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pain reliever (Mckesson (Sunmark))

Available Formats

Dosage Form Package Information Links
CAPSULE, LIQUID FILLED 1 BOTTLE, PLASTIC in 1 CARTON (49348-709-59) > 40 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC Label Information

Complete pain reliever Information

  • Active ingredient

    Acetaminophen 500 mg


  • Purpose

    Pain reliever/ fever reducer


  • 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

  • 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.

  • 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

  • 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

  • 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.


  • 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®


  • Product Label

    sunmark apap extra strength

    Extra strength Pain Reliever


  • INGREDIENTS AND APPEARANCE
    PAIN RELIEVER  EXTRA STRENGTH
    acetaminophen capsule, liquid filled
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:49348-709
    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
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POVIDONES (UNII: FZ989GH94E)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    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)