Label: ACETAMINOPHEN tablet

  • Category: HUMAN OTC DRUG LABEL

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 March 21, 2011

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  • *Compared to the active ingredient in Extra-Strength Tylenol® Tablets

    Drug Facts

  • ACTIVE INGREDIENT

    (in each tablet)

    Acetaminophen 500 mg

  • PURPOSES

    Pain Reliever/Fever Reducer

  • Keep Out of Reach of Children

    Keep out of reach of children

  • USES

    • temporarily relieves minor aches and pains
    • temporarily relieves reduces fever
  • WARNINGS

    Liver warning:

    This product contains acetaminophen. Severe liver damage may occur if you take

    • more than 8 tablets in 24 hours, which is the maximum daily amount
    • with other drugs containing acetaminophen
    • 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.

    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.

  • 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. 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 1-2 tablets every 4-6 hours, as needed. Do not take more than 8 tablets in 24 hours.
    Children under 12 yearsDo not use.
  • OTHER INFORMATION

    TAMPER EVIDENT: Do not use if imprinted seal under cap is missing or broken.

    • store at 20°-25°C (68°-77°F)
    • for institutional use only
  • INACTIVE INGREDIETNS:

    povidone, sodium starch glycolate, starch, stearic acid. May also contain: crospovidone, methylparaben and propylparaben

  • Distributor Information:

    *This product is not manufactured or distributed by the owner of the registered trademark TYLENOL®.

    Distributed by: GERI-CARE PHARMACEUTICALS CORP. 1650 63rd St., Brooklyn, New York 11204

    This Product was Repackaged By Sandhills Packaging For:

    Keltman Pharmaceuticals Inc.
    1 Lakeland Square, Suite A
    Flowood, MS 39232
    United States

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Label Image
  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68387-214(NDC:57896-201)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code M2A4;57344
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68387-214-3030 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34301/01/2011
    Labeler - Keltman Pharmaceuticals Inc. (362861077)
    Establishment
    NameAddressID/FEIBusiness Operations
    Keltman Pharmaceuticals Inc.362861077repack, relabel
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