Label: ACETAMINOPHEN- acetaminophen extra strength tablet

  • 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 July 5, 2021

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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
    • is a child with pain of arthritis

    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
    • 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:

    pregelatinized starch, microcrystalline cellulose, povidone (PVP K-30), colloidal silicon dioxide, croscarmellose sodium, 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

    * This product is not manufactured or distributed by McNeal Consumer Healthcare, Owner of registered trademark Tylenol.

  • PRINCIPAL DISPLAY PANEL

    500mg-100ct

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 
    acetaminophen extra strength tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71399-8027
    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
    ShapeROUNDSize12mm
    FlavorImprint Code APAP500
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71399-8027-1100 in 1 BOTTLE; Type 0: Not a Combination Product07/05/2021
    2NDC:71399-8027-21000 in 1 BOTTLE; Type 0: Not a Combination Product07/05/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34307/05/2021
    Labeler - Akron Pharma Inc. (067878881)
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