Label: BAYER LOW DOSE- aspirin tablet

  • NDC Code(s): 0280-2100-12, 0280-2100-20, 0280-2100-30, 0280-2100-32, view more
    0280-2100-40
  • Packager: Bayer HealthCare LLC, Consumer Care
  • Category: HUMAN OTC DRUG LABEL

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 November 5, 2014

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient (in each tablet)

    Aspirin 81 mg (NSAID)*

    *nonsteroidal anti-inflammatory drug

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  • Purpose

    Pain reliever

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  • Uses

    • for the temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief.
    • ask your doctor about other uses for Bayer Safety Coated 81 mg Aspirin
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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 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 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
      • 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.

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  • 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
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  • Other information

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

    black iron oxide, brown iron oxide, carnauba wax, corn starch, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, methacrylic acid copolymer type C, polysorbate 80, powdered cellulose, propylene glycol, shellac, sodium lauryl sulfate, triacetin, triethyl citrate

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  • Questions or comments?

    1-800-331-4536 (Mon - Fri 9AM - 5PM EST) or www.bayeraspirin.com

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  • PRINCIPAL DISPLAY PANEL - 32 Tablet Bottle Carton

    N 0280-2100-32

    ASPIRIN REGIMEN

    BAYER
    ®

    ASPIRIN (NSAID) PAIN RELIEVER

    LOW DOSE

    81mg

    Safety Coated

    Aspirin

    32 ENTERIC COATED TABLETS

    Bayer Asprin Low Dose 81mg

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  • INGREDIENTS AND APPEARANCE
    BAYER   LOW DOSE
    aspirin tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0280-2100
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 81 mg
    Inactive Ingredients
    Ingredient Name Strength
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    BROWN IRON OXIDE (UNII: 1N032N7MFO)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHELLAC (UNII: 46N107B71O)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TRIACETIN (UNII: XHX3C3X673)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    Product Characteristics
    Color yellow Score no score
    Shape ROUND Size 5mm
    Flavor Imprint Code 81
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0280-2100-32 1 in 1 CARTON
    1 32 in 1 BOTTLE
    2 NDC:0280-2100-12 1 in 1 CARTON
    2 120 in 1 BOTTLE
    3 NDC:0280-2100-20 1 in 1 CARTON
    3 200 in 1 BOTTLE
    4 NDC:0280-2100-30 1 in 1 CARTON
    4 300 in 1 BOTTLE
    5 NDC:0280-2100-40 1 in 1 CARTON
    5 400 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part343 07/12/2002
    Labeler - Bayer HealthCare LLC, Consumer Care (785159372)
    Establishment
    Name Address ID/FEI Business Operations
    Bayer HealthCare LLC Consumer Care 072827066 manufacture(0280-2100) , pack(0280-2100)
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