Label: TYLENOL EXTRA STRENGTH- acetaminophen tablet, film coated

  • NDC Code(s): 50580-937-01, 50580-937-02, 50580-937-03, 50580-937-04, view more
    50580-937-05, 50580-937-06, 50580-937-07, 50580-937-10, 50580-937-15, 50580-937-19, 50580-937-20
  • Packager: Johnson & Johnson Consumer Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 12, 2024

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

View All Sections
  • 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 1, corn starch 1, FD&C red no. 40 aluminum lake, hypromellose, magnesium stearate, modified starch 1, polyethylene glycol 1, powdered cellulose, pregelatinized starch, propylene glycol, shellac, sodium starch glycolate, titanium dioxide

    1
    contains one or more of these ingredients
  • Questions or comments?

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

  • PRINCIPAL DISPLAY PANEL

    NDC 50580-937-07

    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:50580-937
    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)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    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 (RED PRINT) Scoreno score
    ShapeOVALSize19mm
    FlavorImprint Code TYLENOL;500
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50580-937-0112 in 1 PACKAGE08/19/2019
    110 in 1 VIAL; Type 0: Not a Combination Product
    2NDC:50580-937-0212 in 1 PACKAGE09/16/2019
    210 in 1 VIAL; Type 0: Not a Combination Product
    3NDC:50580-937-032 in 1 POUCH; Type 0: Not a Combination Product07/31/202010/31/2022
    4NDC:50580-937-043 in 1 CARTON07/31/202011/08/2022
    42 in 1 POUCH; Type 0: Not a Combination Product
    5NDC:50580-937-0550 in 1 CARTON07/31/202010/31/2022
    52 in 1 POUCH; Type 0: Not a Combination Product
    6NDC:50580-937-2050 in 1 CARTON07/31/202010/31/2022
    62 in 1 POUCH; Type 0: Not a Combination Product
    7NDC:50580-937-061 in 1 CARTON08/31/2020
    724 in 1 BOTTLE; Type 0: Not a Combination Product
    8NDC:50580-937-101 in 1 CARTON08/31/2020
    850 in 1 BOTTLE; Type 0: Not a Combination Product
    9NDC:50580-937-071 in 1 CARTON08/31/2020
    9100 in 1 BOTTLE; Type 0: Not a Combination Product
    10NDC:50580-937-151 in 1 CARTON08/31/2020
    10225 in 1 BOTTLE; Type 0: Not a Combination Product
    11NDC:50580-937-19325 in 1 BOTTLE; Type 0: Not a Combination Product08/31/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01308/19/2019
    Labeler - Johnson & Johnson Consumer Inc. (878046358)
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!