Label: ADULT CHEWABLE ASPIRIN- aspirin tablet, chewable

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

Drug Label Information

Updated October 17, 2024

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each tablet)

    Aspirin 81 mg (NSAID)*

    * nonsteroidal anti-inflammatory drug

  • Purpose

    Pain reliever

  • Uses

    • temporarily relieves minor aches and pains
    • ask your doctor about other uses for this product
  • 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 have ever had an allergic reaction to any other pain reliever/fever reducer
    • 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
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present
    • new symptoms occur
    • ringing in the ears or a loss of hearing occurs

    These could be signs of a serious condition.

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

  • 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: do not use unless directed by a doctor
  • Other information

    • store between 20°-25°C (68°-77°F) in a dry place
    • retain carton for complete product information and warnings
  • Inactive ingredients

    corn starch, FD&C yellow #6 aluminum lake, flavor, magnesium stearate, silicon dioxide, sucrose

  • Questions or comments?

    1-844-705-4384

  • PRINCIPAL DISPLAY PANEL

    Discount Drug Mart Food Market

    NDC 53943-152-01

    †Compare to the active ingredient in St. Joseph® Low Dose Chewable Aspirin

    Low Dose

    Adult Chewable Aspirin

    Pain Reliever (NSAID)

    Actual Size

    ADULT ASPIRIN REGIMEN**

    ORANGE FLAVORED

    Talk to your doctor or other healthcare provider before using this product for your heart.

    36 TABLETS

    81 MG EACH

    image description

  • INGREDIENTS AND APPEARANCE
    ADULT CHEWABLE ASPIRIN 
    aspirin tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53943-152
    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)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColororangeScoreno score
    ShapeROUNDSize8mm
    FlavorORANGEImprint Code AP;009
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53943-152-011 in 1 CARTON09/24/2021
    136 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01309/24/2021
    Labeler - DISCOUNT DRUG MART (047741335)