Label: ASPIRIN 81MG- aspirin enteric coated tablets 81mg tablet, delayed release

  • NDC Code(s): 60577-808-01
  • Packager: VITANE PHARMACEUTICALS, INC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 15, 2025

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

  • ACTIVE INGREDIENT

    Aspirin 81 mg (NSAID*)

    *nonsteroidal anti-inflamatory drug

  • PURPOSE

    Pain reliever

  • USES

    • Temporarily relieves minor aches and pains
    • For use as directed by a doctor for the prevention of recurrent heart attack or stroke

    Because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief.

  • 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

    Allergy Alert:

    • Aspirin may cause a severe allergic reaction which may include:
    • hives
    • facial swelling
    • asthma (wheezing)
    • shock
  • SPL UNCLASSIFIED SECTION

    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 non-prescription NSAIDs(aspirin, ibuprofen, naproxen, 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 SECTION

    Do not use if:

    You are allergic to aspirin or any other pain reliever/fever reducer.

  • ASK A DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are taking a prescription drug for

    • gout
    • diabetes
    • arthritis
  • STOP USE SECTION

    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.
  • PREGNANCY OR BREAST FEEDING SECTION

    If pregnant or breast-feeding, ask a health professional.

    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 SECTION

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

  • DIRECTIONS

    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
  • STORAGE

    • Store at 25°C (77°F); excursions permitted between 15°C and 30°C (59°F–86°F)
    • Use by expiration date on package.
  • INACTIVE INGREDIENTS

    Microcrystalline Cellulose, Talc, Croscarmellose Sodium, Stearic Acid, Colloidal Silicon Dioxide, Titanium Dioxide, Triethyl Citrate, Methacrylic Acid and Ethyl Acrylate Copolymer, D&C Yellow #10, FD&C Yellow #6

  • ASK A DOCTOR BEFORE USE

    • Stomach bleeding warning applies to you
    • You have a history of stomach problems, such as heartburn
    • You have a high blood pressure, heart disease, liver cirrhosis, or kidney disease
    • You are taking a diuretic
    • You have asthma
  • PRINCIPAL DISPLAY PANEL

    NDC 60577-808-01

    Vitane's

    Aspirin 81mg

    Pain Reliever

    Aspirin 81 mg (NSAID) Enteric Coated

    60 tablets

    Aspirin 81mg LabelASPIRIN 81 mg IFC

  • INGREDIENTS AND APPEARANCE
    ASPIRIN 81MG 
    aspirin enteric coated tablets 81mg tablet, delayed release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60577-808
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN81 mg
    Inactive Ingredients
    Ingredient NameStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER (UNII: NX76LV5T8J)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    TALC (UNII: 7SEV7J4R1U)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    ColoryellowScoreno score
    ShapeROUNDSize4mm
    FlavorImprint Code I1
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60577-808-011 in 1 CARTON10/15/2025
    160 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01310/15/2025
    Labeler - VITANE PHARMACEUTICALS, INC (029029638)
    Establishment
    NameAddressID/FEIBusiness Operations
    InvaHealth Inc116840615manufacture(60577-808)