oral-pro®

oral-pro®
SPL v16
SPL
SPL Set ID e862b337-2991-4b56-8584-fd80dccd725f
Route
oral
Published
Effective Date 2025-04-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
pyrantel (50 mg)
Inactive Ingredients
citric acid monohydrate potassium sorbate glycerin sodium benzoate sucralose xanthan gum water

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2015-11-21

Description

50 mg/mL Pyrantel Base Pharmacy Bulk Pack


Medication Information

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.
Other Information

Each teaspoonful contains: Potassium 5 mg.

Inactive Ingredients

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

Description

50 mg/mL Pyrantel Base Pharmacy Bulk Pack

Section 42229-5

PEEL BACK AT CORNER FOR IMPORTANT PRODUCT INFORMATION

MANUFACTURED IN THE USA

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

Section 44425-7

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

Section 50565-1

Keep Out of Reach of Children

Section 53413-1

Questions? 1-888-215-1256

Section 55105-1

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.
Dosage Information

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

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)

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)


Structured Label Content

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.
Other Information

Each teaspoonful contains: Potassium 5 mg.

Inactive Ingredients

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

Section 42229-5 (42229-5)

PEEL BACK AT CORNER FOR IMPORTANT PRODUCT INFORMATION

MANUFACTURED IN THE USA

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

Section 44425-7 (44425-7)

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

Section 50565-1 (50565-1)

Keep Out of Reach of Children

Section 53413-1 (53413-1)

Questions? 1-888-215-1256

Section 55105-1 (55105-1)

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.
Dosage Information

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

Principal Display Panel 946 Ml Bottle Label (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)

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)


Advanced Ingredient Data


Raw Label Data

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