Label: BAYER FAST RELEASE- aspirin powder 

  • Label RSS
  • NDC Code(s): 0280-2500-10
  • Packager: Bayer Corporation Consumer Care Division
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 06/10

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient (in each powder pouch)

    Aspirin 500 mg (NSAID)1


    1
    nonsterodial anti-inflammatory drug
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  • Purposes

    Pain reliever/fever reducer

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  • Uses

    temporarily relieves

    • headache
    • toothache
    • pain and fever of colds
    • minor pain of arthritis
    • muscle pain
    • menstrual pain
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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
    • asthma (wheezing)
    • facial swelling
    • 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
    • this product for at least 7 days after tonsillectomy or oral surgery unless directed by a doctor

    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.

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  • Directions

    • adults and children 12 years and over: take contents of 1 powder pouch every 4 hours. Dissolve powder on tongue, followed by a full glass of water. Do not exceed 8 powder pouches in 24 hours.
    • children under 12 years: consult a doctor
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  • Other information

    • Phenylketonurics: Contains Phenylalanine 5.6 mg Per Powder Pouch
    • save carton for full directions and warnings
    • store at room temperature
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  • Inactive ingredients

    acesulfame potassium, anhydrous citric acid, aspartame, flavor, isomalt

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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 - 500 mg Pouch Carton

    See new warings information

    NEW!

    Aspirin (NSAID) Pain Reliever/Fever Reducer

    BAYER®

    EXTRA STRENGTH

    FAST RELEASE
    POWDER

    Dissolves Quickly
    on your Tongue for
    FAST PAIN RELIEF

    citrus burst

    10 SINGLE DOSE
    POUCHES

    Principal Display Panel - 500 mg Pouch Carton
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  • INGREDIENTS AND APPEARANCE
    BAYER  FAST RELEASE
    aspirin powder
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0280-2500
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Aspirin (Aspirin) Aspirin 500 mg
    Product Characteristics
    Color WHITE Score     
    Shape Size
    Flavor CITRUS Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0280-2500-10 10 in 1 CARTON
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part341 06/30/2010
    Labeler - Bayer Corporation Consumer Care Division (785159372)
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