Label: ASPIRIN tablet, delayed release

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated January 8, 2024

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • ACTIVE INGREDIENT

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

  • PURPOSE

    Pain reliever

  • 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
    • shock
    • asthma (wheezing)

    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 problem
    • take a blood thinning (anticoagulant) or steroid drug
    • take other drug 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
    • if you have ever had an allergic reaction to this product or any of its ingredients
  • ASK DOCTOR

    • 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 DOCTOR/PHARMACIST

    • gout
    • diabetes
    • arthritis
  • STOP USE

    an allergic reaction occurs. Seek medical help right away.
    you experience any of the following signs of stomach bleeding:

    • feel faint
    • have bloody or black stools
    • vomit blood
    • 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
  • PREGNANCY OR BREAST FEEDING

    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.

  • DOSAGE & ADMINISTRATION

    • 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
  • STORAGE AND HANDLING

    • Store at room temprature. Avoid excessive heat above 40°C (104°F).
  • QUESTIONS

    Call 1-609-642-6380 Monday through Friday 9 am to 5 pm EST

  • INACTIVE INGREDIENT

    microcrystalline cellulose, colloidal silicon dioxide,
    croscarmellose sodium, stearic acid, D&C yellow #10, D&C yellow #6 methacrylic
    acid copolymer, talcum, titanium dioxide, triethyl citrate.

  • INDICATIONS & USAGE

    for the temporary relief of minor aches and pains or as recommended by your
    doctor. Because of its delayed action, this product will not provide fast
    relief of headaches or other symptoms needing immediate relief.

    ask your doctor about other uses for Safety Coated 81 mg Aspirin

  • KEEP OUT OF REACH OF CHILDREN

    In case of overdose, get medical help or contact a Poison Control Center right away.

  • PRINCIPAL DISPLAY PANEL

    Display Panel

  • INGREDIENTS AND APPEARANCE
    ASPIRIN 
    aspirin tablet, delayed release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73376-001
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN81 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:2) (UNII: XRK36F13ZZ)  
    TALC (UNII: 7SEV7J4R1U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    Product Characteristics
    ColoryellowScoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code I1
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73376-001-50500 in 1 BOTTLE; Type 0: Not a Combination Product08/10/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01308/10/2022
    Labeler - INVAHEALTH INC (116840615)