Label: HEADACHE RELIEF EXTRA STRENGTH- acetaminophen, aspirin and caffeine tablet 

  • Label RSS
  • NDC Code(s): 49738-184-10, 49738-184-20, 49738-184-50
  • Packager: SMART SENSE (Kmart)
  • 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 12/12

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

  • Active ingredients (in each caplet)

    Acetaminophen 250 mg

    Aspirin 250 mg (NSAID)*

    Caffeine 65 mg

    *nonsteroidal anti-inflammatory drug

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  • Purposes

    Pain reliever

    Pain reliever

    Pain reliever aid

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  • Uses

    • temporarily relieves minor aches and pains due to:
      • headache
      • a cold
      • arthritis
      • muscular aches
      • sinusitis
      • toothache
      • premenstrual & 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

    Liver warning:

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

    • more than 8 caplets 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

    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, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, 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.

    Ask a doctor before use if

    • you have liver disease
    • 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
    • you have asthma

    Ask a doctor or pharmacist before use if you are

    taking

    • any other drug containing an NSAID (prescription or nonprescription)
    • a blood thinning (anticoagulant) or steroid drug
    • a prescription drug for diabetes, gout, or arthritis
    • any other drug, or are under a doctor’s care for any serious condition

    Stop use and ask doctor if

    • an allergic reaction occurs. Seek medical help right away.
    • 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
    • ringing in the ears or loss of hearing occurs
    • painful area is red or swollen
    • pain gets worse or lasts for more than 10 days
    • fever gets worse or lasts for more than 3 days
    • any new symptoms appear

    If pregnant or breast-feeding,

    ask a health 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.

    In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick 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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  • Directions

    • do not use more than directed
    • drink a full glass of water with each dose
    • adults and children 12 years and over: take 2 caplets every 6 hours; not more than 8 caplets in 24 hours
    • children under 12 years: ask a doctor
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  • Other information

    • store at controlled room temperature 20º-25ºC (68º-77ºF)
    • excursions permitted to 15ºC to 30ºC (59º-86ºF)
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  • Inactive ingredients

    hypromellose, maltodextrin, microcrystalline cellulose, polydextrose, polyvinylpyrrolidone, pregelatinized starch, silica, starch, stearic acid, talc, titanium dioxide, and triglycerides

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  • Questions or comments?

     Call toll free 1-800-842-7886

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  • Principal Display Panel

    Compare to the active ingredients of Excedrin® Extra Strength**

    EXTRA STRENGTH

    HEADACHE RELIEF

    Acetaminophen, Aspirin (NSAID)* and Caffeine

    Pain Reliever/Pain Reliever Aid

    GLUTEN FREE

    CAPLETS

    **This product is not manufactured or distributed by Novartis Consumer Health, owner of the registered trademark Excedrin® Extra Strength.

    Distributed by: Kmart Corporation

    Hoffman Estates, IL  60179

    Shop kmart.com

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

    DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

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  • Package Label

    Acetaminophen 250 mg, Aspirin 250 mg, Caffeine 65 mg

    Smart Sense Extra Strength Headache Relief Caplets

     

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  • INGREDIENTS AND APPEARANCE
    HEADACHE RELIEF  EXTRA STRENGTH
    acetaminophen, aspirin, caffeine tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:49738-184
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 250 mg
    ASPIRIN (ASPIRIN) ASPIRIN 250 mg
    CAFFEINE (CAFFEINE) CAFFEINE 65 mg
    Inactive Ingredients
    Ingredient Name Strength
    HYPROMELLOSES  
    MALTODEXTRIN  
    CELLULOSE, MICROCRYSTALLINE  
    POLYDEXTROSE  
    POVIDONE K15  
    STARCH, CORN  
    SILICON DIOXIDE  
    STARCH, CORN  
    STEARIC ACID  
    TALC  
    TITANIUM DIOXIDE  
    C10-18 TRIGLYCERIDES  
    Product Characteristics
    Color WHITE Score no score
    Shape CAPSULE Size 17mm
    Flavor Imprint Code 2793
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:49738-184-50 1 in 1 BOX
    1 50 in 1 BOTTLE
    2 NDC:49738-184-10 1 in 1 BOX
    2 100 in 1 BOTTLE
    3 NDC:49738-184-20 1 in 1 BOX
    3 200 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part343 06/19/2012
    Labeler - SMART SENSE (Kmart) (008965873)
    Registrant - P and L Development of New York Corporation (800014821)
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