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 50580-449-00, 50580-449-05, 50580-449-08, 50580-449-09, 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
Set ID 59773893-09a8-47a2-943a-e9ea9da4458a
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 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 wax1, corn starch1, FD&C red no. 40 aluminum lake, hypromellose, magnesium stearate, modified starch1, polyethylene glycol1, 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 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)
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