Label: BAYER HEADACHE- aspirin and caffeine tablet

  • NDC Code(s): 0280-0064-01, 0280-0064-02
  • Packager: Bayer HealthCare LLC.
  • 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 April 23, 2021

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each caplet) Purpose

    Aspirin 500 mg (NSAID)*………………………...................Pain reliever/fever reducer

    Caffeine 32.5 mg……………………………….....................Pain reliever aid

    *nonsteroidal anti-inflammatory drug

  • PURPOSE

  • Uses

    Uses

    • temporarily relieves minor aches and pains due to:
      • headache
      • toothache
      • colds
      • muscle pain
      • minor pain of arthritis
    • temporarily reduces fever
  • WARNINGS

    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

    ● if you have ever had an allergic reaction to this product or any of its Ingredients

    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.

  • DOSAGE & ADMINISTRATION

    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 SAFETY INFORMATION

    Other information

    ● save carton for full directions and warnings

    ● Store at room temperature. Avoid excessive heat above 40ºC (104ºF).

  • INACTIVE INGREDIENT

    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

    Questions or comments? 1-800-331-4536 (Mon-Fri 9AM - 5PM EST)

  • Package Display 50 Count Carton

    Bayer®

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

    Headache

    FAST RELIEF AT THE SITE OF PAIN

    50 COATED CAPLETS

    500 MG

    Carton 50 count

  • INGREDIENTS AND APPEARANCE
    BAYER HEADACHE 
    aspirin and caffeine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0280-0064
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN500 mg
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE32.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6)  
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SHELLAC (UNII: 46N107B71O)  
    TRIACETIN (UNII: XHX3C3X673)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVALSize17mm
    FlavorImprint Code Bayer;Headache
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0280-0064-011 in 1 CARTON04/28/2021
    1100 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:0280-0064-021 in 1 CARTON04/28/2021
    250 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34304/28/2021
    Labeler - Bayer HealthCare LLC. (112117283)