Label: BAYER WOMENS- aspirin tablet, coated

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 December 18, 2017

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

  • Drug Facts
  • Active ingredients

    *
    nonsteroidal anti-inflammatory drug
    Active ingredients (in each caplet) Purposes
    Aspirin 81 mg (NSAID) * Pain reliever
    Calcium carbonate 777 mg

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  • Purposes
  • Uses

    • for the temporary relief of minor aches and pains or as recommended by your doctor.
    • ask your doctor about other uses for Bayer Women’s 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
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  • 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
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  • 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
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  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are taking a prescription

    drug for

    • gout
    • diabetes
    • arthritis
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  • STOP USE

    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
    • new symptoms occur
    • ringing in the ears or a loss of hearing occurs
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  • PREGNANCY OR BREAST FEEDING

    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.

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  • KEEP OUT OF REACH OF CHILDREN

    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

    • talk to your doctor about regimen use of aspirin
    • drink a full glass of water with each dose
    • adults and children 12 years and over: take 4 to 8 caplets every 4 hours not to exceed 10 caplets in 24 hours unless directed by a doctor
    • children under 12 years: consult a doctor
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  • Other information

    • each caplet contains: calcium 300 mg, sodium 1 mg
    • contains lactose (milk)
    • store at room temperature. Avoid excessive heat above 40°C (104°F).
    • save carton for full directions and warnings
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  • Inactive ingredients

    carnauba wax, colloidal silicon dioxide, hypromellose, lactose monohydrate, maltodextrin, microcrystalline cellulose, polydextrose, powdered cellulose, pregelatinized starch, sodium starch glycolate, titanium dioxide, triacetin, zinc stearate

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  • QUESTIONS

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

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  • INGREDIENTS AND APPEARANCE
    BAYER WOMENS 
    aspirin tablet, coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0280-2200
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 81 mg
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION 777 mg
    Inactive Ingredients
    Ingredient Name Strength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    TRIACETIN (UNII: XHX3C3X673)  
    ZINC STEARATE (UNII: H92E6QA4FV)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Color white Score no score
    Shape OVAL Size 17mm
    Flavor Imprint Code BAYER
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0280-2200-60 1 in 1 CARTON 01/09/2015
    1 60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 01/09/2015
    Labeler - Bayer HealthCare LLC. (112117283)
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