Label: ASPIRIN CHEWABLE- aspirin 81 mg tablet

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated October 29, 2024

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  • Active ingredient

    Aspirin 81 mg (NSAID*)
    *nonsteroidal anti-inflammatory drug

  • Purpose

    Pain reliever

  • Uses

    temporary relief of minor aches and pains or as recommended by your doctor

  • 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

  • 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
    •
    redness or swelling is present
    •
    new symptoms occur
    •
    ringing in the ears or 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 specifically 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 accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

  • 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
    •
    do not use if imprinted safety seal under cap is broken or missing
    •
    Do not use if blister card is damaged or appears to have been tampered
  • Inactive Ingredients

    corn starch, dextrates, FD&C yellow #6 aluminum lake, orange flavor, saccharin sodium 

  • Questions or comments

    1-888-952-0050 (Mon-Fri 9AM-5PM EST)

  • Sky

    Mfg. By: Allegiant Health, Deer Park, NY 11729

    Dist. By: McKesson Corporation, Memphis, TN 38141

    + This product is not manufactured or distributed by Bayer Healthcare LLC, owner of the registered trademark Bayer®

  • Distributed By:

    Cardinal Health

    Dublin, OH 43017

    L5874656-11024 / L5874656-21024

    WARNING: This Unit Dose package is not child resistant and Intended for Institutional Use Only.

  • Principal Display Panel

    ASPIRIN CHEWABLE TABLETS,

    81 mg (NSAID*)

    10 TABLETS

    81mg bag label
  • INGREDIENTS AND APPEARANCE
    ASPIRIN  CHEWABLE
    aspirin 81 mg tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55154-8149(NDC:63739-434)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN81 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    DEXTRATES (UNII: G263MI44RU)  
    FD&C YELLOW NO. 6 ALUMINUM LAKE (UNII: GYP6Z2JR6Q)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Product Characteristics
    ColororangeScoreno score
    ShapeROUNDSize7mm
    FlavorORANGEImprint Code AZ013
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55154-8149-010 in 1 BAG07/02/2024
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01307/02/2024
    Labeler - Cardinal Health 107, LLC (118546603)
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