Parasitol
Pyrantel Pamoate
Menper Distributors Inc.
Human Otc Drug
NDC 53145-101Parasitol also known as Pyrantel Pamoate is a human otc drug labeled by 'Menper Distributors Inc.'. National Drug Code (NDC) number for Parasitol is 53145-101. This drug is available in dosage form of Suspension. The names of the active, medicinal ingredients in Parasitol drug includes Pyrantel Pamoate - 144 mg/mL . The currest status of Parasitol drug is Active.
Drug Information:
| Drug NDC: | 53145-101 |
| 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: | Parasitol |
| 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: | Menper Distributors Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Suspension |
| 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 - 144 mg/mL
|
| 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: | 01 Jan, 2013 |
| 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: | Menper Distributors Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 199106
|
| 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 |
|---|
| 53145-101-11 | 1 BOTTLE in 1 BOX (53145-101-11) / 30 mL in 1 BOTTLE (53145-101-01) | 01 Jan, 2013 | 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 pinworm treatment
Product Elements:
Parasitol pyrantel pamoate pyrantel pamoate pyrantel acesulfame potassium anhydrous citric acid glycerin methylparaben polysorbate 80 potassium sorbate propylene glycol propylparaben sodium benzoate carboxymethylcellulose sodium sodium citrate sorbitol water xanthan gum
Indications and Usage:
Uses for the treatment of pinworms.
Warnings:
Warnings do not exceed recommended usage whenm using this product abdominal cramps, nausea, vomiting, diarrhea, headache, or dizziness sometimes occur after taking this drug. if any of these conditions persist consult a doctor. ask a doctor before use if you have liver disease
Dosage and Administration:
Directions read package insert carefully before taking this medication. take only according to directions and do not exceed the recommended dosage unless direct by a doctor. medication should only be taken one time as a single dose; do not repeat treatment unless direct by a doctor. 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 treatmen, consult a doctor. if any symptoms or pinworms are still present after treatment, consult a doctor. weight single dose less than 25 pounds or under 2 years of age do not use unless directed by a doctor 25 to 37 pounds 1/2 teaspoonful (2.5 ml) 38 to 62 pounds 1 teaspoonful (5 ml) 63 to 87 pounds 1 1/2 teaspoonfuls (7.5 ml) 88 to 112 pounds 2 teaspoonfuls (10 ml) 113 to 137 pounds 2 1/2 teaspoonfuls (12.5 ml) 138 to 162 pounds 3 teaspoonfuls (15 ml) 163 to 187 pounds 3 1/2 teaspoonfuls (17.5 ml) 188 pounds and over
Read more... 4 teaspoonfuls (20 ml) shake well before use. 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:
Parasitol_drug facts