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ACETAMINOPHEN (Keltman Pharmaceuticals Inc.)

Available Formats

Dosage Form Package Information Links
TABLET 30 TABLET in 1 BOTTLE, PLASTIC (68387-214-30) Label Information

Complete ACETAMINOPHEN Information

  • SPL UNCLASSIFIED SECTION

    *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

    Age Dose
    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 years Do 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 Type HUMAN OTC DRUG Item Code (Source) NDC:68387-214(NDC:57896-201)
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg
    Inactive Ingredients
    Ingredient Name Strength
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    Color WHITE Score no score
    Shape ROUND Size 11mm
    Flavor Imprint Code M2A4;57344
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68387-214-30 30 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part343 01/01/2011
    Labeler - Keltman Pharmaceuticals Inc. (362861077)
    Establishment
    Name Address ID/FEI Business Operations
    Keltman Pharmaceuticals Inc. 362861077 repack, relabel