Label: ASPIRIN CHEWABLE- aspirin 81 mg tablet

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

Drug Label Information

Updated January 8, 2025

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

  • Active Ingredient (in each tablet)

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

  • Purpose

    Pain Reliever

  • Uses

    for the 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 three (3) or more alcoholic drinks every day while using this
    • 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 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 stool
    • 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 three (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 childen.

    In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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:

    • Store at room temperature.
  • Inactive ingredients:

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

  • Principal Display Panel

    Aspirin

    81 mg

    Chewable Tablet

    Mfg: Allegiant Health

    Lot:22A0131 Exp:09/06/24

    PKG BY: Safecor Health

    Woburn, MA

    image description
  • INGREDIENTS AND APPEARANCE
    ASPIRIN  CHEWABLE
    aspirin 81 mg tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48433-129(NDC:69168-288)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN81 mg
    Inactive Ingredients
    Ingredient NameStrength
    DEXTRATES (UNII: G263MI44RU)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColororangeScoreno score
    ShapeROUNDSize7mm
    FlavorORANGEImprint Code AZ013
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:48433-129-01100 in 1 BOX11/01/2022
    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 DrugM34311/01/2022
    Labeler - Safecor Health, LLC (828269675)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safecor Health, LLC078805287repack(48433-129) , relabel(48433-129)