Label: PAIN STOPPERS- acetaminophen, caffeine, aspirin, salicylamide tablet
PAIN STOPPERS REGULAR- acetaminophen, caffeine, aspirin, salicylamide tablet

  • NDC Code(s): 0498-2421-01, 0498-2421-10, 0498-2421-25, 0498-2421-50, view more
    0498-2422-01, 0498-2422-10, 0498-2422-25, 0498-2422-50
  • Packager: North Safety Products LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 December 19, 2017

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

  • Active ingredients

    In each tablet:

    Acetaminophen 110mg

    Aspirin 162mg

    Caffeine 32.4mg

    Salicylamide 152mg

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  • Purpose

    Pain reliever, fever reducer

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  • Uses

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

    • common cold

    • headache

    • muscular aches

    • premenstrual and menstrual cramps

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  • 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
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  • 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
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  • 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
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  • 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.
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  • 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 children even if you do not notice any signs or symptoms.

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  • 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.

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  • 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: ask a doctor

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  • Other Information

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

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

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  • Questions or comments?

    1-800-430-5490

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  • Pain Stoppers regular

    MM1

    NORTH Regular Pain 100 carton

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  • Pain Stoppers 100CT
  • Pain Stoppers 250CT
  • 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 - North Safety Products LLC (019777263)
    Registrant - North Safety Products LLC (019777263)
    Establishment
    Name Address ID/FEI Business Operations
    North Safety Products LLC 019777263 repack(0498-2421, 0498-2422)
    Establishment
    Name Address ID/FEI Business Operations
    Ultra Seal Corporation 085752004 pack(0498-2421, 0498-2422)
    Establishment
    Name Address ID/FEI Business Operations
    ULTRAtab Laboratories, Inc. 151051757 manufacture(0498-2421, 0498-2422)
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