Label: BAYER HEADACHE RELIEF- aspirin and caffeine capsule

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 May 31, 2012

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • 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
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  • Uses

    for the temporary relief of

    • headache
    • muscle aches and pains
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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

    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.

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  • 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
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  • Other information

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

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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 - 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
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  • 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)
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