TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]

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  • TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]

TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]
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NDC 50580-692-01, 50580-692-02, 50580-692-03
Set ID dd87e342-b0cb-4111-9f15-415dbcda4b77
Category HUMAN OTC DRUG LABEL
Packager Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
Generic Name
Product Class
Product Number
Application Number PART343
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each tablet)

    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 tablets every 6 hours while symptoms last
    • do not take more than 6 tablets 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 neck band or foil inner seal imprinted with "TYLENOL" is broken or missing
  • Inactive ingredients

    carnauba wax, crospovidone, FD&C red no. 40 aluminum lake, FD&C yellow no. 6 aluminum lake, ferric oxide black, hypromellose, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, sucralose, titanium dioxide

  • Questions or comments?

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

  • PRINCIPAL DISPLAY PANEL

    NDC 50580-692-02

    Extra Strength
    TYLENOL®
    FOR ADULTS

    COATED
    TABLETS

    Acetaminophen
    Pain Reliever
    Fever Reducer

    Actual Size

    100 Tablets
    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:50580-692
    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)  
    CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    FD&C yellow no. 6 (UNII: H77VEI93A8)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    microcrystalline cellulose (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    polysorbate 80 (UNII: 6OZP39ZG8H)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    Sodium starch glycolate Type A potato (UNII: 5856J3G2A2)  
    stearic acid (UNII: 4ELV7Z65AP)  
    sucralose (UNII: 96K6UQ3ZD4)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorREDScoreno score
    ShapeROUNDSize12mm
    FlavorImprint Code TYLENOL;500
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50580-692-011 in 1 CARTON08/06/2018
    124 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:50580-692-021 in 1 CARTON08/06/2018
    2100 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:50580-692-031 in 1 CARTON08/06/2018
    3225 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34308/06/2018
    Labeler - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)
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