Label: BAYER ASPIRIN- aspirin tablet

  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 July 10, 2019

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

  • Drug Facts

  • Active ingredient (in each tablet)

    Aspirin 325 mg (NSAID)*

    *nonsteroidal anti-inflammatory drug


    Pain reliever/fever reducer

  • Uses

    temporarily relieves
    • headache • muscle pain • toothache

    • menstrual pain • pain and fever of colds • minor pain of arthritis

  • 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:
    • 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

    if you are allergic to aspirin or any other pain reliever/fever reducer

    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
    • redness or swelling is present
    • fever lasts more than 3 days
    • 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

    carnauba wax*,corn starch, hypromellose, powdered cellulose, triacetin

    *may contain this ingredient

  • Questions or comments?

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

  • Package Labeling:

    Package Label

    aspirin tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73097-003(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:73097-003-5025 in 1 CARTON07/03/2019
    12 in 1 POUCH; Type 0: Not a Combination Product
    2NDC:73097-003-1050 in 1 CARTON07/03/2019
    22 in 1 POUCH; Type 0: Not a Combination Product
    3NDC:73097-003-021 in 1 CARTON07/03/2019
    32 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34307/03/2019
    Labeler - Savings Distributors LLC (010527359)