TYLENOL EXTRA STRENGTH- acetaminophen tablet, coated

TYLENOL by

Drug Labeling and Warnings

TYLENOL by is a Otc medication manufactured, distributed, or labeled by Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

  • Questions or comments?

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

  • PRINCIPAL DISPLAY PANEL

    NDC: 50580-451-50

    See New Warnings Information & Directions

    TYLENOL®

    Pain Reliever
    Fever Reducer
    Acetaminophen

    EXTRA
    STRENGTH
    For Adults

    50 CAPLETS
    500 mg each

    Caplets

    For Hospital and Government Use Only

    Principal Display Panel
  • INGREDIENTS AND APPEARANCE
    TYLENOL   EXTRA STRENGTH
    acetaminophen tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 50580-451
    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)  
    castor oil (UNII: D5340Y2I9G)  
    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 Potato (UNII: 5856J3G2A2)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeOVALSize18mm
    FlavorImprint Code TYLENOL;500;HOSPITAL
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 50580-451-03150 in 1 CARTON08/19/199411/30/2016
    11 in 1 POUCH; Type 0: Not a Combination Product
    2NDC: 50580-451-1010 in 1 CARTON06/30/201401/31/2019
    210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC: 50580-451-501 in 1 CARTON08/19/1994
    350 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    4NDC: 50580-451-70700 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/19/1994
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34308/19/1994
    Labeler - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)

  • Trademark Results [TYLENOL]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    TYLENOL
    TYLENOL
    90512746 not registered Live/Pending
    Johnson & Johnson
    2021-02-05
    TYLENOL
    TYLENOL
    88182835 not registered Dead/Abandoned
    Johnson & Johnson
    2018-11-06
    TYLENOL
    TYLENOL
    85962420 4874809 Live/Registered
    Johnson & Johnson
    2013-06-18
    TYLENOL
    TYLENOL
    77564801 4096488 Live/Registered
    JOHNSON & JOHNSON
    2008-09-08
    TYLENOL
    TYLENOL
    77563361 not registered Dead/Abandoned
    Johnson & Johnson
    2008-09-05
    TYLENOL
    TYLENOL
    76072484 2660253 Live/Registered
    JOHNSON & JOHNSON
    2000-06-16
    TYLENOL
    TYLENOL
    73824422 1621973 Live/Registered
    JOHNSON & JOHNSON
    1989-09-11
    TYLENOL
    TYLENOL
    72326412 0890360 Live/Registered
    MCNEIL LABORATORIES, INCORPORATED
    1969-05-05

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