BAYER ASPIRIN REGIMEN CHEWABLE LOW DOSE ASPIRIN ORANGE- aspirin tablet, chewable

Bayer Aspirin Regimen Chewable by

Drug Labeling and Warnings

Bayer Aspirin Regimen Chewable by is a Otc medication manufactured, distributed, or labeled by Bayer HealthCare LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

  • Purpose

    Pain reliever

  • Uses

    • for the temporary relief of minor aches and pains or as recommended by your doctor
    • ask your doctor about other uses for Bayer 81 mg Orange Chewable Aspirin
  • 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
    • this product for at least 7 days after tonsillectomy or oral surgery unless directed by a doctor
    • if you have ever had an allergic reaction to this product or any of its ingredients
  • 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 4 to 8 tablets every 4 hours not to exceed 48 tablets in 24 hours unless directed by a doctor
    • children under 12 years: consult a doctor
  • Other information

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

    colloidal silicon dioxide, corn starch, dextrose, FD&C yellow #6 aluminum lake, flavor, microcrystalline cellulose, saccharin sodium

  • QUESTIONS

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

  • 36 count carton

    Carton 36 count

  • INGREDIENTS AND APPEARANCE
    BAYER ASPIRIN REGIMEN CHEWABLE  LOW DOSE ASPIRIN ORANGE
    aspirin tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 0280-2080
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN81 mg
    Inactive Ingredients
    Ingredient NameStrength
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Product Characteristics
    ColororangeScoreno score
    ShapeROUNDSize5mm
    FlavorORANGEImprint Code BAYER
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 0280-2080-181 in 1 CARTON01/11/2015
    118 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC: 0280-2080-361 in 1 CARTON01/11/2015
    236 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34301/11/2015
    Labeler - Bayer HealthCare LLC. (112117283)

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