NDC 53145-306 Parasitol

Pyrantel Pamoate

NDC Product Code 53145-306

NDC CODE: 53145-306

Proprietary Name: Parasitol 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.

Non-Proprietary Name: Pyrantel Pamoate 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.

Product Characteristics

Color(s):
YELLOW (C48330)
Shape: ROUND (C48348)
Size(s):
13 MM
Imprint(s):
G
Score: 1

NDC Code Structure

  • 53145 - Menper Distributors Inc.

NDC 53145-306-30

Package Description: 3 BLISTER PACK in 1 CARTON > 10 TABLET in 1 BLISTER PACK

NDC Product Information

Parasitol with NDC 53145-306 is a a human over the counter drug product labeled by Menper Distributors Inc.. The generic name of Parasitol is pyrantel pamoate. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Menper Distributors Inc.

Dosage Form: Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.

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.

Parasitol 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.

  • PYRANTEL PAMOATE 180 mg/1

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.

  • POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)
  • LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • CROSPOVIDONE (UNII: 2S7830E561)
  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • TALC (UNII: 7SEV7J4R1U)

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: Menper Distributors Inc.
Labeler Code: 53145
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: 01-02-2021 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 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Parasitol Product Label Images

Parasitol 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

Other

CAUTION: DO NOT USE IF BLISTER PACK IS BROKENDrug Facts

Distributed by MENPUR DISTRIBUTORS6500 N.W. 35th Ave., Miami, FL 33147www.menpurdistributors.com

Otc - Active Ingredient

Active ingredients (in each uncoated tablet)Pyrantel Pamoate USP 180 mg(equivalent to 62.5mg of pyrantel base)

Otc - Purpose

PurposeAntihelmintic

Indications & Usage

Use:for the treatment of pinworms

Warnings

Warnings: Do not exceed recommended dosage

Otc - Ask Doctor

  • Ask a doctor before use if: you're pregnantyou're nursing a babyhave liver disease

Otc - When Using

When using this product: abdominal cramps, nausea, vomiting, diarrhea, headache, or dizziness sometimes occur after taking this drug. If any of these symptoms persist, consult a doctor.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of overdose, get medical help or contact a poison control center right away.

Dosage & Administration

  • Directions: treat the entire familyWeightDosage (taken as a single dose)
  • Less than 25 lb. or under 2 yrs. oldDo not use unless directed by a doctor25-37 lb.2 tablets38-62 lb.4 tablets63-87 lb.6 tablets88-112 lb.8 tablets113-137 lb.10 tablets138-162 lb.12 tablets163-187 lb.14 tablets188 lb & over16 tablets

Storage And Handling

  • Other information:store at 15°-30°C (59°-86°F)

Inactive Ingredient

INACTIVE INGREDIENTS: Lactose Monohydrate, Microcrystalline Cellulose, Croscarmellose Sodium, Polyvinyl Pyrollidone, Potassium Sorbate, Polyethylene Glycol 6000, Crospovidone, Colloidal Anhydrous Silica, Magnesium Stearate, Purified Talc.

* Please review the disclaimer below.