Label: PAIN RELIEVER EXTRA STRENGTH- acetaminophen capsule, liquid filled 

  • 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 09/12

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

  • Active ingredient

    Acetaminophen 500 mg

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  • Purpose

    Pain reliever/ fever reducer

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  • Uses

    for the temporarily relief of minor aches and pains associated with: 

    • headache
    • minor arthritis pain 
    • muscular aches
    • backache
    • the common cold
    • pre- menstrual and menstrual cramps
    • toothache
    • 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 softgels 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

    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: 1-800-222-1222. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

    Do not exceed recommended dose

    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 professional before use.

    Keep out of reach of children.

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  • Directions

    • adults and children 12 years and over: take 2 softgels every 6 hours while symptoms last. Do not take more than 8 softgels in 24 hours
    • do not take for more than 10 days unless directed by a doctor
    • children under 12 years of age: do not use this adult product in children under 12 years of age. This will provide more than the recommended dose (overdose) and could cause serious health problems
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  • Other information

    • store at controlled room temperature 15°-30°C (59°-86°F)
    • do not use if imprinted safety seal under cap is broken or missing
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  • Inactive ingredients

    aerosil 200, D&C Yellow #10, edible ink, gelatin, glycerin USP, povidone K- 30 USP, polyethylene glycol 400 NF, polyethylene glycol 600 NF, propylene glycol USP, Purified water USP, sorbitol special GC, and titanium dioxide USP.

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  • Principal Display Panel

    Compare to Extra Strength TYLENOL® ACTIVE INGREDIENT*

    SEE NEW WARNINGS INFORMATION

    PAIN RELIEVER

    Extra Strength

    pain reliever & fever reducer

    ACETAMINOPHEN 500 mg

    Questions or comments ?

    call toll free 1-877-753-3935

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

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

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  • Product Label

    sunmark apap extra strength

    Extra strength Pain Reliever

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  • INGREDIENTS AND APPEARANCE
    PAIN RELIEVER  EXTRA STRENGTH
    acetaminophen capsule, liquid filled
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:49348-709
    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
    SILICON DIOXIDE  
    D&C YELLOW NO. 10  
    GELATIN  
    GLYCERIN  
    POVIDONES  
    POLYETHYLENE GLYCOL 400  
    POLYETHYLENE GLYCOL 600  
    PROPYLENE GLYCOL  
    WATER  
    SORBITOL  
    TITANIUM DIOXIDE  
    Product Characteristics
    Color YELLOW Score no score
    Shape CAPSULE Size 21mm
    Flavor Imprint Code APAP500
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:49348-709-59 1 in 1 CARTON
    1 40 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part343 07/09/2010
    Labeler - Mckesson (Sunmark) (177667227)
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