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Bayer (Bayer HealthCare LLC)

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CAPSULE 1 BOTTLE in 1 CARTON (0280-2635-50) > 50 CAPSULE in 1 BOTTLE Label Information

Complete Bayer Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts


  • ACTIVE INGREDIENT

    Active ingredients
    (in each caplet)
    Purpose
    *
    • nonsteroidal anti-inflammatory drug
    Aspirin 500 mg (NSAID)* Pain reliever
    Caffeine 32.5 mg Pain reliever aid

  • Uses

    for the temporary relief of

    • headache
    • muscle aches and pains

  • 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

    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
    • fever gets worse or lasts more than 3 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.


  • Directions

    • drink a full glass of water with each dose
    • adults and children 12 years and over: take 2 caplets every 6 hours not to exceed 8 caplets in 24 hours
    • children under 12 years: consult a doctor

  • Other information

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

  • Inactive ingredients

    carnauba wax, corn starch, D&C red #30 aluminum lake, D&C yellow #10 aluminum lake, hypromellose, powdered cellulose, propylene glycol, shellac, titanium dioxide, triacetin


  • Questions or comments?

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


  • PRINCIPAL DISPLAY PANEL - 50 Caplet Carton

    ASPIRIN (NSAID) / PAIN RELIEVER CAFFEINE / PAIN RELIEVER AID

    BAYER®
    HEADACHE
    RELIEF

    OFFICIAL SPONSOR

    50 Coated Caplets

    FAST, SAFE HEADACHE RELIEF

    DUAL ACTION FORMULA

    Principal Display Panel - 50 Caplet Carton

  • INGREDIENTS AND APPEARANCE
    BAYER   HEADACHE RELIEF
    aspirin and caffeine capsule
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0280-2635
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Aspirin (UNII: R16CO5Y76E) (Aspirin - UNII:R16CO5Y76E) Aspirin 500 mg
    Caffeine (UNII: 3G6A5W338E) (Caffeine - UNII:3G6A5W338E) Caffeine 32.5 mg
    Inactive Ingredients
    Ingredient Name Strength
    Carnauba wax (UNII: R12CBM0EIZ)  
    Starch, corn (UNII: O8232NY3SJ)  
    D&C red no. 30 (UNII: 2S42T2808B)  
    D&C yellow no. 10 (UNII: 35SW5USQ3G)  
    Hypromelloses (UNII: 3NXW29V3WO)  
    Powdered cellulose (UNII: SMD1X3XO9M)  
    Propylene glycol (UNII: 6DC9Q167V3)  
    Shellac (UNII: 46N107B71O)  
    Titanium dioxide (UNII: 15FIX9V2JP)  
    Triacetin (UNII: XHX3C3X673)  
    Product Characteristics
    Color WHITE Score no score
    Shape CAPSULE Size 18mm
    Flavor Imprint Code BAYER;HEADACHE
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0280-2635-50 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 part343 06/01/2012
    Labeler - Bayer HealthCare LLC (785159372)
    Establishment
    Name Address ID/FEI Business Operations
    Bayer HealthCare LLC - Myerstown 072827066 MANUFACTURE(0280-2635)