Product Label XML for Virbantel. Use the source link for the full official labeling record.

7 Way De-Wormer SPL

SPL · Structured Product Label

FDA Structured Product Label XML for 7 Way De-Wormer. Use the source link for the full official labeling record.

Triple Wormer SPL

SPL · Structured Product Label

FDA Structured Product Label XML for Triple Wormer. Use the source link for the full official labeling record.

Virbantel SPL

SPL · Structured Product Label

FDA Structured Product Label XML for Virbantel. Use the source link for the full official labeling record.

WORMXPLUS SPL

SPL · Structured Product Label

FDA Structured Product Label XML for WORMXPLUS. Use the source link for the full official labeling record.

Triple Wormer SPL

SPL · Structured Product Label

FDA Structured Product Label XML for Triple Wormer. Use the source link for the full official labeling record.

Drontal SPL

SPL · Structured Product Label

FDA Structured Product Label XML for Drontal. Use the source link for the full official labeling record.

UCM050062.pdf

FOI · FOI

UCM487815.pdf

FOI · FOI

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 22, 2026, 10:07 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.
  • Animal Drug Product Listing Directory (NDC): Source FDA | Refreshed May 5, 2026, 10:00 AM UTC
    Package/product NDCs from FDA’s electronic listing directory (XLS).
Official (FDA)
Identity: Generic ingredient • FDA branded products available
Official FDA brands: 7 Way De-Wormer Drontal Triple Wormer Virbantel WORMXPLUS
Manufacturer mapping: Multiple FDA labelers
Catalog species: Both FDA-labeled species: Cat And Kitten, Dogs And Puppies
Rx/OTC: OTC
Form/route: Tablet, Tablet (Chewable) Oral
Applications: NADA 141-261 • NADA 141-008
NDC: Packages 21091-641-01 21091-641-02 21091-641-03 21091-642-01 21091-642-02 21091-642-03 Products 21091 30798 51311 58198
Documents: 2 (FOI: 2) • SPL: 3 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.

Diagnosis Codes

Diagnosis-code mappings are not available for this medication yet.

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
  • Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.Do not de-worm a dog or puppy that is sick. Consult a veterinarian for diagnosis of the illness. VIRBANTEL® Flavored Chewables are safe for use in puppies 12 weeks or older and adult dogs. Safety in breeding dogs and pregnant bitches has not been tested. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. Do not de-worm a dog or puppy that is sick. Consult a veterinarian for diagnosis of the illness. Worm X Plus® Flavored Chewables are safe for use in puppies 12 weeks or older and adult dogs. Safety in breeding dogs and pregnant bitches has not been tested. May be given directly by mouth or in a small amount of food. Do not withhold food prior to or after treatment. If reinfection occurs, treatment may be repeated. Consult your veterinarian before giving to sick or pregnant animals. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. Not for use in kittens less than 2 months of age or weighing less than 2.0 pounds. (Contraindication, High)
Top reaction signals
Vomiting (1) Underdose (1) Tiredness (lethargy) (1) Lack of efficacy (endoparasite) - Toxocara/Toxascaris (1) Lack of efficacy (endoparasite) - tapeworm (1) Lack of efficacy (endoparasite) - roundworm NOS (1) Lack of efficacy (endoparasite) - hookworm (1) Drug dose administration interval too short (1)

Identifiers & Packages

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

Identifiers
NADA: 141008 NADA: 141261 NDC Package: 21091-641-01 NDC Package: 21091-641-02 NDC Package: 21091-641-03 NDC Package: 21091-642-01 NDC Package: 21091-642-02 NDC Package: 21091-642-03 NDC Package: 21091-703-02 NDC Package: 21091-703-12 NDC Package: 30798-185-61 NDC Package: 30798-185-71 NDC Package: 30798-186-61 NDC Package: 30798-186-71 NDC Package: 51311-504-02 NDC Package: 51311-505-04 NDC Package: 51311-506-06 NDC Package: 51311-507-08 NDC Package: 51311-738-10 NDC Package: 51311-741-10 NDC Package: 58198-0034-1 NDC Product: 21091 NDC Product: 30798 NDC Product: 51311
Package NDC Product NDC Form / Route Status
21091-641-01 21091 -
21091-641-02 21091 -
21091-641-03 21091 -
21091-642-01 21091 -
21091-642-02 21091 -
21091-642-03 21091 -
21091-703-02 21091 -
21091-703-12 21091 -
30798-185-61 30798 -
30798-185-71 30798 -
30798-186-61 30798 -
30798-186-71 30798 -
51311-504-02 51311 -
51311-505-04 51311 -
51311-506-06 51311 -
51311-507-08 51311 -
51311-738-10 51311 -
51311-741-10 51311 -
58198-0034-1 58198 -

Enriched Documents

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

  • 7 Way De-Wormer SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Virbantel SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • 7 Way De-Wormer SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Triple Wormer SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Virbantel SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • WORMXPLUS SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Triple Wormer SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Drontal SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • UCM050062.pdf • FOI summary • Official • July 13, 2023
    FDA FOI summary for application 141261
  • UCM487815.pdf • FOI summary • Official • May 10, 2022
    FDA FOI summary for application 141008

Data Sources & Change Log

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

Official 31 Clinical 3 Manufacturer 0 Marketing 0
Current Field Facts
  • side_effects: Top reported reactions (openFDA): Vomiting, Lethargy (see also Central nervous system depression in 'Neurological'), Diarrhoea, Overdose, Drug administration e… (Clinical, 2026-04-22)
  • side_effects: Top reported reactions (openFDA): Vomiting, Lethargy (see also Central nervous system depression in 'Neurological'), Diarrhoea, Overdose, Drug administration e… (Clinical, 2026-04-15)
  • side_effects: Top reported reactions (openFDA): Vomiting, Lethargy (see also Central nervous system depression in 'Neurological'), Diarrhoea, Overdose, Drug administration e… (Clinical, 2026-04-11)
  • contraindications: Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.Do not de-worm a dog or puppy that is sick. Consult a veterinar… (Official, 2026-04-22)
  • indications: For the treatment and control of roundworms (Toxocara canis, Toxascaris leonina); hookworms (Ancylostoma caninum, Ancylostoma braziliense, Uncinaria stenocepha… (Official, 2026-05-05)
  • indications: For the treatment and control of roundworms (Toxocara canis, Toxascaris leonina); hookworms (Ancylostoma caninum, Ancylostoma braziliense, Uncinaria stenocepha… (Official, 2026-05-03)
  • indications: For the treatment and control of roundworms (Toxocara canis, Toxascaris leonina); hookworms (Ancylostoma caninum, Ancylostoma braziliense, Uncinaria stenocepha… (Official, 2026-05-02)
  • indications: For the treatment and control of roundworms (Toxocara canis, Toxascaris leonina); hookworms (Ancylostoma caninum, Ancylostoma braziliense, Uncinaria stenocepha… (Official, 2026-04-29)
  • indications: For the treatment and control of roundworms (Toxocara canis, Toxascaris leonina); hookworms (Ancylostoma caninum, Ancylostoma braziliense, Uncinaria stenocepha… (Official, 2026-04-28)
  • indications: For the treatment and control of roundworms (Toxocara canis, Toxascaris leonina); hookworms (Ancylostoma caninum, Ancylostoma braziliense, Uncinaria stenocepha… (Official, 2026-04-27)
  • indications: For the treatment and control of roundworms (Toxocara canis, Toxascaris leonina); hookworms (Ancylostoma caninum, Ancylostoma braziliense, Uncinaria stenocepha… (Official, 2026-04-26)
  • indications: For the treatment and control of roundworms (Toxocara canis, Toxascaris leonina); hookworms (Ancylostoma caninum, Ancylostoma braziliense, Uncinaria stenocepha… (Official, 2026-04-25)
  • indications: For the treatment and control of roundworms (Toxocara canis, Toxascaris leonina); hookworms (Ancylostoma caninum, Ancylostoma braziliense, Uncinaria stenocepha… (Official, 2026-04-22)
  • manufacturer_name: Multiple FDA labelers (Official, 2026-05-05)
  • manufacturer_name: Multiple FDA labelers (Official, 2026-05-03)
  • manufacturer_name: Multiple FDA labelers (Official, 2026-05-02)
  • manufacturer_name: Multiple FDA labelers (Official, 2026-04-29)
  • manufacturer_name: Multiple FDA labelers (Official, 2026-04-28)
  • manufacturer_name: Multiple FDA labelers (Official, 2026-04-27)
  • manufacturer_name: Multiple FDA labelers (Official, 2026-04-26)
Recent Revisions
  • side_effects updated 2026-04-22 10:07 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-04-22 10:07 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-04-22 10:07 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
Virbantel® Worm X Plus®
OTC
Praziquantel Pyrantel Pamoate
Tablet (Chewable) Oral
Virbac AH, Inc. NADA 141-261 Approved Jul 13, 2023
Drontal™ Tablets
OTC
Praziquantel Pyrantel Pamoate
Tablet Oral
Elanco US Inc. NADA 141-008 Approved May 10, 2022

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: Dogs And Puppies
Composition / specifications
Each chewable tablet contains: 30 mg praziquantel and 30 mg pyrantel pamoate (For Small Dogs and Puppies) or 114 mg praziquantel and 114 mg pyrantel pamoate (For Medium and Large Dogs).
Dogs (Puppies and Small Dogs 6.0-25 Lbs)
Indication
For the treatment and control of roundworms (Toxocara canis and Toxascaris leonine), hookworms (Ancylostoma caninum, Ancylostoma braziliense, and Uncinaria stenocephala), and tapeworms (Dipylidium caninum and Taenia pisiformis) in dogs and puppies.
Dosage
Administer a minimum dose of 5 milligrams praziquantel and 5 milligrams pyrantel pamoate per kilogram body weight (2.27 milligrams praziquantel and 2.27 milligrams pyrantel pamoate per pound body weight) according to the dosing tables on labeling.
Limitations

Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.Do not de-worm a dog or puppy that is sick. Consult a veterinarian for diagnosis of the illness. VIRBANTEL® Flavored Chewables are safe for use in puppies 12 weeks or older and adult dogs. Safety in breeding dogs and pregnant bitches has not been tested.

Dogs (Medium and Large Dogs- Greater than 25 Lbs)
Indication
For the treatment and control of roundworms (Toxocara canis and Toxascaris leonine), hookworms (Ancylostoma caninum, Ancylostoma braziliense, and Uncinaria stenocephala), and tapeworms (Dipylidium caninum and Taenia pisiformis) in dogs and puppies.
Dosage
Administer a minimum dose of 5 milligrams praziquantel and 5 milligrams pyrantel pamoate per kilogram body weight (2.27 milligrams praziquantel and 2.27 milligrams pyrantel pamoate per pound body weight) according to the dosing tables on labeling.
Limitations

Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.Do not de-worm a dog or puppy that is sick. Consult a veterinarian for diagnosis of the illness. VIRBANTEL® Flavored Chewables are safe for use in puppies 12 weeks or older and adult dogs. Safety in breeding dogs and pregnant bitches has not been tested.

FDA page: Open in Animal Drugs @ FDA

Species: Cat And Kitten, Excluding Under 2 Months Of Age Or Under 2 Pounds Weight
Composition / specifications
Each tablet contains 18.2 mg praziquantel and 72.6 mg pyrantel base as pyrantel pamoate.
Cats and Kittens (Greater Than 2 Months of Age Or At Least 2 Lbs)
Indication
For removal of the common parasites of cats and kittens including tapeworms (Dipylidium caninum, Taenia taeniaeformis), hookworms (Ancylostoma tubaeforme), and large roundworms (Toxocara cati).
Dosage
Administer a minimum dose of 2.27 mg praziquantel and 9.2 pyrantel pamoate per pound of bodyweight according to the dosing tables on labeling.
Limitations

May be given directly by mouth or in a small amount of food. Do not withhold food prior to or after treatment. If reinfection occurs, treatment may be repeated. Consult your veterinarian before giving to sick or pregnant animals. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. Not for use in kittens less than 2 months of age or weighing less than 2.0 pounds.

FDA page: Open in Animal Drugs @ FDA

Usage

For the treatment and control of roundworms ( Toxocara canis and Toxascaris leonine ), hookworms ( Ancylostoma caninum , Ancylostoma braziliense , and Uncinaria stenocephala ), and tapeworms ( Dipylidium caninum and Taenia pisiformis ) in dogs and puppies. For removal of the common parasites of cats and kittens including tapeworms ( Dipylidium caninum, Taenia taeniaeformis ), hookworms ( Ancylostoma tubaeforme ), and large roundworms ( Toxocara cati ).

Source: FDA Animal Drugs @ FDA • Reference

Contraindications

Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.Do not de-worm a dog or puppy that is sick. Consult a veterinarian for diagnosis of the illness. VIRBANTEL® Flavored Chewables are safe for use in puppies 12 weeks or older and adult dogs. Safety in breeding dogs and pregnant bitches has not been tested. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. Do not de-worm a dog or puppy that is sick. Consult a veterinarian for diagnosis of the illness. Worm X Plus® Flavored Chewables are safe for use in puppies 12 weeks or older and adult dogs. Safety in breeding dogs and pregnant bitches has not been tested. May be given directly by mouth or in a small amount of food. Do not withhold food prior to or after treatment. If reinfection occurs, treatment may be repeated. Consult your veterinarian before giving to sick or pregnant animals. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. Not for use in kittens less than 2 months of age or weighing less than 2.0 pounds.

Top Reported Reactions (openFDA)

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

Digestive
Vomiting (1) • Cat, Dog Diarrhea (1) • Dog

Showing top 5 for Digestive.

Neurologic
Tiredness (1) • Cat Tiredness (lethargy) • Cat

Showing top 5 for Neurologic.

Effectiveness
Lack of efficacy (endoparasite) - Toxocara/Toxascaris (1) • Dog Lack of efficacy (endoparasite) - tapeworm (1) • Dog Lack of efficacy (endoparasite) - roundworm NOS (1) • Dog Lack of efficacy (endoparasite) - hookworm (1) • Dog

Showing top 5 for Effectiveness.

Other
Underdose (1) • Dog Drug dose administration interval too short (1) • Dog Cough (1) • Dog Blood in faeces NOS (1) • Dog Accidental exposure (1) • Cat
Show more (4)
Shaking • Dog Overdose • Dog Not eating • Dog Drug administration error • Dog

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.

Share Your Thoughts

Let others know your experience or advice regarding this medication.

This medication has not been reviewed by a veterinarian yet.