Label: TYLENOL EXTRA STRENGTH CAPLET- acetaminophen tablet

  • NDC Code(s): 67414-449-00, 67414-449-10, 67414-449-11
  • Packager: Jones Healthcare Group - Packaging Services, Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 6, 2023

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  • 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 menstual cramps • temporarily reduces lever

  • Warnings

    This product contains acetaminophen. Severe liver damage may occur if you take • more than 4,000 mg of acetaminophen in 24 hours  Liver warning: 

    • 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 warnings:

    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

    • do not take more than directed (see overdose warning). 
     Adults and children 12 years and over:
    • take 2 capletes every 6 hours while symptoms last
    • do not take more than 6 capletes in 24 hours, unless directed by a doctor
    • do not use for more than 10 days unless directed by a doctor
     children under 12 years ask a doctor

  • Other information

    • store between 20-25C (68-77F) 
    • do not use if pouch is torn or damaged. 
  • Inactive ingredients

    carnauba wax*, corn starch*, FD&C red no.40 aluminum lake, hypromellose, magnesium stearate, modified starch*,  polyethylene glycol*, powdered cellulose, pregelatinized starch, propylene glycol, shellac, sodium starch glycolate, titanium dioxide * contains one or more of these ingredients

  • Questions or comments?

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

  • Package Labeling:

    PouchLabel

  • INGREDIENTS AND APPEARANCE
    TYLENOL EXTRA STRENGTH   CAPLET
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67414-449
    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)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVALSize18mm
    FlavorImprint Code TYLENOL500
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67414-449-002500 in 1 BOX01/24/2018
    12 in 1 POUCH; Type 0: Not a Combination Product
    2NDC:67414-449-1050 in 1 BOX01/24/2018
    22 in 1 POUCH; Type 0: Not a Combination Product
    3NDC:67414-449-1150 in 1 BOX01/24/2018
    32 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01301/24/2018
    Labeler - Jones Healthcare Group - Packaging Services, Inc (243261024)
    Registrant - Jones Healthcare Group - Packaging Services, Inc (243261024)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dr. Reddy's Laboratories Louisiana, LLC830397282manufacture(67414-449)
    Establishment
    NameAddressID/FEIBusiness Operations
    McNeil Healthcare LLC.831188763manufacture(67414-449)
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