Label: TYLENOL EXTRA STRENGTH- acetaminophen tablet, film coated

  • NDC Code(s): 50580-378-01, 50580-378-02, 50580-378-03, 50580-378-04, view more
    50580-378-05, 50580-378-06, 50580-378-07, 50580-378-08
  • Packager: Kenvue Brands LLC
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated November 7, 2024

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  • SPL UNCLASSIFIED SECTION

    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
  • 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.

    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

    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

    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 yearsask a doctor
  • Other information

    • store between 20-25°C (68-77°F)
    • do not use if carton is opened. Do not use if foil inner seal imprinted with "TYLENOL" is broken or missing
  • Inactive ingredients

    carnauba wax, crospovidone, FD&C red no. 40 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, sodium starch glycolate, stearic acid, titanium dioxide

  • Questions or comments?

    call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)

  • PRINCIPAL DISPLAY PANEL

    NDC 50580-378-06

    TYLENOL ®
    FOR ADULTS

    Acetaminophen
    Pain Reliever
    Fever Reducer

    Extra Strength

    Actual Size

    100 Caplets
    500 mg each

    PRINCIPAL DISPLAY PANEL
  • INGREDIENTS AND APPEARANCE
    TYLENOL EXTRA STRENGTH 
    acetaminophen tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-378
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHELLAC (UNII: 46N107B71O)  
    SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVALSize19mm
    FlavorImprint Code TYLENOL;500
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50580-378-011 in 1 CARTON11/01/2014
    124 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:50580-378-021 in 1 CARTON11/01/2014
    2100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    3NDC:50580-378-03225 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/06/2015
    4NDC:50580-378-041 in 1 CARTON03/01/2021
    424 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    5NDC:50580-378-051 in 1 CARTON03/01/2021
    550 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    6NDC:50580-378-061 in 1 CARTON03/01/2021
    6100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    7NDC:50580-378-071 in 1 CARTON03/01/2021
    7225 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    8NDC:50580-378-08325 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01311/01/2014
    Labeler - Kenvue Brands LLC (118772437)
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