Label: ACETAMINOPHEN tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 December 16, 2009

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  • *Compared to the active ingredient in Tylenol®

    Drug Facts

  • ACTIVE INGREDIENT

    (in each tablet)

    Acetaminophen 325 mg

  • PURPOSES

    Pain Reliever/Fever Reducer

  • 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.

  • 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

    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 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.

    Keep out of reach of children.

  • OVERDOSAGE

    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

    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

    • Store at room temperature 15°-30°C (59°-86°F)
    • Use by expiration date on package.
  • INACTIVE INGREDIETNS

    Povidone, Pregelatinized Starch, Sodium Starch Glycolate, Stearic Acid

    Questions? To report a Serious Adverse Event contact 1-877-835-5472.

    *This product is not manufactured or distributed by McNeil Consumer Products Co., owners of the registered trademark Tylenol®.

    Distributed by:

    Amneal Pharmaceuticals

    104 Hippocrates Way,

    Glasgow, KY 42141

    Rev. 11/2009


    Relabeling of "Additional Barcode Label" by:
    Physicians Total Care, Inc.
    Tulsa, OK       74146

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Acetaminophen Tablets

    325 mg

    Bottles of 50
    		NDC 54868-0548-2
    Bottles of 100
    		NDC 54868-0548-4
    Bottles of 1000
    		NDC 54868-0548-3
    image of 325 mg package label


  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54868-0548(NDC:65162-350)
    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 POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize4mm
    FlavorImprint Code GPI;A325
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54868-0548-250 in 1 BOTTLE
    2NDC:54868-0548-31000 in 1 BOTTLE
    3NDC:54868-0548-4100 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34310/24/2002
    Labeler - Physicians Total Care, Inc. (194123980)
    Establishment
    NameAddressID/FEIBusiness Operations
    Physicians Total Care, Inc.194123980relabel
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