Label: TYLENOL EXTRA STRENGTH- acetaminophen tablet, film coated

  • NDC Code(s): 50580-491-01, 50580-491-10, 50580-491-70
  • Packager: Kenvue Brands LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 27, 2026

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  • Drug Facts

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient (in each caplet)

    Acetaminophen 500 mg

  • PURPOSE

    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

    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

    ■ 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)
    ■ do not use if blister unit is torn or broken

  • Inactive ingredients

    carnauba wax, FD&C red no. 40 aluminum lake, hypromellose, magnesium stearate, modified starch, polyethylene glycol, powdered cellulose, pregelatinized starch, propylene glycol, shellac, sodium starch glycolate, titanium dioxide.

  • Questions or comments?

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

  • PRINCIPAL DISPLAY PANEL

    NDC 50580-491-10

    To re-order reference the NDC Code

    TYLENOL ®
    FOR ADULTS

    Acetaminophen Pain Reliever - Fever Reducer

    Extra Strength

    FOR HOSPITAL USE ONLY. NOT FOR HOUSEHOLD USE. PACKAGE IS NOT CHILD-RESISTANT.

    100 Caplets
    500 mg each

    10 Blister Cards with 10 Individual Blisters

    tylenol-1

  • INGREDIENTS AND APPEARANCE
    TYLENOL EXTRA STRENGTH 
    acetaminophen tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-491
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
    SHELLAC (UNII: 46N107B71O)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    Product Characteristics
    Colorwhite (white with red print) Scoreno score
    ShapeOVALSize18mm
    FlavorImprint Code TYLENOL;500
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50580-491-701 in 1 CARTON08/30/2025
    1700 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:50580-491-011 in 1 CARTON08/30/2025
    2100 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:50580-491-1010 in 1 CARTON08/30/2025
    310 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01308/30/2025
    Labeler - Kenvue Brands LLC (118772437)
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