OTC Medication Information: Pyrantel Pamoate

PYRANTEL PAMOATE- pyrantel pamoate suspension
Jefferson Labs

50 mg/mL Pyrantel Base

Pharmacy Bulk Pack

Drug Facts

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

Indications

  • For the treatment of pinworms.

Warnings

  • 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

  • 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

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

Weight Dosage (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 pounds 1/2 teaspoonful (125 mg)
38 to 62 pounds 1 teaspoonful (250 mg)
63 to 87 pounds 1 1/2 teaspoonfuls (375 mg)
88 to 112 pounds 2 teaspoonfuls (500 mg)
113 to 137 pounds 2 1/2 teaspoonfuls (625 mg)
138 to 162 pounds 3 teaspoonfuls (750 mg)
163 to 187 pounds 3 1/2 teaspoonfuls (875 mg)
188 pounds and over 4 teaspoonfuls (1,000 mg)

Other Information

Each teaspoonful contains: Potassium 5 mg.

Store upright at 20°–25° C (68°–77° F). Excursions permitted between 15°–30° C (59°–86° F). Do not freeze.

Inactive Ingredients

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

Questions? 1-888-215-1256

PEEL BACK AT CORNER FOR IMPORTANT PRODUCT INFORMATION

MANUFACTURED IN THE USA

take 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 03/2021

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Keep Out of Reach of Children

PRINCIPAL DISPLAY PANEL — 946 mL Bottle Label

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 -- 32 oz Bottle Label
(click image for full-size original)
PYRANTEL PAMOATE
pyrantel pamoate suspension
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:51072-088
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PYRANTEL PAMOATE (PYRANTEL) PYRANTEL 50 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE
POTASSIUM SORBATE
GLYCERIN
SODIUM BENZOATE
SUCRALOSE
XANTHAN GUM
WATER
Product Characteristics
Color white Score
Shape Size
Flavor VANILLA (custard) Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51072-088-00 946 mL in 1 BOTTLE None
2 NDC:51072-088-02 946 mL in 1 BOTTLE None
3 NDC:51072-088-01 473 mL in 1 BOTTLE None
4 NDC:51072-088-03 473 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M024 11/21/2015
Labeler — Jefferson Labs (832848639)
Establishment
Name Address ID/FEI Operations
Jefferson Labs 832848639 manufacture (51072-088)

Revised: 12/2023 Jefferson Labs

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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