NDC 72189-120 Pluspharma Extra Strength Pain Reliever, Fever Reducer 500 Mg

Acetaminophen

NDC Product Code 72189-120

NDC CODE: 72189-120

Proprietary Name: Pluspharma Extra Strength Pain Reliever, Fever Reducer 500 Mg 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: Acetaminophen 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This drug is used to treat mild to moderate pain (from headaches, menstrual periods, toothaches, backaches, osteoarthritis, or cold/flu aches and pains) and to reduce fever.

Product Characteristics

Color(s):
WHITE (C48325)
Shape: ROUND (C48348)
Size(s):
12 MM
Imprint(s):
GPI;A5
Score: 2

NDC Code Structure

  • 72189 - Direct Rx
    • 72189-120 - Pluspharma Extra Strength Pain Reliever, Fever Reducer 500 Mg

NDC 72189-120-50

Package Description: 50 TABLET in 1 BOTTLE

NDC Product Information

Pluspharma Extra Strength Pain Reliever, Fever Reducer 500 Mg with NDC 72189-120 is a a human over the counter drug product labeled by Direct Rx. The generic name of Pluspharma Extra Strength Pain Reliever, Fever Reducer 500 Mg is acetaminophen. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Direct Rx

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.

Pluspharma Extra Strength Pain Reliever, Fever Reducer 500 Mg 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.

  • ACETAMINOPHEN 500 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.

  • POVIDONE (UNII: FZ989GH94E)
  • SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • STARCH, CORN (UNII: O8232NY3SJ)

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.
  • 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: Direct Rx
Labeler Code: 72189
FDA Application Number: part343 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 NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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: 07-14-2020 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: 12-31-2021 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.

Pluspharma Extra Strength Pain Reliever, Fever Reducer 500 Mg Product Label Images

Pluspharma Extra Strength Pain Reliever, Fever Reducer 500 Mg 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

Spl Medguide

PlusPHARMASee New Warnings Information and DirectionsExtra StrengthACETAMINOPHEN 500 mgPAIN RELIEVER FEVER REDUCERCONTAINS NO ASPIRINCompare to the Active Ingredient in Extra Strength Tylenol®This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Extra Strength Tylenol®

Spl Patient Package Insert

If you have any questions or comments, or to report an adverse event, please contact (800) 795-9775.

Inactive Ingredient

Povidone, Pregelatinized Starch, Sodium Starch Glycolate, Stearic Acid.

Other Safety Information

Do not use if imprinted safety seal under cap is broken or missing

Store at room temperature

* Please review the disclaimer below.