Label: BAYER BACK AND BODY EXTRA STRENGTH- aspirin,caffeine tablet

  • NDC Code(s): 0280-2150-02, 0280-2150-10, 0280-2150-24, 0280-2150-50
  • Packager: Bayer HealthCare LLC.
  • Category: HUMAN OTC DRUG LABEL

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 August 2, 2017

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Drug Facts

    Drug Facts

  • Active ingredients (in each caplet)

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

  • Purpose

  • Uses

    for the temporary relief of

    • backache pain
    • muscle aches and pains
    • minor aches and pains of arthritis
  • 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 DOCTOR/PHARMACIST

    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
  • PREGNANCY OR BREAST FEEDING

    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

    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. Avoid excessive heat above 40°C (104°F).
  • 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)

  • PRINCIPAL DISPLAY PANEL

    Carton label 24 count

  • INGREDIENTS AND APPEARANCE
    BAYER BACK AND BODY  EXTRA STRENGTH
    aspirin,caffeine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0280-2150
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE35.5 mg
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    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)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    TRIACETIN (UNII: XHX3C3X673)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVALSize19mm
    FlavorImprint Code BAYER;BACK;BODY
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0280-2150-241 in 1 CARTON01/12/2015
    124 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:0280-2150-501 in 1 CARTON01/12/2015
    250 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    3NDC:0280-2150-101 in 1 CARTON01/12/2015
    3100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    4NDC:0280-2150-02200 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/12/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34301/12/2015
    Labeler - Bayer HealthCare LLC. (112117283)