Label: ACETAMINOPHEN tablet

  • NDC Code(s): 0904-6730-59, 0904-6730-60, 0904-6730-61, 0904-6730-80
  • Packager: Major Pharmaceuticals
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated May 8, 2024

If you are a consumer or patient please visit this version.

View All Sections
  • Drug Facts

    Active Ingredient (in each tablet)

    Acetaminophen 500 mg

  • PURPOSE

    Purpose

    Pain reliever/ Fever reducer

  • Uses

    Temporarily reduces fever and relieves minor aches and pains due to:

    • headache
    • muscular aches
    • backache
    • minor pain of arthritis
    • the common cold
    • toothache
    • premenstrual and menstrual cramps
  • WARNINGS

    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

    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.

    • 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

    Ask a doctor before use if you have liver disease

    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.

    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)

    adults and children 12 years and over:

    • take 2 tablets every 6 hours while symptoms last

    • do not take more than 6 tablets in 24 hours, unless directed by a doctor

    • do not take for more than 10 days unless directed by a doctor

    children under 12 years: ask a doctor

  • Other Information

    store in a dry place at 15° – 30°C (59° – 86°F).

  • INACTIVE INGREDIENT

    Povidone, pregelatinized starch, sodium starch glycolate, stearic acid

  • Questions or comments?

    Call 1-800-231-4670

  • SPL UNCLASSIFIED SECTION

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

    Distributed by:

    MAJOR® PHARMACEUTICALS
    Indianapolis, IN 46268

    *This product is not manufactured or distributed by Kenvue Inc., owner of the registered trademark Tylenol®.

  • PRINCIPAL DISPLAY PANEL

    MAJOR

    THIS LARGE SIZE PACKAGE FOR DISPENSING PURPOSE ONLY

    See New Warnings Information and Directions

    Acetaminophen Extra Strength Tablets

    Aspirin Free

    Extra Strenght Pain reliever

    Compare to active ingredient in Extra Strength Tylenol®* Tablets

    1000 tablets

    500mg each

    Major Label

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-6730
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeROUNDSize12mm
    FlavorImprint Code 54;27
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0904-6730-60100 in 1 BOTTLE; Type 0: Not a Combination Product09/12/2018
    2NDC:0904-6730-801000 in 1 BOTTLE; Type 0: Not a Combination Product09/12/2018
    3NDC:0904-6730-591 in 1 CARTON09/12/2018
    3100 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:0904-6730-6110 in 1 BOX, UNIT-DOSE09/12/2018
    410 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01309/12/2018
    Labeler - Major Pharmaceuticals (191427277)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!