Label: ASPIRIN- aspirin tablet

  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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 04/14

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

  • Active ingredient (in each tablet)

    Aspirin 81 mg (NSAID)*

    *nonsteroidal anti-inflammatory drug


    Low Dose

    Orange Flavor

    Aspirin Regimen**

    Gluten Free

  • Purpose

    Pain reliever

  • Uses

    for the temporary relief of minor aches and pains

  • 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:

    •facial swelling
    •asthma (wheezing)

    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

    **Aspirin is not appropriate for eveyone, so be sure to talk to you doctor before you begin and aspirin regimen.

    Do not use

    •if you have ever had an allergic reaction to any other pain reliever/fever reducer
    •for at least 7 days after tonsillectomy or oral surgery unless directed by a doctor

    Ask a doctor before use if

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

    Ask a doctor or pharmacist before use if you are

    taking a prescription drug for diabetes, gout or arthritis

    Stop use and ask a 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
    •pain gets worse or lasts for more than 10 days
    •fever gets worse or lasts for more than 3 days
    •redness or swelling is present
    •new symptoms occur
    •ringing in the ears or loss of hearing occurs

    These could be signs of a serious condition

    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.

    Warning: 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)

  • Directions

    •drink a full glass of water with each dose
    •adults and children 12 years and over: take 4 to 8 tablets every 4 hours not to exceed 48 tablets in 24 hours unless directed by a doctor
    •children under 12 years: consult a doctor
  • Other information

    •store at 20-25°C (68-77°F)

    COMPARE TO the active ingredient of BAYER® CHEWABLE ASPIRIN ***

    ***Major® Aspirin 81 mg is not manufactured or distributed by Bayer HealthCare LLC, distributor of Bayer Chewable A

    Gluten Free

    Bulk Manufacturer NDC 0904-4040-73

  • Inactive ingredients

    corn starch, dextrose excipient, FD&C yellow no. 6 aluminum lake, flavors, saccharin sodium

  • Questions or comments?


    Distributed by


    31778 Enterprise Drive

    Livonia, MI 48150 USA

    Rev. 11/11

    Repackaged by Cardinal Health

    Zanesville, OH 43701


  • Principal Display Panel


    Pain Reliever (NSAID) tablets

    81 mg

    Contains Approximately 2052 Tablets

    Bottle Label
    aspirin tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:55154-0748(NDC:0904-4040)
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Inactive Ingredients
    Ingredient Name Strength
    FD&C YELLOW NO. 6  
    Product Characteristics
    Color ORANGE Score no score
    Shape ROUND Size 8mm
    Flavor ORANGE Imprint Code L467
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55154-0748-8 2052 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Unapproved drug other 05/23/2011
    Labeler - Cardinal Health (188557102)
    Name Address ID/FEI Business Operations
    Cardinal Health 188557102 REPACK(55154-0748)