TYLENOL EXTRA STRENGTH- acetaminophen tablet, film coated

Tylenol Extra Strength by

Drug Labeling and Warnings

Tylenol Extra Strength 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: 50580-937-01

    TYLENOL®
    FOR ADULTS

    Acetaminophen
    Pain Reliever
    Fever Reducer

    Extra Strength

    12 Vials of
    10 Caplets each
    500 mg each

    Use only as directed.

    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 potato (UNII: 5856J3G2A2)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITEScoreno 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
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34308/19/2019
    Labeler - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)

  • © 2021 FDA.report
    This site is not affiliated with or endorsed by the FDA.