NDC 51072-088 Pyrantel Pamoate
Suspension Oral

Product Information

Product Code51072-088
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Pyrantel Pamoate
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Pyrantel Pamoate
Product Type What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
Human Otc Drug
Dosage FormSuspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.
Administration Route(s) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Oral - Administration to or by way of the mouth.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Jefferson Labs
Labeler Code51072
FDA Application Number What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
part357B
Marketing Category What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
11-21-2015
Listing Expiration Date What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.
12-31-2023
Exclude Flag What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
N
NDC Code Structure

Usage Information


Product Characteristics

Color(s)WHITE (C48325)
Flavor(s)VANILLA (C73421 - CUSTARD)

Product Packages

NDC 51072-088-00

Package Description: 946 mL in 1 BOTTLE

NDC 51072-088-01

Package Description: 473 mL in 1 BOTTLE

NDC 51072-088-02

Package Description: 946 mL in 1 BOTTLE

NDC 51072-088-03

Package Description: 473 mL in 1 BOTTLE

Product Details

Pyrantel Pamoate is a human over the counter drug product labeled by Jefferson Labs. The product's dosage form is suspension and is administered via oral form.


What are Pyrantel Pamoate Active Ingredients?

The following is the list of active ingredients in this product. An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.


NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct code indicates a single concept unique identifier (RXCUI) is associated with this product:


Inactive Ingredient(s)

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • 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)


* Please review the disclaimer below.

Patient Education

Pyrantel

Pyrantel is pronounced as (pi ran' tel)

Why is pyrantel medication prescribed?
Pyrantel, an antiworm medication, is used to treat roundworm, hookworm, pinworm, and other worm infections.This medication is sometimes prescribed for other uses; ask you...
[Read More]

* Please review the disclaimer below.

Pyrantel Pamoate Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Otc - Purpose



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


Drug Facts



Active IngredientPurpose
 Each 1 mL contains:
 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.


Otc - Questions



Questions? 1-888-215-1256


Other



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  07/2015


Otc - 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)


* Please review the disclaimer below.