Label: TYLENOL EXTRA STRENGTH- acetaminophen tablet, film coated

  • NDC Code(s): 50580-457-10, 50580-457-11, 50580-457-70
  • Packager: Kenvue Brands LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 18, 2025

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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 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, corn starch, FD&C red no. 40 aluminum lake, hypromellose, magnesium stearate, 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

    500mg

    NDC 50580-457-11

    To re-order reference the NDC Code

    TYLENOL ®

    FOR ADULTS

    Acetaminophen Pain Reliever - Fever Reducer

    Extra Strength

    100 Caplets

    500 mg each

    10 Blister Cards

    with

    10 Individual Blisters

    SMART PACKAGING

    DESIGNED FOR HEALTH

    CARE PROFESSIONALS

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

    Tylenol-1

  • INGREDIENTS AND APPEARANCE
    TYLENOL EXTRA STRENGTH 
    acetaminophen tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-457
    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)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHELLAC (UNII: 46N107B71O)  
    SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colorwhite (WHITE WITH RED PRINT) Scoreno score
    ShapeOVALSize18mm
    FlavorImprint Code TYLENOL;500
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50580-457-1110 in 1 CARTON07/17/2020
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:50580-457-101 in 1 CARTON07/10/2020
    2100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    3NDC:50580-457-70700 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/17/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01307/10/2020
    Labeler - Kenvue Brands LLC (118772437)
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