PYRANTEL PAMOATE suspension

Pyrantel Pamoate by

Drug Labeling and Warnings

Pyrantel Pamoate by is a Otc medication manufactured, distributed, or labeled by Jefferson Labs. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PURPOSE

Pyrantel Pamoate Oral Suspension is used for the treatment of pinworms.

Drug Facts

• Active Ingredient: Purpose
• Pyrantel base: Pinworm
• (as Pyrantel Pamoate) 50 mg: treatment

Uses

• For pinworm treatment

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.

Do not use

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

When using this product

• Shake well before use.

Directions

• Adults and children 2 years to 12 years of age may take this product. Take the dosage in Table I according to the body weight of the individual treated. Do not exceed 4 teaspoonful (20.0 mL) of Pyrantel Pamoate Oral Suspension.
• 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 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).

Table 1.Pyrantel Pamoate Oral Suspension Dosage Guide

• Less than 25 lbs. (11 Kg) or under 2 years old:

  Do not use unless

  directed by a physician

• 25-37 lbs. (11-16 kg): 1/2 teaspoonful (2.5 mL)
• 38-62 lbs. (17-28 kg): 1 teaspoonful (5.0 mL)
• 63-87 lbs. (29-39 kg): 1 1/2 teaspoonful (7.5 mL)
• 88-112 lbs. (40-50 kg): 2 teaspoonful (10.0 mL)
• 113-137 lbs. (51-62 kg): 2 1/2 teaspoonful (12.5 mL)
• 138-162 lbs. (63-73 kg): 3 teaspoonful (15.0 mL)
• 163-187 lbs. (74-84 kg): 3 1/2 teaspoonful (17.5 mL)
• 188 lbs. (85 kg and over): 4 teaspoonful (20.0 mL)

Other Information

Each teaspoonful contains: Potassium 5 mg.

STORAGE AND HANDLING

Store 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

Questions? 1-888-215-1256

SPL UNCLASSIFIED SECTION

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
888-215-1256
IN 50-1419  01/2018

KEEP OUT OF REACH OF CHILDREN

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)

INGREDIENTS AND APPEARANCE

PYRANTEL PAMOATE 
pyrantel pamoate suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51072-088
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRANTEL PAMOATE (UNII: 81BK194Z5M) (PYRANTEL - UNII:4QIH0N49E7)	PYRANTEL	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	white	Score
Shape		Size
Flavor	VANILLA (custard)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51072-088-00	946 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/21/2015
2	NDC: 51072-088-01	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/28/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part357B	11/21/2015

Labeler - Jefferson Labs (832848639)

Establishment
Name	Address	ID/FEI	Business Operations
Jefferson Labs		832848639	manufacture(51072-088)