Label: BAYER CHEWABLE - ASPIRIN REGIMEN LOW DOSE ASPIRIN CHERRY FLAVORED- aspirin tablet, chewable

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 30, 2023

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Aspirin 81 mg (NSAID) 1


    1
    nonsteroidal anti-inflammatory drug
  • Purpose

    Pain reliever

  • 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

  • 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 Cherry 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

    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 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

    Ask a doctor or pharmacist before use if you are taking a prescription drug for

    ● gout ● diabetes ● arthritis

  • Stop use

    ● 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

  • If pregnant 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

    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

    Other information

    ● save carton for full directions and warnings

    ● store at room temperature

  • Inactive ingredients

    Inactive ingredients colloidal silicon dioxide, corn starch, D&C red #27 aluminum lake, dextrose, FD&C red #40 aluminum lake, flavor, microcrystalline cellulose, saccharin sodium

  • Questions or comments

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

  • 36 count carton

    Carton 36

  • INGREDIENTS AND APPEARANCE
    BAYER CHEWABLE - ASPIRIN REGIMEN  LOW DOSE ASPIRIN CHERRY FLAVORED
    aspirin tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0280-2090
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN81 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeROUNDSize5mm
    FlavorCHERRYImprint Code BAYER
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0280-2090-361 in 1 CARTON07/02/2002
    136 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01307/02/2002
    Labeler - Bayer HealthCare LLC. (112117283)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bayer HealthCare LLC Consumer Care072827066pack(0280-2090) , manufacture(0280-2090)