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: 50580-449-96

    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 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: 50580-449-001 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
    5NDC: 50580-449-082 in 1 POUCH; Type 0: Not a Combination Product
    6NDC: 50580-449-1150 in 1 TRAY08/19/1984
    6NDC: 50580-449-082 in 1 POUCH; Type 0: Not a Combination Product
    7NDC: 50580-449-133 in 1 CARTON08/19/1984
    7NDC: 50580-449-082 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
    18NDC: 50580-449-842 in 1 POUCH; Type 0: Not a Combination Product
    19NDC: 50580-449-8650 in 1 TRAY08/19/1984
    19NDC: 50580-449-842 in 1 POUCH; Type 0: Not a Combination Product
    20NDC: 50580-449-873 in 1 CARTON08/19/1984
    20NDC: 50580-449-842 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., McNeil Consumer Healthcare Division (878046358)

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