Label: PAIN STOPPERS EXTRA - caffeine, acetaminophen and aspirin tablet, coated

  • NDC Code(s): 0498-2520-01, 0498-2520-10, 0498-2520-25, 0498-2520-50
  • Packager: North Safety Products LLC
  • 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 04/13

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

  • ACTIVE INGREDIENT

    Active Ingredients (In Each Tablet)                        

    Acetaminophen 250 mg

    Aspirin 250 mg

    Caffeine 65 mg

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  • PURPOSE

    Enter section text here.

    Pain reliever/Fever reducer

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  • INDICATIONS & USAGE

    for the temporary relief of minor aches and pain with a headache


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  • DOSAGE & ADMINISTRATION

    Do not take more than directed

    the smallest effective dose should be used

    adults and children 12 years of age and over; take 2 tablets with a full glass of water every 4 hours

    do not take more than 16 tablets in 24 hours

    do not take longer than 10 days, unless directed by a doctor

    children under 12 years: ask a doctor


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  • WARNINGS

    Warnings: 

    Reye's syndrome: Children and teenagers should not use this 

    medicine for chicken pox or flu symptoms before a doctor is 

    consulted about Reye's syndrome, a rare but serious illness 

    reported to be associated with aspirin.

    Allergy Alert-Do not use:

    •    if you are allergic to aspirin or any other salicylate

    •    if you have ever had an allergic reaction to any other pain 

    reliever/fever reducer 

    Liver Warning: This product contains acetaminophen. Severe liver damage

         may occur if you take:

    •    more than 8 tablets in 24 hours

    •    with other drugs containing acetaminophen (prescription or nonprescription).  Ask a doctor or pharmacist before using with other drugs if you are not sure. 

    •    3 or more alcoholic drinks every day while using this product

    Stomach Bleeding Warning:This product contains nonsteroidal anti-inflammatory dugs (NSAIDs), which may cause stomach bleeding.  The chance is higher if you:

    •    are age 60 or older

    •    have had stomach ulcers or bleeding problems

    •    take a blood thinning (anticoagulant) or steroid drug

    •    take other drugs containing an NSAID (aspirin, ibuprofen, naproxen, or others.

    •    Take more or for a longer time than directedCaffeine warning: The recommended dose of this product contains about as much caffeine as a

    cup of coffee.

    When using this product:

    limit the use of caffeine containing medications, food or beverages, too much caffeine may cause nervousness,sleeplessness,irritability,occasionally, rapid heartbeat

    Do not use:

    If you ever had an allergic reaction to any other pain reliever/fever reducer

    •    with any other pain reliever/fever reducer

    •    for pain for more than 10 days or for fever for more than 3 

    days unless directed by a doctor

    •    with any other product containing acetaminophen  If you are not sure

    whether a drug contains acetaminophen, ask a doctor or pharmacist

    Ask doctor before using if you have:

    •    upset stomach or stomach pain

    •    ulcers

    •    bleeding problems

    •    high blood pressure

    •    heart or kidney disease

    •    taken a diuretic

    •    reached age 60 or older

          with any other drug containing an NSAID (prescription or nonprescription). Ask a doctor before using

    with other drugs if you are not sure

    •    taking a blood thinning (anticoagulant) or steroid drug

            When using this product do not exceed recommended dose

          Stop use and ask a doctor if:

    •    ringing in the ears or loss of hearing occurs

    •    pain or fever persists or gets worse

    •    new symptoms occur

    •    redness or swelling is present

    •    you feel faint, vomit blood, or have bloody or black stools.  These are signs of stomach bleeding

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  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding baby, ask a health professional  

    before use. IT IS ESPECIALLY IMPORTANT NOT TO USE ASPIRIN DURING THE LAST 3 MONTHS OF PREGNANCY UNLESS SPECIFICALLY DIRECTED TO DO SO BY A DOCTOR BECAUSE IT MAY CAUSE PROBLEMS IN THE UNBORN CHILD OR COMPLICATIONS DURING DELIVERY. KEEP OUT OF REACH OF CHILDREN.  

    In case of overdose, get medical help or contact a Poison Control  

    Center right away. Prompt 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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  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN. In case of overdose,  

    get medical help or contact a Poison Control Center right away.  

    Prompt 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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  • INACTIVE INGREDIENT

    Inactive Ingredients:  maltodextrin, microcrystaline cellulose, hypromellose, povidone, sodium

    starch glycolate, starch, stearic acid, titanium dioxide

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  • PRINCIPAL DISPLAY PANEL

    MM1

    NORTH Extra strength Pain 250 Carton

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  • INGREDIENTS AND APPEARANCE
    PAIN STOPPERS EXTRA 
    acetaminophen, caffeine, aspirin tablet, coated
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0498-2520
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CAFFEINE (CAFFEINE) CAFFEINE 65 mg
    ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 250 mg
    ASPIRIN (ASPIRIN) ASPIRIN 250 mg
    Inactive Ingredients
    Ingredient Name Strength
    STEARIC ACID  
    POVIDONE K30  
    STARCH, CORN  
    CELLULOSE, MICROCRYSTALLINE  
    SODIUM STARCH GLYCOLATE TYPE A POTATO  
    Product Characteristics
    Color white (SNOW WHITE) Score no score
    Shape ROUND Size 11mm
    Flavor Imprint Code FR;9
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0498-2520-50 250 in 1 CARTON
    1 NDC:0498-2520-25 125 in 1 CARTON
    1 NDC:0498-2520-10 50 in 1 CARTON
    1 NDC:0498-2520-01 2 in 1 PACKET
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 03/07/2012
    Labeler - North Safety Products LLC (019777263)
    Registrant - North Safety Products LLC (019777263)
    Establishment
    Name Address ID/FEI Business Operations
    ULTRAtab Laboratories, Inc. 151051757 manufacture(0498-2520)
    Establishment
    Name Address ID/FEI Business Operations
    Ultra Seal Corporation 085752004 repack(0498-2520)
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