Label: TYLENOL ACETAMINOPHEN EXTRA STRENGTH- acetaminophen tablet, coated
TYLENOL ACETAMINOPHEN EXTRA STRENGTH- acetaminophen tablet, coated

  • NDC Code(s): 29485-1887-4, 29485-6547-4, 29485-6926-3, 29485-7003-2, view more
    29485-7025-2
  • Packager: Mechanical Servants, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated January 17, 2023

If you are a consumer or patient please visit this version.

View All Sections
  • 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 pouch is torn or damaged
  • Inactive ingredients

    carnauba wax 1, corn starch 1, FD&C red no. 40 aluminum lake, hypromellose, magnesium stearate, modified starch 1, polyethylene glycol 1, 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)

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    JOHNSON & JOHNSON CONSUMER INC.
    McNeil Consumer Healthcare Division
    Fort Washington, PA 19034 USA

    Repackaged and distributed by Convenience Valet ®, Melrose Park, IL 60160

  • PRINCIPAL DISPLAY PANEL - 500 mg Caplet Pouch Package

    TYLENOL 2TYLENOL®

    FOR ADULTS

    Acetaminophen

    Pain Reliever

    Fever Reducer

    Extra Strength

    2 Pouches of

    2 Caplets each

    500mg each

  • PRINCIPAL DISPLAY PANEL - 500 mg Caplet Pouch Package

    TYLENOL®

    FOR ADULTS
    Acetaminophen

    Pain Reliever

    Fever Reducer

    Extra Strength

    3 Pouches of
    2 Caplets each
    500 mg each

    Tylenol 03

  • PRINCIPAL DISPLAY PANEL - 500 mg Caplet Pouch Package

    TYLENOL ®

    FOR ADULTS

    Acetaminophen

    Pain Reliever

    Fever Reducer

    Extra Strength

    30 Pouches of

    2 Caplets each

    500 mg each

    Do not use if pouch is opened

    30 Pouches of 2 Caplets each - 500 mg each

    TYLENOL 30 BOX

  • PRINCIPAL DISPLAY PANEL - 500 mg Caplet Pouch Package

    TYLENOL ®

    FOR ADULTS

    Acetaminophen

    Pain Reliever

    Fever Reducer

    Extra Strength

    25 Pouches of

    2 Caplets each

    500 mg each

    Do not use if pouch is opened

    25 Pouches of 2 Caplets each - 500 mg each

    Tylenol 25

  • Tylenol ES CVP 4 Count Carton

    TYLENOL ®
    FOR ADULTS

    Acetaminophen
    Pain Reliever
    Fever Reducer

    EXTRA STRENGTH

    500 mg each

    4
    Caplets

    2 POUCHES OF 2 CAPLETS EACH

    CVP

    HEALTH

    Tylenol ES CVP 4ct

  • INGREDIENTS AND APPEARANCE
    TYLENOL ACETAMINOPHEN EXTRA STRENGTH 
    acetaminophen tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29485-6547
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
    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 TYLENOL;500
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:29485-6547-44 in 1 CARTON08/25/2017
    12 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34308/25/2017
    TYLENOL ACETAMINOPHEN EXTRA STRENGTH 
    acetaminophen tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29485-7025
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHELLAC (UNII: 46N107B71O)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVALSize18mm
    FlavorImprint Code TYLENOL;500
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:29485-7025-225 in 1 BOX07/21/2020
    12 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34308/19/1984
    TYLENOL ACETAMINOPHEN EXTRA STRENGTH 
    acetaminophen tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29485-1887
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
    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 TYLENOL;500
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:29485-1887-42 in 1 PACKAGE08/19/1984
    12 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34308/19/1984
    TYLENOL ACETAMINOPHEN EXTRA STRENGTH 
    acetaminophen tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29485-7003
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHELLAC (UNII: 46N107B71O)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVALSize18mm
    FlavorImprint Code TYLENOL;500
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:29485-7003-230 in 1 BOX08/19/1984
    12 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34308/19/1984
    TYLENOL ACETAMINOPHEN EXTRA STRENGTH 
    acetaminophen tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29485-6926
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHELLAC (UNII: 46N107B71O)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVALSize18mm
    FlavorImprint Code TYLENOL;500
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:29485-6926-33 in 1 PACKAGE08/19/1984
    12 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34308/19/1984
    Labeler - Mechanical Servants, LLC (005530951)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!