NDC 51072-088 Pyrantel Pamoate

Pyrantel Pamoate

NDC Product Code 51072-088

NDC 51072-088-00

Package Description: 946 mL in 1 BOTTLE

NDC 51072-088-01

Package Description: 473 mL in 1 BOTTLE

NDC Product Information

Pyrantel Pamoate with NDC 51072-088 is a a human over the counter drug product labeled by Jefferson Labs. The generic name of Pyrantel Pamoate is pyrantel pamoate. The product's dosage form is suspension and is administered via oral form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 312733.

Dosage Form: Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.

Product Type: Human Otc Drug 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.

Pyrantel Pamoate Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.


Inactive Ingredient(s)

About the 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)

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.

Labeler Name: Jefferson Labs
Labeler Code: 51072
FDA Application Number: part357B 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.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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.

Start Marketing Date: 11-21-2015 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 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.

Exclude Flag: N - NO 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".

* Please review the disclaimer below.

Information for Patients

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 Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

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 oldDo not use unlessdirected 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 INFORMATIONMANUFACTURED IN THE USADo not use if the seal is open or broken.REORDER NO: 21013Manufactured by:Jefferson LabsNORTHFIELD, MINNESOTA 55057888-215-1256IN 50-1419  07/2015

Otc - Keep Out Of Reach Of Children

Keep Out of Reach of Children

* Please review the disclaimer below.