Label: ACETAMINOPHEN tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated June 12, 2024

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  • Drug Facts

    Active Ingredient (in each tablet)

    Acetaminophen 500 mg

    ASPIRIN FREE

    EXTRA STRENGTH PAIN RELIEVER

  • 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 
    •
    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 at room temperature

  • INACTIVE INGREDIENT

    Povidone, pregelatinized starch, sodium starch glycolate, stearic acid

  • Questions or comments?

    Call (800) 616-2471

  • SPL UNCLASSIFIED SECTION

    SAVE CARTON FOR COMPLETE DRUG FACTS

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

    Distributed By:

    Cardinal Health

    Dublin, OH 43017

    L5488143-10624

    L5488143-20624

    *This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol®

  • Principal Display Panel

    ACETAMINOPHEN

    EXTRA STRENGTH TABLETS

    500 mg

    10 TABLETS

    500mg bag label
  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55154-7897(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
    POVIDONE K30 (UNII: U725QWY32X)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeROUNDSize12mm
    FlavorImprint Code 54;27
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55154-7897-010 in 1 BAG09/12/2018
    11 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 - Cardinal Health 107, LLC (118546603)
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