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

  • NDC Code(s): 60577-807-01
  • 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.

    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 enteric-coated 81 mg Aspirin.
  • INACTIVE INGREDIENT

    corn starch, pregelatinized starch, povidone, microcrystalline celulose, colloidal silicon dioxide, stearic acid, methacrylic acid and ethyl acrylate copolymer, talc, titanium dioxide, triethyl citrate, sodium bicarbonate, sodium lauryl sulfate, d&c yellow #10, hypromellose, triacetin.

  • 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)

  • 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 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 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, have bloody or black stools, vomit blood, 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

    these could be signs of a serious condition.

  • ASK DOCTOR/PHARMACIST SECTION

    Ask a doctor or pharmacist before use if you are

    - taking a prescription drug for gout, diabetes, or arthritis

    - taking any other medication

    - under a doctor’s care for any serious condition

  • 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, have bloody or black stools, vomit blood, 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

    these could be signs of a serious condition.

  • PREGNANCY OR BREAST FEEDING SECTION

    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.

  • ASK A DOCTOR BEFORE USE

    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
  • 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 right away (1-800-222-1222).

  • STORAGE

    • store at 25°C (77°F); excursions permitted between 15°and 30°C (59°and 86°F)
    • -use by expiration date on package.
  • 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
  • PRINCIPAL DISPLAY PANEL

    NDC 60577-807-01

    Vitane's

    Aspirin 81mg

    Pain Reliever -

    Aspirin USP 81 mg (NSAID) Enteric Coated

    60 tablets

    ASPIRIN LABEL ASPIRIN 81 mg IFC

  • INGREDIENTS AND APPEARANCE
    ASPIRIN 81MG 
    aspirin enteric coated tablets 81mg tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60577-807
    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)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    TRIACETIN (UNII: XHX3C3X673)  
    METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER (UNII: NX76LV5T8J)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    POVIDONE (UNII: FZ989GH94E)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    ColoryellowScoreno score
    ShapeROUNDSize5mm
    FlavorImprint Code S;17
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60577-807-011 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
    Aarkish Pharmaceuticals, NJ Inc117729250manufacture(60577-807)