Label: PAIN RELIEVER EXTRA STRENGTH- acetaminophen tablet

  • NDC Code(s): 46122-178-72, 46122-178-78
  • Packager: Amerisource Bergen
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 12/12

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

  • Active ingredient (in each tablet)

    Acetaminophen 500 mg

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  • Purpose

    Pain reliever/ fever reducer

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  • Uses

    • temporarily relieves minor aches and pains due to:
      • headache
      • the common cold
      • backache 
      • minor arthritis pain 
      • toothache
      • muscular aches
      • premenstrual and menstrual cramps
      • temporarily reduces fever
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  • 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 ever 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.

    Overdose warning: 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.

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  • Directions

    • do not take more than directed (see overdose warning)
    • adults and children 12 years and over:
      • take 2 tablets every 4 to 6 hours while symptoms last.
      • do not take more than 8 tablets in 24 hours
      • do not take for more than 10 days unless directed by a doctor
    • children under 12 years: do not use
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  • Other information

    • store at controlled room temperature 15°-30°C (59°-86°F)
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  • Inactive ingredients

    povidone, pregelatinized starch, sodium starch glycolate*, stearic acid

    *may contain this ingredient

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  • Questions or comments?

    Call 1-877-753-3935 Monday- Friday 9AM- 5PM EST

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  • Principal Display Panel

    Compare to TYLENOL® Extra Strength active ingredient †

    Extra Strength

    PAIN RELIEVER

    ACETAMINOPHEN 500 mg

    pain reliever/ fever reducer

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

    †This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Extra Strength Tylenol®

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  • Product Label

    Good Neighbor Pharmacy

    Acetaminophen 500 mg

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  • INGREDIENTS AND APPEARANCE
    PAIN RELIEVER  EXTRA STRENGTH
    acetaminophen tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:46122-178
    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
    POVIDONES  
    STARCH, CORN  
    SODIUM STARCH GLYCOLATE TYPE A CORN  
    STEARIC ACID  
    Product Characteristics
    Color WHITE Score no score
    Shape ROUND Size 12mm
    Flavor Imprint Code TCL252
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:46122-178-72 1 in 1 BOX
    1 60 in 1 BOTTLE
    2 NDC:46122-178-78 1 in 1 BOX
    2 100 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part343 11/08/2011
    Labeler - Amerisource Bergen (007914906)
    Registrant - P and L Development of New York Corporation (800014821)
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