Label: EXAPRIN-AC- aspirin,caffeine tablet, film coated

  • NDC Code(s): 50332-0143-3, 50332-0143-4, 50332-0143-7, 50332-0143-8
  • 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 August 11, 2023

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

  • ACTIVE INGREDIENT

    Active ingredients (in each caplet)

    ​Aspirin (NSAID*) 500 mg *nonsteroidal anti-inflammatory drug

    Caffeine 32.5 mg

  • PURPOSE

    Purpose

    Pain reliever/fever reducer

    Pain reliever aid

  • INDICATIONS & USAGE

    Uses
    for the temporary relief of minor aches and pains due to
    ■ headache

    ■ muscular aches

    ■ backache pain

    ■ minor arthritis pain

    ■ 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 salicylates.

    Allergy alert:

    Magnesium salicylate may cause a severe allergic reaction which may include:

    ■ hives

    ■ facial swelling

    ■ asthma (wheezing)

    ■ shock

    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

  • DO NOT USE

    Do not use if you have ever had an allergic reaction to any pain reliever/fever reducer.

  • ASK DOCTOR

    Ask a doctor before use if

    ■ stomach bleeding warning applies to you

    ■ you have a history of stomach problems, such as heartburn

    ■ you have asthma, high blood pressure, heart disease, liver cirrhosis, or kidney disease

    ■ you are taking a diuretic

  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you take any drug for diabetes, gout or arthritis

  • STOP USE

    Stop use and ask a doctor if

    ■ an allergic reaction occurs, seek medical help right away

    ■ fever worsens or lasts more than 3 days

    ■ pain worsens or lasts more than 10 days

    ■ 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

    ■ ringing in the ears or loss of hearing occurs

    ■ new symptoms occur

    ■ redness or swelling is present

    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 at 20 weeks or later in 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. 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 2 caplets with a full glass of water every 6 hours while symptoms persist

    ■ do not take more than 8 caplets in 24 hours unless directed by a doctor

    Children under 12 years: ask a doctor

  • OTHER SAFETY INFORMATION

    Other information

    ■ caplets enclosed in a sealed packet

    ■ do not use if packet is torn, cut or open

    ■ store at 59° to 86°F (15°-30°C)

    ■ avoid excessive heat and humidity

  • INACTIVE INGREDIENT

    Inactive ingredients

    corn starch, hypromellose, maltodextrin, microcrystalline cellulose, polyethylene glycol, sodium lauryl sulfate

  • PRINCIPAL DISPLAY PANEL

    ExaprinAC.jpg

  • INGREDIENTS AND APPEARANCE
    EXAPRIN-AC 
    aspirin,caffeine tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50332-0143
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN500 mg
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE32.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeCAPSULE (Caplet) Size17mm
    FlavorImprint Code 44;413
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50332-0143-320 in 1 BAG01/09/2023
    12 in 1 PACKET; Type 0: Not a Combination Product
    2NDC:50332-0143-440 in 1 BOX01/09/2023
    22 in 1 PACKET; Type 0: Not a Combination Product
    3NDC:50332-0143-7100 in 1 BOX01/09/2023
    32 in 1 PACKET; Type 0: Not a Combination Product
    4NDC:50332-0143-8200 in 1 BOX01/09/2023
    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 finalpart34301/09/2023
    Labeler - HART Health (069560969)