Label: ACETAMINOPHEN tablet

  • NDC Code(s): 71399-8022-1, 71399-8022-2
  • Packager: Akron Pharma Inc.
  • 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 February 4, 2023

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  • Active ingredient (in each tablet)

    Acetaminophen 500 mg

  • Purpose

    Pain Reliever/Fever Reducer

  • Uses

    To reduce fever and for the temporary relief of minor aches and pains due to:

    •headache

    •muscular aches

    •backache

    •minor pain of arthritis

    •the common cold

    •toothache

    •premenstrual and menstrual cramps.

    •Temporarily reduces fever.

  • Warnings

    Liver warning:

    This product contains acetaminophen. Severe liver damage may occur if 

    • adult takes more than 4,000 mg of acetaminophen in 24 hours
    • child takes more than 5 doses in 24 hours 
    • taken with other drugs containing acetaminophen 
    • adult has 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 non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
    • if the user has ever had an allergic reaction to this product or any of its ingredients.

    Ask a doctor before use if the user has

    • has liver disease

    Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin

    Stop use and ask a doctor if:

    • pain gets worse or lasts more than 10 days (for adults) or 5 days (for children)
    • 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:

    Taking more than the recommended dose (overdose) may cause liver damage. 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 & children 12 years and over
    •  take 2 tablets every 6 hours while symptoms last
    • do not take more than 6 tablets in 24 hours, unless directed by a doctor
    • do not use for more than 10 days unless directed by a doctor
     child under 12 years ask a doctor

  • Other information

    • store at temperature 15° to 30°C (59° to 86°F)
  • Inactive Ingredients:

    croscannellose sodium, hydroxypropyl cellulose, colloidal silicon dioxide, microcrystalline cellulose, propyl paraben, povidone, stearic acid.

  • Questions or Comments?

    Call toll-free 1-877-225-6999

    Manufactured for
    Akron Pharma, Inc.,

    373 RT US46 W Building E,

    Suite 117, Fairfeld, NJ - 07004

    Mfg. Lic. No: TN/DRUGS/558/1997

    * This product is not manufactured or distributed by Johnson and Johnson, consumer inc., distributor of regular Tylenol Tablets.

  • PRINCIPAL DISPLAY PANEL

    500mg-100 Tablets

    500-100

    500mg-1000 Tablets

    500-1000

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71399-8022
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    POVIDONE (UNII: FZ989GH94E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeROUNDSize13mm
    FlavorImprint Code AP500
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71399-8022-1100 in 1 BOTTLE; Type 0: Not a Combination Product01/15/2021
    2NDC:71399-8022-21000 in 1 BOTTLE; Type 0: Not a Combination Product01/15/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34301/15/2021
    Labeler - Akron Pharma Inc. (067878881)
    Registrant - Akron Pharma Inc. (067878881)
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