NDC 63941-104 Extra Strength Pain Relief
Acetaminophen Tablet, Coated Oral

Product Information

What is NDC 63941-104?

The NDC code 63941-104 is assigned by the FDA to the product Extra Strength Pain Relief which is a human over the counter drug product labeled by Valu Merchandisers Company. The generic name of Extra Strength Pain Relief is acetaminophen. The product's dosage form is tablet, coated and is administered via oral form. The product is distributed in 5 packages with assigned NDC codes 63941-104-01 1 bottle, plastic in 1 carton / 24 tablet, coated in 1 bottle, plastic, 63941-104-02 1 bottle, plastic in 1 carton / 50 tablet, coated in 1 bottle, plastic, 63941-104-04 1 bottle, plastic in 1 carton / 100 tablet, coated in 1 bottle, plastic, 63941-104-06 500 tablet, coated in 1 bottle, plastic , 63941-104-09 2 bottle, plastic in 1 carton / 100 tablet, coated in 1 bottle, plastic. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code63941-104
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.		Extra Strength Pain Relief
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.		Acetaminophen
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, Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is covered with a designated coating.
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.		Valu Merchandisers Company
Labeler Code63941
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.		part343
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 NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
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.		12-04-2009
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.		12-31-2023
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 Extra Strength Pain Relief?


Product Characteristics

Color(s)WHITE (C48325)
ShapeOVAL (C48345)
Size(s)17 MM
Imprint(s)M2A4;57344
Score1

Product Packages

NDC Code 63941-104-01

Package Description: 1 BOTTLE, PLASTIC in 1 CARTON / 24 TABLET, COATED in 1 BOTTLE, PLASTIC

NDC Code 63941-104-02

Package Description: 1 BOTTLE, PLASTIC in 1 CARTON / 50 TABLET, COATED in 1 BOTTLE, PLASTIC

NDC Code 63941-104-04

Package Description: 1 BOTTLE, PLASTIC in 1 CARTON / 100 TABLET, COATED in 1 BOTTLE, PLASTIC

NDC Code 63941-104-06

Package Description: 500 TABLET, COATED in 1 BOTTLE, PLASTIC

NDC Code 63941-104-09

Package Description: 2 BOTTLE, PLASTIC in 1 CARTON / 100 TABLET, COATED in 1 BOTTLE, PLASTIC

Product Details

What are Extra Strength Pain Relief 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.
  • ACETAMINOPHEN 500 mg/1 - Analgesic antipyretic derivative of acetanilide. It has weak anti-inflammatory properties and is used as a common analgesic, but may cause liver, blood cell, and kidney damage.

Extra Strength Pain Relief Active Ingredients UNII Codes

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:

Extra Strength Pain Relief Inactive Ingredients UNII Codes

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.

* Please review the disclaimer below.

Extra Strength Pain Relief Product Label

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.

Product Label Table of Contents



Other



Drug Facts


Active Ingredient (In Each Caplet)



Acetaminophen 500 mg


Purpose



Pain reliever/fever reducer


Uses



  • temporarily relieves minor aches and pains due to:
    • the common cold
    • headache
    • backache
    • minor pain of arthritis
    • toothache
    • muscular aches
    • premenstrual and menstrual cramps
    • temporarily reduces fever

Liver Warning



This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 4,000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Do Not Use



  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • if you are allergic to acetaminophen or any of the inactive ingredients in this product

Otc - Ask Doctor



Ask a doctor before use if you have liver disease.


Otc - Ask Doctor/Pharmacist



Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin


Stop Use And Ask A Doctor If



  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • redness or swelling is present

    • These could be signs of a serious condition.


Otc - Pregnancy Or Breast Feeding



If pregnant or breast-feeding, ask a health professional before use.


Otc - Keep Out Of Reach Of Children



Keep out of reach of children.


Overdose Warning



In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.


Directions



  • do not take more than directed (see overdose warning)
    • adults and children 12 years and over
    • take 2 caplets every 6 hours while symptoms last
    • do not take more than 6 caplets in 24 hours, unless directed by a doctor
    • do not use for more than 10 days unless directed by a doctor
    children under 12 years
    • ask a doctor

Other Information



  • store between 20-25°C (68-77°F)
  • retain carton for complete product information

Inactive Ingredients



hypromellose, mineral oil, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide


Principal Display Panel



COMPARE TO THE ACTIVE INGREDIENT IN TYLENOL® EXTRA STRENGTH CAPLETS†

Best Choice®

EXTRA STRENGTH

Pain Relief 

ACETAMINOPHEN

Pain Reliever/Fever Reducer

24 CAPLETS 500 mg EACH

image description - F100401BST R1

image description - F100401BST R1


* Please review the disclaimer below.