Worm Protector 2X

Manufacturer
Huvepharma, Inc | Happy Jack Inc
Effective date
2025-11-20
Label type
OTC ANIMAL DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 02:45:12

Label at a glance#

ProductWorm Protector 2X Canine Anthelmintic
Active ingredientpyrantel pamoate
Label structure12 sections

Storage and handling

RECOMMENDED STORAGE: STORE BELOW 86ºF (30ºC). REV102025 | Item Number: 1792 PRODUCT LOT & EXPIRATION DATE PRINTED ON BOTTOM OF CONTAINER ▼

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

WORM PROTECTOR®2X
(pyrantel pamoate oral suspension)
Canine Anthelmintic Suspension

Active Ingredient: 4.54 mg of Pyrantel Base as Pyrantel Pamoate per mL
NOT FOR USE IN HUMANS
Approved by FDA under ANADA # 200-007
NET CONTENTS - fl. oz. (60 mL)

DOSAGE & ADMINISTRATION SECTION

IMPORTANT: SHAKE WELL BEFORE USING

DOSAGE AND ADMINISTRATION: Administer 1 teaspoon (5 mL) for each 10 lb of body weight. It is not necessary to withhold food prior to or after treatment. Dogs usually find this dewormer very palatable and will lick the dose from the bowl willingly. If there is reluctance to accept the
dose, mix in a small quantity of dog food to encourage consumption. It is recommended that dogs maintained under conditions of constant exposure to worm infestation should have a follow-up fecal exam within 2-4 weeks after treatment. For maximum control and prevention of reinfestation, it is recommended that puppies be treated at 2, 3, 4, 6, 8, and 10 weeks of age. Lactating bitches should be treated 2-3 weeks after whelping. Adult dogs kept in heavily contaminated quarters may be treated at monthly intervals to prevent T. canis reinfestation.

STORAGE AND HANDLING SECTION

RECOMMENDED STORAGE: STORE BELOW 86ºF (30ºC).
REV102025 | Item Number: 1792

PRODUCT LOT & EXPIRATION DATE PRINTED ON BOTTOM OF CONTAINER ▼

USER SAFETY WARNINGS SECTION

KEEP OUT OF REACH OF CHILDREN. Keep WORM PROTECTOR 2X in a secure location out of reach of dogs, cats, and other animals to prevent accidental ingestion or overdose.

DESCRIPTION SECTION

WORM PROTECTOR®2X (pyrantel pamoate oral suspension)
Canine Anthelmintic Suspension

NOT FOR USE IN HUMANS
DESCRIPTION: WORM PROTECTOR 2X Liquid Wormer is a suspension of pyrantel pamoate in a palatable butterscotch flavored vehicle. Each mL contains 4.54 mg of pyrantel base as pyrantel pamoate.

Pyrantel pamoate is a compound belonging to a family classified chemically as tetrahydropyrimidines. It is a yellow, water-insoluble crystalline salt of the tetrahydropyrimidine base and pamoic acid containing 34.7% base activity. The chemical structure and name are given to the right:

Chemical FormulaChemical Formula

SPL UNCLASSIFIED SECTION

INDICATIONS AND USAGE: WORM PROTECTOR 2X suspension is a highly palatable formulation intended as a single treatment for the removal of large roundworms (Toxocara canis and Toxascaris leonina) and hookworms (Ancylostoma caninum and Uncinaria stenocephala) in dogs and puppies. The presence of these parasites should be confirmed by laboratory fecal exam. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.

WORM PROTECTOR 2X suspension may also be used to prevent reinfestation of T. canis in puppies and adult dogs and in lactating bitches after whelping.

GENERAL PRECAUTIONS SECTION

PRECAUTIONS: THIS PRODUCT IS A SUSPENSION AND AS SUCH WILL SEPARATE. TO ENSURE UNIFORM RESUSPENSION AND TO ACHIEVE
PROPER DOSAGE, IT IS EXTREMELY IMPORTANT THAT THE PRODUCT BE SHAKEN THOROUGHLY BEFORE EVERY USE.
KEEP OUT OF REACH OF CHILDREN

DOSAGE AND ADMINISTRATION: Administer 1 teaspoon (5 mL) for each 10 lb of body weight. It is not necessary to withhold food prior to or after treatment. Dogs usually find this dewormer very palatable and will lick the dose from the bowl willingly. If there is reluctance to accept the
dose, mix in a small quantity of dog food to encourage consumption. It is recommended that dogs maintained under conditions of constant exposure to worm infestation should have a follow-up fecal exam within 2-4 weeks after treatment. For maximum control and prevention of reinfestation, it is recommended that puppies be treated at 2, 3, 4, 6, 8, and 10 weeks of age. Lactating bitches should be treated 2-3 weeks after whelping. Adult dogs kept in heavily contaminated quarters may be treated at monthly intervals to prevent T. canis reinfestation.

For maximum control and prevention of reinfestation, it is recommended that puppies be treated at 2, 3, 4, 6, 8, and 10 weeks of age. Lactating bitches should be treated 2-3 weeks after whelping. Adult dogs kept in heavily contaminated quarters may be treated at monthly intervals to prevent T. canis reinfestation.

SUMMARY OF SAFETY AND EFFECTIVENESS

SAFETY AND EFFICACY STUDIES: Critical (worm count) studies in dogs demonstrated that pyrantel pamoate at the recommended dosage is highly efficacious against T. leonina (99%), T. canis (85%), A. caninum (97%), and U. stenocephala (94%).

One of the most outstanding and significant features of pyrantel pamoate is its wide margin of therapeutic safety in dogs. The acute oral LD(50) of pyrantel pamoate administered in gelatin capsules to female and male dogs is greater than 314 mg base per lb of body weight, which indicates a therapeutic index in excess of 138 times the recommended dosage. In subacute and chronic studies, no significant morphological abnormalities could be attributed to pyrantel pamoate when administered to dogs at daily dose rates up to 94 mg base per pound of body weight (40x) for periods of 19, 30, and 90 days. Clinical studies conducted in a wide variety of geographic locations using more than 40 different breeds of dogs showed no drug-induced toxic effects. Included in these studies were nursing pups, weaned pups, adults, pregnant bitches, and males at stud.

Additional data has demonstrated the safe use of pyrantel pamoate in dogs having heartworm infestations and/or receiving medication for heartworms, dogs exposed to organophosphate flea collars or flea/tick-dip treatments, and dogs undergoing concurrent treatment or medication at the time of worming such as immunization and antibacterial treatment.

STORAGE AND HANDLING SECTION

RECOMMENDED STORAGE: STORE BELOW 86° F (30° C). Keep WORM PROTECTOR 2X in a secure location out of reach of dogs, cats, and other animals to prevent accidental ingestion or overdose.

HOW SUPPLIED SECTION

HOW SUPPLIED: WORM PROTECTOR 2X is supplied in 2 fl. oz. (60 mL), 8 fl. oz. (236 mL), and 16 fl. oz. (474 mL) bottles.

Approved by FDA under ANADA # 200-007

Take TimeTake Time

ADVERSE REACTIONS SECTION

Contact Information: To report suspected adverse events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact Huvepharma, Inc. at 1-877-994-4883 or www.huvepharma.us. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or www.fda.gov/reportanimalae

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Worm Protector 2X 10-2025 2 oz_bw p1Worm Protector 2X 10-2025 2 oz_bw p1

Worm Protector 2X 10-2025 2 oz bw p2Worm Protector 2X 10-2025 2 oz bw p2

Worm Protector 2X 10-2025 2 oz_bw p3Worm Protector 2X 10-2025 2 oz_bw p3

Worm Protector 2X 10-2025 2 oz_bw p4Worm Protector 2X 10-2025 2 oz_bw p4

Worm Protector 2X 10-2025 2 oz bw p5Worm Protector 2X 10-2025 2 oz bw p5

Worm Protector 2X 10-2025 8 oz_p1Worm Protector 2X 10-2025 8 oz_p1

Worm Protector 2X 10-2025 8 oz_p2Worm Protector 2X 10-2025 8 oz_p2

Worm Protector 2X 10-2025 8 oz p3Worm Protector 2X 10-2025 8 oz p3

Worm Protector 2X 10-2025 2 oz_bw p1
Worm Protector 2X 10-2025 2 oz_bw p1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
882492pyrantel pamoate 4.54 MG/mL Oral SuspensionPSN5
1432149Worm Protector 2X 4.54 MG/mL Oral SuspensionPSN5
1432149pyrantel 4.54 MG/ML Oral Suspension [Worm Protector 2X]SBD5
882492pyrantel 4.54 MG/ML Oral SuspensionSCD5
882492pyrantel (as pyrantel pamoate) 4.54 MG/ML Oral SuspensionSY5
1432149pyrantel (as pyrantel pamoate) 4.54 MG/ML Oral Suspension [Worm Protector 2X]SY5
1432149Worm Protector 2X 4.54 MG/ML Oral SuspensionSY5

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
23243-1450-2Worm Protector 2XCanine Anthelmintic60 mL in 1 BOTTLE, PLASTICSUSPENSION605
23243-1450-8Worm Protector 2XCanine Anthelmintic236 mL in 1 BOTTLE, PLASTICSUSPENSION2365

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
23243-145023243-1450-2, 23243-1450-8

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
NameUNIIKind
pyrantel pamoate81BK194Z5MACTIM

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 15 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PINRIDPYRANTEL PAMOATEYYBA CORP59da86a4-db0d-4551-9128-e09a4e85cd782026-05-25WarningsName fallback
generic name: PYRANTEL PAMOATE
PINRIDPYRANTEL PAMOATEYYBA CORP52a9b5c8-08e6-b91e-e063-6294a90a0e0d2026-05-25WarningsName fallback
generic name: PYRANTEL PAMOATE
pinworm treatmentPYRANTEL PAMOATEBIONPHARMA INC.3cf96d04-e8bc-31af-e063-6294a90a0db82026-01-23WarningsName fallback
generic name: PYRANTEL PAMOATE
pinworm treatmentPYRANTEL PAMOATEAMERISOURCE BERGEN4837905f-1037-a319-e063-6294a90aba042026-01-21WarningsName fallback
generic name: PYRANTEL PAMOATE
Pyrantel PamoatePYRANTEL PAMOATEJefferson Labse862b337-2991-4b56-8584-fd80dccd725f2025-12-19WarningsName fallback
generic name: PYRANTEL PAMOATE
pinworm treatmentPYRANTEL PAMOATESTRATEGIC SOURCING SERVICES453c0645-f2b4-aa4a-e063-6294a90af1fb2025-12-05WarningsName fallback
generic name: PYRANTEL PAMOATE
PARASITOLPYRANTEL PAMOATEMenper Distributors Inc.cd5eb4c9-d0f0-4be7-84eb-88ebc4632dc62025-07-22WarningsName fallback
generic name: PYRANTEL PAMOATE
PINRIDPYRANTEL PAMOATEYYBA CORPfc225b5b-0ce8-4394-a643-39dbc674d7cd2025-07-02WarningsName fallback
generic name: PYRANTEL PAMOATE
MebendamaX PinwormPYRANTEL PAMOATEPharmadel LLC1d75b912-3550-7d4c-e063-6294a90ad5fa2025-06-18WarningsName fallback
generic name: PYRANTEL PAMOATE
Pyrantel PamoatePYRANTEL PAMOATEProMex LLCe68c503a-6f79-4f83-a6f3-c12a13fb06a02024-12-18WarningsName fallback
generic name: PYRANTEL PAMOATE
Pinworm MedicinePYRANTEL PAMOATEREESE PHARMACEUTICAL CO.f23d5092-48ca-46c4-830a-c34d0a3a7f572024-12-18WarningsName fallback
generic name: PYRANTEL PAMOATE
Walgreens Pinworm MedicinePYRANTEL PAMOATEWalgreens7fd58448-6846-4d8e-994c-d0ca2fd38e682024-12-18WarningsName fallback
generic name: PYRANTEL PAMOATE
CVS Pinworm TreatmentPYRANTEL PAMOATECVS PHARMACY INCd079008a-c87a-45f2-8775-0e40241761f02024-12-18WarningsName fallback
generic name: PYRANTEL PAMOATE
VRMX 500PYRANTEL PAMOATEOPMX LLCe119cad8-9814-7d5a-e053-2995a90afde52024-02-06WarningsName fallback
generic name: PYRANTEL PAMOATE
Pyrantel PamoatePYRANTEL PAMOATEProMex LLCe68dd24a-93f8-4e2e-a698-d9ad9a7cebac2018-01-02WarningsName fallback
generic name: PYRANTEL PAMOATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.