FDA.reportPublic FDA data

ORAL-PRO ® Pyrantel Pamoate Oral Suspension Pinworm Treatment

Manufacturer
Jefferson Labs
Effective date
2025-12-19
Label type
HUMAN OTC DRUG LABEL
Version
16
Source
full-release
Hydrated at
2026-06-01 01:27:29

Label at a glance#

ProductPyrantel Pamoate
Active ingredientPYRANTEL PAMOATE
Label structure14 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 not to exceed 1 gram. Carefully read additional product information (located on the inside of label) before using this medication. Take only according to directions and do not exceed th...

Storage and handling

Store upright up to 25° C (77° F) with brief excursions 40° C (104° F). DO NOT FREEZE.

Label contents#

Full prescribing information#

OTC - PURPOSE SECTION

50 mg/mL Pyrantel Base

Pharmacy Bulk Pack

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active IngredientPurpose
 Each 1 mL contains:
 Pyrantel base Pinworm
 (as Pyrantel Pamoate) 50 mg treatment

Indications

INDICATIONS & USAGE SECTION

  • For the treatment of pinworms.

Warnings

WARNINGS SECTION

  • Abdominal cramps, nausea, vomiting, diarrhea, headache or dizziness sometimes occur after taking this drug. If any of these conditions persist, consult a physician.
  • Keep this and all medications out of reach of children.
  • In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.
  • If you are pregnant or have liver disease, do not take this product unless directed by a physician.

Directions

INSTRUCTIONS FOR USE 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 not to exceed 1 gram.
  • Carefully read additional product information (located on the inside of label) before using this medication. Take only according to directions and do not exceed the recommended dosage unless directed by a physician. Medication should only be taken one time as a single dose, do not repeat treatment unless directed by a physician. 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 physician. If any symptoms or pinworms are still present after treatment, consult a physician.
  • 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.

Dosage Information

DOSAGE FORMS & STRENGTHS SECTION

Each mL of Pyrantel Pamoate Oral Suspension contains the equivalent of 50 mg of Pyrantel Base (as Pyrantel Pamoate).

Pyrantel Pamoate Oral Suspension Dosage Guide

DOSAGE & ADMINISTRATION SECTION

WeightDosage (taken as a single dose)

Less than 25 pounds or

under 2 years old

Do not use unless directed by

a physician

 25 to 37 pounds1/2 teaspoonful (125 mg)
 38 to 62 pounds1 teaspoonful (250 mg)
 63 to 87 pounds1 1/2 teaspoonfuls (375 mg)
 88 to 112 pounds2 teaspoonfuls (500 mg)
 113 to 137 pounds2 1/2 teaspoonfuls (625 mg)
 138 to 162 pounds3 teaspoonfuls (750 mg)
 163 to 187 pounds3 1/2 teaspoonfuls (875 mg)
 188 pounds and over4 teaspoonfuls (1,000 mg)

Other Information

OTHER SAFETY INFORMATION

Each teaspoonful contains: Potassium 5 mg.

STORAGE AND HANDLING SECTION

Store upright up to 25° C (77° F) with brief excursions 40° C (104° F). DO NOT FREEZE.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Citric acid, potassium sorbate, purified water, glycerin, sodium benzoate, sucralose, vanilla custard flavor, xanthan gum.

OTC - QUESTIONS SECTION

Questions? 1-888-215-1256

SPL UNCLASSIFIED SECTION

PEEL BACK AT CORNER FOR IMPORTANT PRODUCT INFORMATION

MANUFACTURED IN THE USA

take timetake time

Do not use if the seal is open or broken.

REORDER NO: 21013

Manufactured by:
Jefferson Labs
NORTHFIELD, MINNESOTA 55057
1-888-215-1256
IN 50-1419  12/2024

logologo

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep Out of Reach of Children

PRINCIPAL DISPLAY PANEL - 946 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 51072-088-00

ORAL-PRO®

Pyrantel Pamoate

Oral Suspension

Pinworm Treatment

50 mg/mL Pyrantel Base

Pharmacy Bulk Pack

Keep Out of Reach of Children

32 fl. oz. (946 mL)

Principal Display Panel - 32oz Bottle LabelPrincipal Display Panel - 32oz Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
312733pyrantel pamoate 50 MG/mL Oral SuspensionPSN16
312733pyrantel 50 MG/ML Oral SuspensionSCD16
312733pyrantel (as pyrantel pamoate) 50 MG/ML Oral SuspensionSY16

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51072-088-00Pyrantel Pamoate946 mL in 1 BOTTLESUSPENSION94616
51072-088-01Pyrantel Pamoate473 mL in 1 BOTTLESUSPENSION47316
51072-088-02Pyrantel Pamoate946 mL in 1 BOTTLESUSPENSION94616
51072-088-03Pyrantel Pamoate473 mL in 1 BOTTLESUSPENSION47316
51072-088-04Pyrantel Pamoate237 mL in 1 BOTTLESUSPENSION23716

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
51072-08851072-088-00, 51072-088-02, 51072-088-01, 51072-088-03, 51072-088-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
PYRANTEL PAMOATE81BK194Z5MACTIM
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
GLYCERINPDC6A3C0OXIACT
SODIUM BENZOATEOJ245FE5EUIACT
SUCRALOSE96K6UQ3ZD4IACT
XANTHAN GUMTTV12P4NEEIACT
WATER059QF0KO0RIACT

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 PAMOATEJefferson Labse862b337-2991-4b56-8584-fd80dccd725f2025-12-19WarningsExact identifier
ndc (package): 51072-088-03
ndc (package): 51072-088-00
ndc (package): 51072-088-01
ndc (package): 51072-088-02
ndc (package): 51072-088-04
ndc (product): 51072-088
ndc11 (package): 51072008803
ndc11 (package): 51072008801
ndc11 (package): 51072008802
ndc11 (package): 51072008800
ndc11 (package): 51072008804
spl id: 7406132d-3c90-4bea-8a2d-c71873601f0c
spl set id: e862b337-2991-4b56-8584-fd80dccd725f

Reported adverse events (FAERS/openFDA)#

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