Label: ASPIRIN CHEWABLE- aspirin 81 mg tablet

  • NDC Code(s): 69168-288-01, 69168-288-36
  • Packager: Allegiant Health
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated May 1, 2018

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

  • Active ingredient

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

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  • Purpose

    Pain reliever

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  • Uses

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

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  • 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.

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  • 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.

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  • 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
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  • Inactive Ingredients

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

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  • Package/Label Principal Display Panel

    Chewable Aspirin

    Chewable Aspirin

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  • INGREDIENTS AND APPEARANCE
    ASPIRIN  CHEWABLE
    aspirin 81 mg tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:69168-288
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 81 mg
    Inactive Ingredients
    Ingredient Name Strength
    DEXTRATES (UNII: G263MI44RU)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    Color ORANGE Score no score
    Shape ROUND Size 7mm
    Flavor ORANGE Imprint Code AZ013
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:69168-288-36 1 in 1 CARTON 12/18/2014
    1 36 in 1 BOTTLE; Type 0: Not a Combination Product
    2 NDC:69168-288-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 12/18/2014
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part343 12/18/2014
    Labeler - Allegiant Health (079501930)
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