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Pain Stoppers Regular (North Safety Products LLC)

Available Formats

Dosage Form Package Information Links
TABLET 250 CARTON in 1 CARTON (0498-2421-50) > 125 CARTON in 1 CARTON (0498-2421-25) > 50 PACKET in 1 CARTON (0498-2421-10) > 2 TABLET in 1 PACKET (0498-2421-01) Label Information

Complete Pain Stoppers Regular Information

  • Active ingredients (in each tablet)

    Acetaminophen 110mg

    Aspirin 162mg (NSAID)*

    Caffeine 32.4mg

    Salicylamide 152mg (NSAID)*

    *nonsteroidal anti-inflammatory drug


  • Purposes

    Pain reliever/fever reducer

    Pain reliever/fever reducer

    Diuretic

    Pain reliever/fever reducer


  • Uses

    for the temporary relief of minor aches and pains due to:

    common cold

    headache

    muscular aches

    premenstrual and menstrual cramps


  • 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 sign 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 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 12 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 severe 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 prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen or others)
    • have 3 or more alcoholic drinks every day while using this product
    • take more or for a longer time than directed

    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 are taking a diuretic
    • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease

    Stop using and ask a doctor if
    • symptoms do not improve
    • 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 pin 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 healthcare 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 pregnancy.


  • Keep out of reach of children.

    Overdose warning: 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 children even if you do not notice any signs or symptoms.


  • Directions

    • adults and children 12 years of age and over, take 2 tablets every 4 hours while symptoms persist
    • do not take more than 12 tablets in 24 hours
    • children under 12 years: consult a doctor


  • Other Information

    • store at a controlled room temperature 15 o-30 oC (59 o-86 oF)
    • TAMPER EVIDENT-DO NOT USE IF OPEN OR TORN

  • Inactive Ingredients

    FD&C Yellow #6, magnesium stearate, microcrystalline cellulose, povidone, starch, stearic acid,


  • Questions or comments?

    1-800-430-5490


  • Pain Stoppers regular

    Pain Stoppers


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    Pain stoppers 100CT


  • Pain Stoppers 250CT

    Pain Stoppers 250CT


  • Pain Stoppers 500CT

    Pain Stoppers 500CT


  • INGREDIENTS AND APPEARANCE
    PAIN STOPPERS 
    acetaminophen, caffeine, aspirin, salicylamide tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0498-2422
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 110 mg
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 162 mg
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE 32.4 mg
    SALICYLAMIDE (UNII: EM8BM710ZC) (SALICYLAMIDE - UNII:EM8BM710ZC) SALICYLAMIDE 152 mg
    Inactive Ingredients
    Ingredient Name Strength
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    POVIDONE K30 (UNII: U725QWY32X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    Product Characteristics
    Color orange (BRIGHT ORANGE) Score no score
    Shape ROUND Size 11mm
    Flavor Imprint Code FR;2
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0498-2422-50 500 in 1 BOX 01/02/2017
    1 NDC:0498-2422-01 2 in 1 PACKET; Type 0: Not a Combination Product
    2 NDC:0498-2422-25 250 in 1 BOX 01/02/2017
    2 NDC:0498-2422-01 2 in 1 PACKET; Type 0: Not a Combination Product
    3 NDC:0498-2422-10 100 in 1 BOX 01/02/2017
    3 NDC:0498-2422-01 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 REGULAR 
    acetaminophen, caffeine, aspirin, salicylamide tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0498-2421
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 110 mg
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 162 mg
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE 32.4 mg
    SALICYLAMIDE (UNII: EM8BM710ZC) (SALICYLAMIDE - UNII:EM8BM710ZC) SALICYLAMIDE 152 mg
    Inactive Ingredients
    Ingredient Name Strength
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    POVIDONE K30 (UNII: U725QWY32X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    Product Characteristics
    Color orange (BRIGHT ORANGE) Score no score
    Shape ROUND Size 11mm
    Flavor Imprint Code FR;2
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0498-2421-50 250 in 1 CARTON 04/18/2013 01/01/2017
    1 NDC:0498-2421-25 125 in 1 CARTON
    1 NDC:0498-2421-10 50 in 1 CARTON
    1 NDC:0498-2421-01 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 04/18/2013 01/01/2017
    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(0498-2421, 0498-2422)