Label: EXAPRIN- acetaminophen, aspirin, caffeine, 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

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 November 30, 2019

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)

  • PURPOSE

    Purpose:

    Pain Reliever / Fever Reducer

    Pain Reliever / Fever Reducer

    Pain Reliever Aid

    Pain Reliever / Fever Reducer

  • 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

  • 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: Acetaminophen and aspirin may cause severe allergic reactions which may include hives, skin reddening, blisters, rash, facial swelling, asthma (wheezing), or shock

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

    • more than 4,000 mg of acetaminophen in 24 hours
    • 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 had 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)

  • 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

  • ASK DOCTOR

    Ask a doctor before use if

    • stomach bleeding warning applies to you
    • 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
  • 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
  • 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
    • ringing in the ears or a loss of hearing occurs
    • you have any of the following signs of stomach bleeding: feel faint, vomit blood, or have bloody or black stools, or stomach pain that does not get better

    These could be signs of a serious condition

  • 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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

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

  • 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: ask a doctor

  • INACTIVE INGREDIENT

    Inactive Ingredients:

    FD&C Yellow #6, Magnesium Stearate, Microcrystalline Cellulose, Povidone, Starch, Stearic Acid

  • PRINCIPAL DISPLAY PANEL

    5631Exaprinv19f.jpg

  • INGREDIENTS AND APPEARANCE
    EXAPRIN 
    acetaminophen, aspirin, caffeine, salicylamide tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50332-0105
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN110 mg
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN162 mg
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE32.4 mg
    SALICYLAMIDE (UNII: EM8BM710ZC) (SALICYLAMIDE - UNII:EM8BM710ZC) SALICYLAMIDE152 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POVIDONE (UNII: FZ989GH94E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColororangeScoreno score
    ShapeROUNDSize12mm
    FlavorImprint Code EXA
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50332-0105-320 in 1 BOX, UNIT-DOSE01/20/1987
    12 in 1 PACKET; Type 0: Not a Combination Product
    2NDC:50332-0105-450 in 1 BOX, UNIT-DOSE01/20/1987
    22 in 1 PACKET; Type 0: Not a Combination Product
    3NDC:50332-0105-7125 in 1 BOX, UNIT-DOSE01/20/1987
    32 in 1 PACKET; Type 0: Not a Combination Product
    4NDC:50332-0105-8250 in 1 BOX, UNIT-DOSE01/20/1987
    42 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34301/20/1987
    Labeler - HART Health (069560969)