NDC 58988-1760 Pyrantel Pamoate
Tablet Oral

Product Information

Pyrantel Pamoate is a human over the counter drug product labeled by Promex Llc. The product's dosage form is tablet and is administered via oral form.

Product Code58988-1760
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 FormTablet - A solid dosage form containing medicinal substances with or without suitable diluents.
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.
Promex Llc
Labeler Code58988
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.
09-27-2002
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.
12-31-2022
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

What are the uses for Pyrantel Pamoate?


Product Characteristics

Color(s)YELLOW (C48330)
ShapeROUND (C48348)
Size(s)11 MM
Score1

Product Packages

NDC 58988-1760-1

Package Description: 2 BLISTER PACK in 1 CARTON > 10 TABLET in 1 BLISTER PACK

Product Details

What are Pyrantel Pamoate Active Ingredients?

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 indicates multiple concept unique identifiers (RXCUIs) are 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.
  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)

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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]

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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



Other



Drug Facts


Active Ingredient (In Each Tablet)



Pyrantel Pamoate 180 mg (62.5mg pyrantel base per 180 mg of pyrantel pamoate)


Purpose



Anthelmintic


Use



for the treatment of Pinworms.


Otc - Ask Doctor



Abdominal cramps, nausea, vomiting, diarrhea, headache, or dizziness sometimes occur after taking this drug. If any of these conditions persist consult a doctor

  • If you are pregnant or have liver disease, don't take this product unless directed by a doctor.

Directions



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. Do not exceed 1 gram (1000 mg).

WeightDosage (Taken as a single dose)
READ INSERT CAREFULLY BEFORE USE
25-37 lb2 tablet
38-62 lbs4 tablets
63-87 lbs6 tablets
88-112 lbs8 tablets
113-137 lbs10 tablets
138-162 lbs12 tablets
163-187 lbs14 tablets
over 188 lbs16 tablets

Take only according to directions and don't exceed recommended dosage unless directed by a doctor. Medication should only be taken one time as a single dose; do not repeat treatment unless directed by a doctor. When one individual in house hold 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 doctor. If any symptoms or pinworms are still present after treatment consult a doctor

  • 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.

Otc - Keep Out Of Reach Of Children



Keep out of Reach of Children. In case of accidental overdose/ingestion contact a poison control center immediately.


Inactive Ingredients



Croscarmellose Sodium, Crospovidone, Dicalcium Phosphate, Magnesium Stearate, Microcrystalline Cellulose


Principal Display Panel - 20 Tablet Blister Pack Carton



VERMISOL
TABLET

Contains 20 Tablets


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