Pyrantel

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This page reprints a manufacturer label. Everything below in quotation marks is copied from NEMEX ® -2, published by FDA and retrieved on 2026-09-16. Nothing has been added, reworded or left out of the sections shown. It is the manufacturer’s label, reproduced as published.

This page reprints the FDA label for NEMEX ® -2 by Zoetis Inc, a pyrantel product labelled for dogs. The sections below are copied from that label without change, with the set id and the date it was retrieved from DailyMed. 1 other stored label carries the same active ingredient and is listed at the end.

The label

Product: NEMEX ® -2. Manufacturer: Zoetis Inc. FDA Structured Product Label set id d2d6dcd1-7835-4c7b-bbae-d14752d9983b. Label effective 2025-10-23. Retrieved 2026-09-16 from the DailyMed animal label release, and readable on DailyMed.

Indications

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

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. SAFETY AND EFFICACY STUDIES Critical (worm count) studies in dogs demonstrated that Nemex-2 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 Nemex-2 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 Nemex-2 when administered to dogs at daily dose rates up to 94 mg base per lb 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 have demonstrated the safe use of Nemex-2 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. RECOMMENDED STORAGE Store below 30°C (86°F).

Precautions

THIS PRODUCT IS A SUSPENSION AND AS SUCH WILL SEPARATE. TO INSURE 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

Description

Nemex-2 is a suspension of pyrantel pamoate in a palatable caramel-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 below: (E )-1,4,5,6-Tetrahydro-1-methyl-2-[2-(2-thienyl) vinyl] pyrimidine 4,4' methylenebis [3-hydroxy-2-naphthoate] (1:1) Chemical Structure

Other labels for this ingredient

These labels are also stored for the same active ingredient. They are not identical to the one reprinted above, and each is listed by product and set id rather than merged with it.

  • RFD ®, Zoetis Inc.. Set id bbbcff04-e023-43c0-aeb5-a8f747d79fd4.

FDA adverse event reports

The FDA Center for Veterinary Medicine publishes the adverse event reports it receives through openFDA. The counts below are the reports naming pyrantel as an active ingredient for each species this label names, as returned on 2026-09-16, coded by the VeDDRA reaction term the reporter chose. Reactions are counted per report, so one report can appear under several terms.

These are counts, not rates. Reporting is voluntary, the number of animals treated is not known, and a widely used product accumulates reports for that reason alone. A report records that an event followed a dose; it does not establish that the product caused it. The counts say nothing about how one product compares with another.

Dogs: 229,742 reports

Reactions most often coded in dogs, 229,742 reports
VeDDRA reaction termReports
Vomiting37,307
INEFFECTIVE, HEARTWORM LARVAE35,850
Lack of efficacy (endoparasite) - hookworm31,823
Lack of efficacy (endoparasite) - heartworm28,953
Digestive tract disorder NOS16,793
Diarrhoea15,908
INEFFECTIVE, ASCARIDS NOS11,932
Cardiac disorder NOS10,065
Lethargy (see also Central nervous system depression in 'Neurological')9,427
Lack of efficacy (endoparasite) - roundworm NOS9,179
Lack of efficacy - NOS8,770
Seizure NOS7,555
INEFFECTIVE, HOOKS7,207
Lack of efficacy (bacteria) - Borrelia6,998
Lack of efficacy (endoparasite) - tapeworm4,134

Outcome as recorded by the reporter: Outcome Unknown 81,734; Ongoing 48,166; Recovered/Normal 40,486; Recovered with Sequela 16,588; Died 3,709; Euthanized 1,599.

Queries: reports, reactions, outcomes. Dataset: openFDA Animal and Veterinary Adverse Event Reports.

Sources

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