Label: BAYER AM EXTRA STENGTH- aspirin and caffeine tablet 

  • NDC Code(s): 0280-2600-50
  • Packager: Bayer HealthCare LLC, Consumer Care
  • 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 03/10

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • ACTIVE INGREDIENT

    Active ingredients (in each tablet) Purpose
    *
    nonsteroidal anti-inflammatory drug
    Aspirin 500 mg (NSAID)* Pain reliever
    Caffeine 65 mg Alertness aid
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  • Uses

    • for the temporary relief of minor aches and pains associated with a hangover
    • helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness associated with a hangover
    • also effective for headache, body aches and pains alone
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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
    • in children under 12 years of age

    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
    • new symptoms occur
    • ringing in the ears or a loss of hearing occurs

    When using this product

    • the recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat.
    • take for occasional use only. Do not use for more than 2 days for a hangover unless directed by a doctor. Not intended for use as a substitute for sleep. If fatigue or drowsiness persists or continues to recur, consult a doctor.

    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 2 tablets every 6 hours not to exceed 8 tablets in 24 hours
    • children under 12 years: consult a doctor
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  • Other information

    store at room temperature

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  • Inactive ingredients

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

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  • Questions or comments?

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

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  • PRINCIPAL DISPLAY PANEL - 50 Tablet Carton

    See new warnings information

    NEW!

    Aspirin (NSAID)/Pain Reliever Caffeine/Alertness Aid

    BAYER®

    AM
    extra strength
    ASPIRIN + ALERTNESS AID

    TARGETS TOUGH MORNING PAINS

    Increases Alertness
    Reduces Fatigue

    50
    TABLETS

    PRINCIPAL DISPLAY PANEL - 50 Tablet Carton
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  • INGREDIENTS AND APPEARANCE
    BAYER  AM EXTRA STENGTH
    aspirin and caffeine tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0280-2600
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Aspirin (Aspirin) Aspirin 500 mg
    Caffeine (Caffeine) Caffeine 65 mg
    Product Characteristics
    Color WHITE Score no score
    Shape ROUND Size 25mm
    Flavor Imprint Code AM
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0280-2600-50 1 in 1 CARTON
    1 50 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part341 04/15/2010
    Labeler - Bayer HealthCare LLC, Consumer Care (785159372)
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