Label: ACETAMINOPHEN PAIN RELIEVER,FEVER REDUCER- acetaminophen 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 January 20, 2022

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  • Active ingredient (in each tablet)

    Acetaminophen 325 mg

  • Purposes

    Pain reliever/fever reducer

  • Warnings

    Liver warning: This product contains acetaminophen. Severe liver damage may occur if

    • adult takes more than 12 tablets in 24 hours, which is the maximum daily amount
    • 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 you are allergic to acetaminophen or any of the inactive ingredients in this product

    Ask a doctor before use if the user has

    liver disease.

    Ask a doctor or pharmacist before use if the user is

    taking the blood thinning drug warfarin.

    Stop use and ask a doctor if

    Pain gets worse or lasts more than 10 days in adults and children

    Pain gets worse or lasts more than 5 days in children under 12 years

    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.

  • Uses

    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.


  • Directions

    Do not take more than directed

    AGEDOSE
    Adults and Children 12 years and over
    • Take 2 tablets every 4 to 6 hours while symptoms last
    • Do not take more than 12 tablets in 24 hours
    Children 6 - 11 years
    • Take 1 tablet every 4 to 6 hours while symptoms last
    •  Do not take more than 5 tablets in 24 hours
    Children under 6 yearsDo not use adult Regular Strength products in children under 6 years of age; this will provide more than the recommended dose (overdose) of acetaminophen and may cause liver damage.

  • Other information


    • Do not use if imprinted Safety Seal under cap is broken or missing
    • Store at room temperature
  • Inactive ingredients

    Povidone, Pregelatinized Starch, Sodium Starch Glycolate, Stearic Acid.

  • Questions?

    If you have any questions or comments, or to report an adverse event, please contact (800) 795-9775.

  • Principal Display Panel

    PDP

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN  PAIN RELIEVER,FEVER REDUCER
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68071-4118(NDC:51645-703)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    Inactive Ingredients
    Ingredient NameStrength
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    Colorwhite (round) Scoreno score
    ShapeROUND (flat faced beveled edge) Size10mm
    FlavorImprint Code GPI;A325
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68071-4118-220 in 1 BOTTLE; Type 0: Not a Combination Product10/13/2017
    2NDC:68071-4118-525 in 1 BOTTLE; Type 0: Not a Combination Product10/13/2017
    3NDC:68071-4118-330 in 1 BOTTLE; Type 0: Not a Combination Product10/13/2017
    4NDC:68071-4118-440 in 1 BOTTLE; Type 0: Not a Combination Product10/13/2017
    5NDC:68071-4118-660 in 1 BOTTLE; Type 0: Not a Combination Product10/13/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34303/27/2006
    Labeler - NuCare Pharmaceuticals,Inc. (010632300)
    Establishment
    NameAddressID/FEIBusiness Operations
    NuCare Pharmaceuticals,Inc.010632300repack(68071-4118)
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