Label: ACETAMINOPHEN- acetaminophen tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 11/12

If you are a consumer or patient please visit this version.

  • Active ingredient(s)

    Acetaminophen 500mg

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  • Purpose

    Pain Reliever/Fever Reducer

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  • Use(s)

    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.

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  • Warnings

    Liver Warning

    This product contains acetaminophen.

    The maximum daily dose of this product is 6 tablets (3,000mg) in 24 hours.  Severe liver damage may occur if you take

    • more than 4,000 mg of acetaminophen in 24 hours
    • 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. If you are allergic to acetaminophen or any of the inactive ingredients in this product.

    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.

    Pregnancy/Breastfeeding

    ask a health professionsl before use.

    Keep out of reach of children

    Overdose Warning: Taking more than the recommended dose ( overdose) may cause liver damage. In the 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.

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  • Directions

    Do not take more than the directed (see overdose warning)

    Adults and children 12 years and over:

    • Take 2 tablets every 6 hours while symptoms last.
    • Do not take more than 6 tablets in 24 hours unless directed by a doctor
    • Do not take for more than 10 days unless directed by a doctor

    Children under 12 years: Do not use adult Extra Strength product in children under 12 years of age; this will provide more than the recommended dose (overdose) of acetaminophen and may cause liver damage.

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  • Other information

    Do not use if imprinted safety seal under cap is broken or missing.

    Store at room temperature

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  • Inactive ingredients

    Povidone, Pregelantized Starch, Sodium Starch Glyculate, Stearic Acid.

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  • Questions

    To Report Adverse Drug Event call (800) 616-2471

    Dist. By MAJOR PHARMACEUTICALS

    31778 Enterprise Drive. Livonia, MI 48150

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  • Principal Display Panel

    Acetaminophen Tablets 500mg

    Acetaminophen Tablets 500mg

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  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 
    acetaminophen tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0615-4510(NDC:0904-1988)
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 500 mg
    Inactive Ingredients
    Ingredient Name Strength
    POVIDONE K12  
    STARCH, CORN  
    SODIUM STARCH GLYCOLATE TYPE A POTATO  
    12-HYDROXYSTEARIC ACID  
    Product Characteristics
    Color WHITE Score 2 pieces
    Shape ROUND Size 12mm
    Flavor Imprint Code GPI;A5
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0615-4510-31 31 in 1 BLISTER PACK
    2 NDC:0615-4510-39 30 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part343 10/04/2012
    Labeler - NCS HealthCare of KY, Inc dba Vangard Labs (050052943)
    Establishment
    Name Address ID/FEI Business Operations
    NCS HealthCare of KY, Inc dba Vangard Labs 050052943 RELABEL(0615-4510), REPACK(0615-4510)
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