Pyrantel Pamoate

Manufacturer
ProMex LLC
Effective date
2018-01-02
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:54:08

Label at a glance#

ProductPyrantel Pamoate
Active ingredientPyrantel Pamoate
Label structure9 sections

Dosage and administration

Adults, children 12 years of age and over, and children 2 years to under 12 years of age: Oral dosage is a single dose of 5 milligrams of pyrantel base per pound, or 11 milligrams per kilogram, of body weight. Do not exceed 1 gram (1000 mg). Weight Dosage (Taken as a single dose) READ INSERT CAREFULLY BEFORE USE 25-37 lb 2 tablet 38-62 lbs 4 tablets 63-87 lbs 6 tablets 88-112 lbs 8 tablets 113-137 lbs 10 tablets 1...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Pyrantel Pamoate 180 mg (62.5mg pyrantel base per 180 mg of pyrantel pamoate)

PURPOSE

OTC - PURPOSE SECTION

Anthelmintic

Use

INDICATIONS & USAGE SECTION

for the treatment of Pinworms.

Warnings

WARNINGS SECTION

OTC - ASK DOCTOR SECTION

Abdominal cramps, nausea, vomiting, diarrhea, headache, or dizziness sometimes occur after taking this drug. If any of these conditions persist consult a doctor

  • If you are pregnant or have liver disease, don't take this product unless directed by a doctor.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults, children 12 years of age and over, and children 2 years to under 12 years of age: Oral dosage is a single dose of 5 milligrams of pyrantel base per pound, or 11 milligrams per kilogram, of body weight. Do not exceed 1 gram (1000 mg).

WeightDosage (Taken as a single dose)
READ INSERT CAREFULLY BEFORE USE
25-37 lb2 tablet
38-62 lbs4 tablets
63-87 lbs6 tablets
88-112 lbs8 tablets
113-137 lbs10 tablets
138-162 lbs12 tablets
163-187 lbs14 tablets
over 188 lbs16 tablets

Take only according to directions and don't exceed recommended dosage unless directed by a doctor. Medication should only be taken one time as a single dose; do not repeat treatment unless directed by a doctor. When one individual in house hold has pinworms, the entire household should be treated unless otherwise advised. See Warnings. If any worms other than pinworms are present before or after treatment, consult a doctor. If any symptoms or pinworms are still present after treatment consult a doctor

  • This product can be taken any time of day, with or without meals. It may be taken alone or with milk or fruit juice. Use of a laxative is not necessary prior to, during, or after medication.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of Reach of Children. In case of accidental overdose/ingestion contact a poison control center immediately.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Croscarmellose Sodium, Crospovidone, Dicalcium Phosphate, Magnesium Stearate, Microcrystalline Cellulose

PRINCIPAL DISPLAY PANEL - 20 Tablet Blister Pack Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

VERMISOL
TABLET

Contains 20 Tablets

PRINCIPAL DISPLAY PANEL - 20 Tablet Blister Pack Carton
PRINCIPAL DISPLAY PANEL - 20 Tablet Blister Pack Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
199107pyrantel pamoate 180 MG Oral TabletPSN2
199107pyrantel 180 MG Oral TabletSCD2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58988-1760-1Pyrantel Pamoate2 in 1 CARTONTABLET22
58988-1760-1Pyrantel Pamoate10 in 1 BLISTER PACKTABLET102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58988-1760PYRANTEL PAMOATE TABLET [PROMEX LLC]2Current NDC, Legacy NDC, 2 package rows20180112_e68dd24a-93f8-4e2e-a698-d9ad9a7cebac.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58988-176058988-1760-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pyrantel PamoatePYRANTEL PAMOATEProMex LLCe68dd24a-93f8-4e2e-a698-d9ad9a7cebac2018-01-02WarningsExact identifier
ndc (package): 58988-1760-1
ndc (product): 58988-1760
ndc11 (package): 58988176001
spl id: 590596c7-cde5-419a-b5d2-759b8d996fba
spl set id: e68dd24a-93f8-4e2e-a698-d9ad9a7cebac

Reported adverse events (FAERS/openFDA)#

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