Label: EXAPRIN- acetaminophen, aspirin, caffeine and salicylamide tablet

  • NDC Code(s): 50332-0105-3, 50332-0105-4, 50332-0105-7, 50332-0105-8
  • Packager: HART Health
  • 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 11/12

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

  • ACTIVE INGREDIENT

    Active Ingredients (in each tablet):

    Acetaminophen 110mg

    Aspirin (NSAID)* 162mg (*nonsteroidal anti-inflammatory drug)

    Caffeine 32.4mg

    Salicylamide (NSAID)* 152mg (*nonsteroidal anti-inflammatory drug)

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  • PURPOSE

    Purpose:

    Pain Reliever / Fever Reducer

    Pain Reliever / Fever Reducer

    Pain Reliever Aid

    Pain Reliever / Fever Reducer

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  • INDICATIONS & USAGE

    Uses:

    Temporarily relieves minor aches and pains due to

    • headache
    • backache
    • muscular aches
    • minor arthritis pain
    • the common cold
    • toothache
    • menstrual cramps

    Temporarily reduces fever

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  • WARNINGS

    Warnings:

    Reye's syndrome: Children and teenagers should not use this medicine for chicken pox or flu symptoms before a doctor is consulted about Reye's syndrome, a rare but serious illness reported to be associated with aspirin.

    Allergy alert: Aspirin may cause a severe allergic reaction which may include hives, facial swelling, asthma (wheezing), or shock

    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 products containing acetaminophen
    • 3 more 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 stomach ulcers or bleeding problems
    • take more or for a longer time than directed
    • take a blood thinning (anticoagulant) or steroid drug
    • have 3 or more alcohol drinks every day while using this product
    • take other drugs containing prescription or non-prescription NSAIDS (aspirin, ibuprofen, naproxen, others)

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  • DO NOT USE

    Do not use

    • with any other drug containing acetaminophen (prescription or non-prescription)
    • if you have ever had an allergic reaction to aspirin or any other pain reliever/fever reducer

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  • ASK DOCTOR

    Ask a doctor before use if

    • stomach bleeding warning applies to yo9u
    • you have asthma, high blood pressure, heart disease, liver cirrhosis, or kidney disease
    • you are taking a diuretic
    • you have a history of stomach problems, such as heartburn
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  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you

    • take any other drug containing an NSAID
    • take a blood thinning (anticoagulant) or steroid drug
    • take any drug for diabetes, gout, or arthritis
    • do not know if other drugs you are taking contain acetaminophen
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  • STOP USE

    Stop use and ask a doctor if

    • an allergic reaction occurs, seek medical help right away
    • new symptoms occur
    • fever worsens or lasts more than 3 days
    • pain worsens or lasts more than 10 days
    • redness or swelling is present in the painful area
    • ringing in the ears or loss of hearing occurs
    • you have any of the following signs of stomach bleeding: feel faint, vomit blood, have bloody or black stools, or stomach pain that does not get better

    These could be signs of a serious condition

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  • PREGNANCY OR BREAST FEEDING

    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 is may cause problems in the unborn child or complications during delivery

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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

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  • OVERDOSAGE

    Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. In cas eof overdose, get medical help or contact a Poison Control Center right away. 1-800-222-1222

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  • DOSAGE & ADMINISTRATION

    Directions: do not take more than directed.

    Adults and children 12 years of age and over:

    • take 1 or 2 tablets with water every 4 hours while sympotms persist
    • do not take more than 8 tablets in 24 hours unless directed by a doctor

    Children under 12 years of age: do not use; this will provide more than the recommended dose (overdose) and my cause liver damage

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  • INACTIVE INGREDIENT

    Inactive Ingredients: Corn Starch, FD&C Yellow #6 Lake, Magnesium Stearate, Microcrystalline Cellulose, Povidone, Stearic Acid

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  • INGREDIENTS AND APPEARANCE
    EXAPRIN 
    acetaminophen, aspirin, caffeine, salicylamide tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:50332-0105
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 110 mg
    ASPIRIN (ASPIRIN) ASPIRIN 162 mg
    CAFFEINE (CAFFEINE) CAFFEINE 32.4 mg
    SALICYLAMIDE (SALICYLAMIDE) SALICYLAMIDE 152 mg
    Inactive Ingredients
    Ingredient Name Strength
    STARCH, CORN  
    FD&C YELLOW NO. 6  
    MAGNESIUM STEARATE  
    CELLULOSE, MICROCRYSTALLINE  
    POVIDONE  
    STEARIC ACID  
    Product Characteristics
    Color orange Score no score
    Shape ROUND Size 12mm
    Flavor Imprint Code EXA
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50332-0105-3 20 in 1 BOX, UNIT-DOSE
    1 2 in 1 PACKET
    2 NDC:50332-0105-4 50 in 1 BOX, UNIT-DOSE
    2 2 in 1 PACKET
    3 NDC:50332-0105-7 125 in 1 BOX, UNIT-DOSE
    3 2 in 1 PACKET
    4 NDC:50332-0105-8 250 in 1 BOX, UNIT-DOSE
    4 2 in 1 PACKET
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 01/20/1987
    Labeler - HART Health (069560969)
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