Label: ACETAMINOPHEN- 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 10, 2017

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

  • Active ingredient (in each tablet)

    Acetaminophen 500 mg

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  • Purposes

    Pain Reliever/Fever Reducer

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  • 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
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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.

    If pregnant or breast-feeding, 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

    • Store at room temperature
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  • Inactive ingredients

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

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  • Questions or comments?

    (800) 616-2471

    Tamper Evident:

    Do not use if sealed blister units are broken or damaged.

    Distributed By: MAJOR PHARMACEUTICALS

    31778 Enterprise Drive. Livonia, MI 48150 USA

    Rev. 02/12 M-95

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  • Principal Display Panel

    Acetaminophen Tabs 500mg bingo card label 

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  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 
    acetaminophen tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0615-4510(NDC:0904-1988)
    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)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    Color WHITE Score 2 pieces
    Shape ROUND (round flat faced beveled edge) Size 12mm
    Flavor Imprint Code GPI;A5
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0615-4510-39 30 in 1 BLISTER PACK; Type 0: Not a Combination Product 05/04/2011
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part343 05/04/2011
    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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