Label: ASPIRIN CHEWABLE- aspirin 81 mg tablet

  • NDC Code(s): 69168-288-01, 69168-288-36
  • Packager: Allegiant Health
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 21, 2018

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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 aspirinor 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
  • Inactive Ingredients

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

  • Package/Label Principal Display Panel

    Chewable Aspirin

    Chewable Aspirin

  • INGREDIENTS AND APPEARANCE
    ASPIRIN  CHEWABLE
    aspirin 81 mg tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)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:69168-288-361 in 1 CARTON12/18/2014
    136 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:69168-288-01100 in 1 BOTTLE; Type 0: Not a Combination Product12/18/201406/30/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01312/18/2014
    Labeler - Allegiant Health (079501930)