Label: BAYER GENUINE ASPIRIN- aspirin tablet

  • DEA Schedule: None

Drug Label Information

Updated November 5, 2023

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  • Drug Facts

  • Active ingredients (in each tablet)

    Aspirin 325 mg (NSAID)*

    *nonsteroidal anti-inflammatory drug


    Pain reliever/fever reducer

  • Uses

    temporarily relieves minor aches and pains due to:

    • headache • muscle pain

    • toothache • menstrual pain

    • colds • minor pain of arthritis

    • temporarily reduces fever

  • Warnings

    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. Reye's syndrome: 

    Aspirin may cause a severe allergic reaction which may include: Allergy alert: 

    This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you Stomach bleeding warning: 

    • hives
    • facial swelling
    • asthma (wheezing)
    • shock
    • 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

    • if you are allergic to aspirin or any other pain reliever/fever reducer
    • if you have ever had an allergic reaction to this product or any of its ingredients

    Ask a doctor before use if

    • 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 a prescription drug for • gout • diabetes • 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 more than 10 days
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present
    • new symptoms occur
    • ringing in the ears or a loss of hearing occurs

    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.

  • Directions

    • drink a full glass of water with each dose
    • adults and children 12 years and over: take 1 or 2 tablets every 4 hours or 3 tablets every 6 hours, not to exceed 12 tablets in 24 hours
    • children under 12 years: consult a doctor

  • Other information

    • save carton for full directions and warnings
    • store at room temperature
  • Inactive ingredients

    corn starch, hypromellose, powdered cellulose, triacetin

  • Questions or comments?

    1-800-331-4536 (Mon – Fri 9AM – 5PM EST)

  • Package Labeling:

    Outer PackageInner Package

    aspirin tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50269-005(NDC:0280-2000)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Inactive Ingredients
    Ingredient NameStrength
    Product Characteristics
    ColorwhiteScoreno score
    FlavorImprint Code BAYER
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50269-005-066 in 1 BOX10/30/2019
    12 in 1 BLISTER PACK
    12 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01310/30/2019
    Labeler - JC World Bell Wholesale Co., Inc. (805257581)