Label: TYLENOL EXTRA STRENGTH- acetaminophen tablet, film coated

  • NDC Code(s): 50580-449-00, 50580-449-05, 50580-449-08, 50580-449-09, view more
    50580-449-10, 50580-449-11, 50580-449-12, 50580-449-13, 50580-449-14, 50580-449-15, 50580-449-23, 50580-449-31, 50580-449-34, 50580-449-35, 50580-449-36, 50580-449-61, 50580-449-62, 50580-449-84, 50580-449-85, 50580-449-86, 50580-449-87, 50580-449-96, 50580-449-97, 50580-449-98
  • Packager: Johnson & Johnson Consumer Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated March 23, 2023

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

  • 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 50580-449-96

    TYLENOL ®
    FOR ADULTS

    Acetaminophen
    Pain Reliever
    Fever Reducer

    Extra Strength
    Actual Size

    50 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:50580-449
    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
    ColorwhiteScoreno score
    ShapeOVALSize19mm
    FlavorImprint Code TYLENOL;500
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50580-449-001 in 1 CARTON08/19/1984
    1125 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:50580-449-051 in 1 CARTON08/19/1984
    224 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    3NDC:50580-449-082 in 1 POUCH; Type 0: Not a Combination Product08/19/1984
    4NDC:50580-449-091 in 1 CARTON08/19/1984
    4100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    5NDC:50580-449-1050 in 1 TRAY08/19/1984
    52 in 1 POUCH; Type 0: Not a Combination Product
    6NDC:50580-449-1150 in 1 TRAY08/19/1984
    62 in 1 POUCH; Type 0: Not a Combination Product
    7NDC:50580-449-133 in 1 CARTON08/19/1984
    72 in 1 POUCH; Type 0: Not a Combination Product
    8NDC:50580-449-142 in 1 POUCH; Type 0: Not a Combination Product08/19/1984
    9NDC:50580-449-1510 in 1 VIAL, PLASTIC; Type 0: Not a Combination Product08/19/1984
    10NDC:50580-449-231 in 1 CARTON08/19/1984
    10150 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    11NDC:50580-449-311 in 1 CARTON08/19/1984
    1136 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    12NDC:50580-449-34325 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/19/1984
    13NDC:50580-449-351 in 1 CARTON08/19/1984
    1324 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    14NDC:50580-449-361 in 1 CARTON08/19/1984
    14100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    15NDC:50580-449-611 in 1 CARTON08/19/1984
    15225 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    16NDC:50580-449-62325 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/19/1984
    17NDC:50580-449-842 in 1 POUCH; Type 0: Not a Combination Product08/19/1984
    18NDC:50580-449-8550 in 1 TRAY08/19/1984
    182 in 1 POUCH; Type 0: Not a Combination Product
    19NDC:50580-449-8650 in 1 TRAY08/19/1984
    192 in 1 POUCH; Type 0: Not a Combination Product
    20NDC:50580-449-873 in 1 CARTON08/19/1984
    202 in 1 POUCH; Type 0: Not a Combination Product
    21NDC:50580-449-1212 in 1 PACKAGE10/21/2014
    2110 in 1 VIAL, PLASTIC; Type 0: Not a Combination Product
    22NDC:50580-449-961 in 1 CARTON06/25/2018
    2250 in 1 BOTTLE; Type 0: Not a Combination Product
    23NDC:50580-449-97249 in 1 PACKAGE, COMBINATION; Type 0: Not a Combination Product01/28/2019
    24NDC:50580-449-98110 in 1 PACKAGE, COMBINATION; Type 0: Not a Combination Product01/28/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34308/19/1984
    Labeler - Johnson & Johnson Consumer Inc. (878046358)