Label: ASPIRIN THIN COATED- aspirin tablet

  • Category: HUMAN OTC DRUG LABEL
  • 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 October 10, 2014

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

  • Active ingredient (in each tablet)

    Aspirin 325 mg (NSAID)*

    *nonsteroidal anti-inflammatory drug

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  • Purpose

    Pain reliever/fever reducer


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  • Uses

    temporary relieves:

    • minor pain of arthritis
    • headache
    • muscle pain
    • toothache
    • menstrual pain
    • pain and fever of colds
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  • 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 more or for a longer time than directed
    • take a blood thinning (anticoagulant) or steroid drug
    • take other drugs containing prescription and nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
    • have 3 or more alcoholic drinks every day while using this product


    Do not use

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


    Ask a doctor before use if

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

    Ask a doctor or pharmacist before use if you are

    taking a prescription drug for

    • gout
    • diabetes
    • arthiritis

    Stop use and ask a doctor if

    • 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
    • an allergic reaction occurs.  Seek medical help right away.
    • pain gets worse or lasts more than 10 days
    • redness or swelling is present
    • any new symptoms occur
    • fever gets worse or lasts more than 3 days
    • ringing in the ears or loss of hearing occurs

    If pregnant or breast-feeding,

    ask a health professional before use.  It is especially important not tuse 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 (-1800-222-1222) right away.

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  • Directions

    • drink a full glass of water with each dose
    • adults and children 12 years and over: take 1 to 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
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  • Other information

    • use by expiration date on package
    • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
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  • Inactive ingredients

    corn starch, hypromellose, polyetheylene glycol, propylene glycol

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  • Questions or comments?

    1-800-616-2471

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  • Principal display panel

    MAJOR PHARMACEUTICALS

    NDC 0904-2019-59

    Compare to the active ingredient in Genuine Bayer® Aspirin

    Aspirin
    325 mg

    Pain reliever/
    Fever reducer (NSAID)

    100 Tablets

    TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

    †This product is not manufactured or distributed by Bayer® HealthCare LLC, owner of the registered trademark Genuine Bayer® Aspirin.
    50844    ORG091315712

    Aspirin 325 mg tablets
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  • INGREDIENTS AND APPEARANCE
    ASPIRIN  THIN COATED
    aspirin tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0904-2019
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 325 mg
    Inactive Ingredients
    Ingredient Name Strength
    STARCH, CORN (UNII: O8232NY3SJ)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Product Characteristics
    Color WHITE Score no score
    Shape ROUND Size 11mm
    Flavor Imprint Code ASPIRIN;44157
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0904-2019-59 100 in 1 BOX
    1 100 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part343 05/07/2014
    Labeler - Major Pharmaceuticals (191427277)
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