Pyrantel Pamoate
Promex Llc
Human Otc Drug
NDC 58988-1760Pyrantel Pamoate is a human otc drug labeled by 'Promex Llc'. National Drug Code (NDC) number for Pyrantel Pamoate is 58988-1760. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Pyrantel Pamoate drug includes Pyrantel Pamoate - 180 mg/1 . The currest status of Pyrantel Pamoate drug is Active.
Drug Information:
| Drug NDC: | 58988-1760 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Pyrantel Pamoate |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Pyrantel Pamoate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Promex Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Tablet |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | PYRANTEL PAMOATE - 180 mg/1
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | ORAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | OTC MONOGRAPH FINAL |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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. |
| Marketing Start Date: | 27 Sep, 2002 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 22 Dec, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | part357B |
| 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. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | ProMex LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 199107
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | 81BK194Z5M
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 58988-1760-1 | 2 BLISTER PACK in 1 CARTON (58988-1760-1) / 10 TABLET in 1 BLISTER PACK | 27 Sep, 2002 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Purpose anthelmintic
Product Elements:
Pyrantel pamoate pyrantel pamoate pyrantel pamoate pyrantel croscarmellose sodium anhydrous dibasic calcium phosphate magnesium stearate microcrystalline cellulose
Indications and Usage:
Use for the treatment of pinworms.
Warnings:
Warnings 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.
Dosage and Administration:
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). weight dosage (taken as a single dose) read insert carefully before use 25-37 lb 2 tablet 38-62 lbs 4 tablets 63-87 lbs 6 tablets 88-112 lbs 8 tablets 113-137 lbs 10 tablets 138-162 lbs 12 tablets 163-187 lbs 14 tablets over 188 lbs 16 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 do
Read more...ctor 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.
Package Label Principal Display Panel:
Principal display panel - 20 tablet blister pack carton vermisol tablet contains 20 tablets principal display panel - 20 tablet blister pack carton