Pyrantel Pamoate

Manufacturer
ProMex LLC
Effective date
2024-12-18
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:48:00

Label at a glance#

ProductPyrantel Pamoate
Active ingredientPyrantel Pamoate
Label structure9 sections

Dosage and administration

Shake well before use. 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) Under 25 lbs or 2 yrs. Don't use unless directed by a doctor 25-37 lbs ½ teaspoonful 38-62 lbs 1 teaspoonful 63-8...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient (in each 1mL)

OTC - ACTIVE INGREDIENT SECTION

Pyrantel Pamoate 144 mg/mL
(50mg pyrantel base per mL)

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 occurs after taking this drug. If any of these conditions persist, consult a doctor.

OTC - PREGNANCY OR BREAST FEEDING SECTION

*If you are pregnant or have liver disease, do not take this product unless directed by a doctor.

Directions

DOSAGE & ADMINISTRATION SECTION

Shake well before use. 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)
Under 25 lbs or 2 yrs.Don't use unless directed by a doctor
25-37 lbs½ teaspoonful
38-62 lbs1 teaspoonful
63-87 lbs1 ½ teaspoonful
88-112 lbs2 teaspoonful
113-137 lbs2 ½ teaspoonful
138-162 lbs3 teaspoonful
163-187lbs3 ½ teaspoonful
over 188 lbs4 teaspoonful

*Read package insert carefully before taking this medication. Take only according to directions and do not exceed the 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 a household 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

Purified Water, Glycerin, Sugar, Flavor, Xanthan Gum, Citric Acid, Sodium Benzoate and Potassium Sorbate

PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

VERMISOL

SUSPENSION

1 oz (30 ml)

PRINCIPAL DISPLAY PANEL - 30 ml Bottle CartonPRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
199106pyrantel pamoate 144 MG in 1 mL Oral SuspensionPSN5
199106pyrantel pamoate 144 MG/ML Oral SuspensionSCD5
199106pyrantel pamoate 144 MG per 1 ML Oral SuspensionSY5
199106pyrantel pamoate 144 MG/ML (pyrantel base 50 MG/ML) Oral SuspensionSY5

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58988-1770-12022-01-30C16284748780-1d6a99b39-6c42-a426-e053-dadaa90af4c2Pyrantel Pamoate
58988-1770-12022-01-28C16284748780-1d6a99b39-6c42-a426-e053-dadaa90af4c2Pyrantel Pamoate

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58988-1770-1Pyrantel Pamoate1 in 1 CARTONSUSPENSION15
58988-1770-1Pyrantel Pamoate30 mL in 1 BOTTLESUSPENSION305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58988-1770PYRANTEL PAMOATE SUSPENSION [PROMEX LLC]5Current NDC, Legacy NDC, 2 package rows20241222_e68c503a-6f79-4f83-a6f3-c12a13fb06a0.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58988-177058988-1770-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 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 LLCe68c503a-6f79-4f83-a6f3-c12a13fb06a02024-12-18WarningsExact identifier
ndc (package): 58988-1770-1
ndc (product): 58988-1770
ndc11 (package): 58988177001
spl id: 26fb5b42-2803-4e62-a944-b0b31ad5ba60
spl set id: e68c503a-6f79-4f83-a6f3-c12a13fb06a0

Reported adverse events (FAERS/openFDA)#

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