Label: ACETAMINOPHEN EXTRA STRENGTH- acetaminophen tablet, film coated

  • 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 07/11

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

  • ACTIVE INGREDIENT

    Active Ingredient (in each tablets

    acetaminophen 500 mg

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  • INACTIVE INGREDIENT


    Inactive ingredients: hypromellose, mineral oil, povidone, pregelatinized starch, stearic acid, titanium dioxide

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  • PURPOSE

    PAIN RELIEVER - FEVER REDUCER

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  • WARNINGS

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

        more than 8 caplets 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

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  • INDICATIONS & USAGE

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

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  • ASK DOCTOR

    Ask a doctor before use if you have liver disease.

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  • STOP USE

    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.

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  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

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  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

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  • DOSAGE & ADMINISTRATION

    Directions:  Do not take more than directed (see overdose warning)

    adults and children 12 years and over:  take 2 caplets every 4 to 6 hours while symptoms last

    do not take more than 8 caplets in 24 hours

    do not take for more than 10 days unless directed by a doctor


    children under 12 years:  do not use this adult extra strength product in children under 12 years of age; this will provide more than the recommended does (overdose) of acetaminophen any may cause lier damage.


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  • PRINCIPAL DISPLAY PANEL

    100labelEnter section text here

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  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN   EXTRA STRENGTH
    acetaminophen tablet, film coated
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:49483-341
    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
    HYPROMELLOSES  
    MINERAL OIL  
    POVIDONE  
    STARCH, CORN  
    STEARIC ACID  
    TITANIUM DIOXIDE  
    Product Characteristics
    Color white Score no score
    Shape OVAL Size 17mm
    Flavor Imprint Code TCL341
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:49483-341-01 100 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 07/18/2011
    Labeler - TIME CAP LABS INC (037052099)
    Establishment
    Name Address ID/FEI Business Operations
    TIME CAP LABS INC 037052099 manufacture
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