PAIN STOPPERS EX (ACETAMINOPHEN, CAFFEINE, ASPIRIN) TABLET, COATED PAIN STOPPERS EXTRA (ACETAMINOPHEN, CAFFEINE, ASPIRIN) TABLET, COATED [HONEYWELL SAFETY PRODUCTS USA, INC]

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  • PAIN STOPPERS EX (ACETAMINOPHEN, CAFFEINE, ASPIRIN) TABLET, COATED PAIN STOPPERS EXTRA (ACETAMINOPHEN, CAFFEINE, ASPIRIN) TABLET, COATED [HONEYWELL SAFETY PRODUCTS USA, INC]

PAIN STOPPERS EX (ACETAMINOPHEN, CAFFEINE, ASPIRIN) TABLET, COATED PAIN STOPPERS EXTRA (ACETAMINOPHEN, CAFFEINE, ASPIRIN) TABLET, COATED [HONEYWELL SAFETY PRODUCTS USA, INC]
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NDC 0498-2520-01, 0498-2520-02, 0498-2520-10, 0498-2520-23, 0498-2520-25, 0498-2520-50, 0498-2521-01, 0498-2521-10, 0498-2521-25, 0498-2521-50
Set ID f1e4ccd8-1767-48fd-9049-560089029771
Category HUMAN OTC DRUG LABEL
Packager Honeywell Safety Products USA, Inc
Generic Name
Product Class
Product Number
Application Number PART343
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  • Active Ingredients (in each tablet)

    Acetaminophen 250 mg

    Aspirin 250 mg

    Caffeine 65 mg

  • Purpose

    Pain reliever/fever reducer

    Pain reliever/fever reducer

    Diuretic

  • 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 8 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 NSAIDs (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. Limit the use of caffeine-containing medications, food or beverages, while taking this product because too much caffeine may cause nervousness, sleeplessness, irritability, occasionally, rapid heartbeat

    Do not use

    • if you have ever had an allergic reaction to acetaminophen, aspirin or any other pain reliever/fever reducer
    • 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
    • you have asthma

    Ask a doctor or pharmacist before use if you are

    • taking a prescription drug for diabetes, gout or arthritis
    • taking any other drug or are under a doctor's care for any serious condition

    Stop use 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 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, 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.

    Overdose warning: In case of accidental overdose, get medical help or contact a Poison Control Center immediately. 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
    • drink a full glass of water with each dose
    • adults and children 12 years of age and older: take 2 tablets every 6 hours not more than 8 tablets in 24 hours
    • children under 12 yearsof age: consult a doctor

  • Other Information

    • store at room temperature 15 o-30 o C (59 o-86 o F)
    • TAMPER EVIDENT - DO NOT USE IF OPEN OR TORN
  • Inactive Ingredients

    hypromellose, maltodextrin, microcrystaline cellulose, povidone, sodium starch glycolate, starch, stearic acid, titanium dioxide

  • Questions or Comments?

    1-800-430-5490

  • Pain Stoppers EX 100CT

    Painstoppers EX 100Ct

  • Pain Soppers EX 250CT

    Pain Stoppers EX 250CT

  • PainStoppers EX 500ct

    Pain Stoppers Extra

  • Pain Stoppers Extra

    pain Stoppers Extra

  • INGREDIENTS AND APPEARANCE
    PAIN STOPPERS EX 
    acetaminophen, caffeine, aspirin tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-2521
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN250 mg
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE65 mg
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN250 mg
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColorwhiteScoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code FR;9
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-2521-10100 in 1 BOX01/02/2017
    1NDC:0498-2521-012 in 1 PACKET; Type 0: Not a Combination Product
    2NDC:0498-2521-25250 in 1 BOX01/02/2017
    2NDC:0498-2521-012 in 1 PACKET; Type 0: Not a Combination Product
    3NDC:0498-2521-50500 in 1 BOX01/02/2017
    3NDC:0498-2521-012 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34301/02/2017
    PAIN STOPPERS EXTRA 
    acetaminophen, caffeine, aspirin tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-2520
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE65 mg
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN250 mg
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN250 mg
    Inactive Ingredients
    Ingredient NameStrength
    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
    Colorwhite (SNOW WHITE) Scoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code FR;9
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-2520-50250 in 1 CARTON03/07/201201/01/2017
    1NDC:0498-2520-25125 in 1 CARTON
    1NDC:0498-2520-1050 in 1 CARTON
    1NDC:0498-2520-012 in 1 PACKET; Type 0: Not a Combination Product
    2NDC:0498-2520-23100 in 1 BOX01/02/201701/03/2017
    2NDC:0498-2520-022 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34303/07/201201/04/2017
    Labeler - Honeywell Safety Products USA, Inc (079287321)
    Registrant - Honeywell Safety Products USA, Inc (079287321)
    Establishment
    NameAddressID/FEIBusiness Operations
    Honeywell Safety Products USA, Inc079287321repack(0498-2520, 0498-2521)
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