NDC 0904-6719 Acetaminophen
Tablet Oral

Product Information

Acetaminophen is a human over the counter drug product labeled by Major Pharmaceuticals. The product's dosage form is tablet and is administered via oral form.

Product Code0904-6719
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.
Acetaminophen
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 - A solid dosage form containing medicinal substances with or without suitable diluents.
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.
Major Pharmaceuticals
Labeler Code0904
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.
10-18-2018
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 Acetaminophen?


Product Characteristics

Color(s)WHITE (C48325)
ShapeROUND (C48348)
Size(s)10 MM
Imprint(s)325MG;L403
Score1

Product Packages

NDC 0904-6719-50

Package Description: 1 BOTTLE in 1 CARTON > 50 TABLET in 1 BOTTLE

Price per Unit: $0.02468 per EA

NDC 0904-6719-60

Package Description: 100 TABLET in 1 BOTTLE

Price per Unit: $0.02468 per EA

NDC 0904-6719-80

Package Description: 1000 TABLET in 1 BOTTLE

Price per Unit: $0.02082 per EA

Product Details

What are Acetaminophen 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 325 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.

Acetaminophen 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:

Acetaminophen 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.

Patient Education

Acetaminophen

Acetaminophen is pronounced as (a set a mee' noe fen)

Why is acetaminophen medication prescribed?
Acetaminophen is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and reactions to va...
[Read More]

* Please review the disclaimer below.

Acetaminophen Labeling and Warnings

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.

Table of Contents



Active Ingredient (In Each Tablet)



Acetaminophen 325 mg


Purpose



Pain reliever/fever reducer


Uses



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

Warnings



Liver warning: This product contains acetaminophen. Severe liver damage may occur if

  • •adult takes more than 4,000 mg of acetaminophen in 24 hours
  • •child takes more than 5 doses in 24 hours
  • •taken with other drugs containing acetaminophen
  • •adult has 3 or more alcoholic drinks every day while using this product
  • Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

    • •skin reddening
    • •blisters
    • •rash
    • If a skin reaction occurs, stop use and seek medical help right away.


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 the user has ever had an allergic reaction to this product or any of its ingredients

Ask A Doctor Before Use If The User



  • •has liver disease
  • •is a child with pain of arthritis

Ask A Doctor Or Pharmacist Before Use If The User Is



taking the blood thinning drug warfarin


Stop Use And Ask A Doctor If



  • •pain gets worse or lasts more than 10 days (for adults) or 5 days (for children)
  • •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.


If Pregnant Or Breast-Feeding,



ask a health professional before use.


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)
  • take 2 tablets every 4 to 6 hours while symptoms last
  • do not take more than 10 tablets in 24 hours
  • do not use for more than 10 days unless directed by a doctortake 1 tablet every 4 to 6 hours while symptoms last
  • do not take more than 5 tablets in 24 hours
  • do not use for more than 5 days unless directed by a
  • doctor

    adults and children 12 years and over

    children

    6-11 years

     

    children under

    6 years

    ask a doctor


Inactive Ingredients



croscarmellose sodium*, povidone, pregelatinized starch, stearic acid

*may contain this ingredient


Questions Or Comments?



1-800-616-2471


Principal Display Panel



Compare to the active ingredient in Regular Strength Tylenol® Tablets

Acetaminophen

Pain Reliever/Fever Reducer

Aspirin-Free

Regular Strength

TABLETS

50 ACETAMINOPHEN TABLETS – 325 mg. EACH


* Please review the disclaimer below.