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Pain Stoppers Extra (North Safety Products LLC)

Available Formats

Dosage Form Package Information Links
TABLET, COATED 250 CARTON in 1 CARTON (0498-2520-50) > 125 CARTON in 1 CARTON (0498-2520-25) > 50 PACKET in 1 CARTON (0498-2520-10) > 2 TABLET, COATED in 1 PACKET (0498-2520-01) Label Information

Complete Pain Stoppers Extra Information

  • Active Ingredients (in each tablet)

    Acetaminophen 250 mg

    Aspirin 250 mg

    Caffeine 65 mg


  • Purpose

    Pain reliever/Fever reducer


  • Uses

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


  • Warnings

    Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sigh of Reye's syndrome, a rare but serious illness.

    Allergy alert: Aspirin may cause a severe allergic reaction which may include:

    • hives
    • facial swelling
    • asthma (wheezing)
    • shock.

    Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

    • skin reddening
    • blisters
    • rash

    If a skin reaction occurs, stop use and seek medical help right away.

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

    • more than 16 tablets 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

    Stomach Bleeding Warning: This product contains an NSAID, 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 directed

    Caffeine 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

    • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
    • for more than 10 days for pain unless directed by a doctor
    • for more than 3 days for fever unless directed by a doctor

  • Ask a doctor before use if

    • stomach bleeding warning applies to you
    • you have a history of stomach problems, such as heartburn
    • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
    • you are taking a diuretic

  • Stop use and ask a doctor if

    • new symptoms occur
    • pain or fever persists or gets worse
    • you experience any of the following signs of stomach bleeding:
    • feel faint
    • vomit blood
    • have bloody or black stools
    • have stomach pain that does not get better
    • if ringing in the ears or a loss of hearing occurs, consult a doctor before taking any more of this product.

  • If Pregnant or breast feeding

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

    It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely 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

    Keep out of reach of children. In case of accidental 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.


  • Directions

    • 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


  • Other Information

    • store at a controlled room temperature 15 o-30 o C (59 o-86 o F)
    • do not use if package is opened or torn

  • Inactive Ingredients

    maltodextrin, microcrystaline cellulose, hypromellose, povidone, sodium

    starch glycolate, starch, stearic acid, titanium dioxide


  • Questions or Comments?

    1-800-430-5490


  • Pain Stoppers EX 500CT Label

    Pain stoppers Ex


  • Pain Stoppers EX 100CT

    Painstoppers EX 100Ct


  • Pain Soppers EX 250CT

    Pain Stoppers EX 250CT


  • Pain Stoppers Extra

    Pain Stoppers Extra


  • INGREDIENTS AND APPEARANCE
    PAIN STOPPERS EX 
    acetaminophen, caffeine, aspirin tablet, coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0498-2521
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 250 mg
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE 65 mg
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 250 mg
    Inactive Ingredients
    Ingredient Name Strength
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    POVIDONE K30 (UNII: U725QWY32X)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    Product Characteristics
    Color 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:0498-2521-10 100 in 1 BOX 01/02/2017
    1 NDC:0498-2521-01 2 in 1 PACKET; Type 0: Not a Combination Product
    2 NDC:0498-2521-25 250 in 1 BOX 01/02/2017
    2 NDC:0498-2521-01 2 in 1 PACKET; Type 0: Not a Combination Product
    3 NDC:0498-2521-50 500 in 1 BOX 01/02/2017
    3 NDC:0498-2521-01 2 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 01/02/2017
    PAIN STOPPERS EXTRA 
    acetaminophen, caffeine, aspirin tablet, coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0498-2520
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE 65 mg
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 250 mg
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 250 mg
    Inactive Ingredients
    Ingredient Name Strength
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    POVIDONE K30 (UNII: U725QWY32X)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    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 03/07/2012 01/01/2017
    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; Type 0: Not a Combination Product
    2 NDC:0498-2520-23 100 in 1 BOX 01/02/2017 01/03/2017
    2 NDC:0498-2520-02 2 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 03/07/2012 01/04/2017
    Labeler - Honeywell Safety Products USA, Inc (079287321)
    Registrant - Honeywell Safety Products USA, Inc (079287321)
    Establishment
    Name Address ID/FEI Business Operations
    Honeywell Safety Products USA, Inc 079287321 repack(0498-2520, 0498-2521)