Label: ASPIRIN 81MG ENTERIC COATED DELAYED RELEASE- aspirin tablet, coated

  • NDC Code(s): 69168-405-17, 69168-405-40
  • Packager: Allegiant Health
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 2, 2021

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

  • Active ingredient(s)

    Aspirin 81mg (NSAID)*

  • Purpose

    Pain reliever

  • Use(s)

    • for the temporary relief of minor aches and pain 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 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 non prescription 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 other pain reliever/fever reducer
    • if you have ever had an allergic reaction to this product or any of its ingredients

    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

    • anticoagulation (thinning of the blood)
    • diabetes
    • gout
    • 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
    • You may report serious side effects to 1-888-952-0050

    Pregnancy/Breastfeeding

    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.

    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

    • 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 of age: consult a doctor
  • Other information

    • save carton for full directions and warnings
    • store at room temperature
    • do not use if imprinted safety seal under cap is broken or missing
  • Inactive ingredients

    anhydrous lactose, carnauba wax, colloidal silicon dioxide, croscarmellose sodium, D&C yellow

    #10 aluminum lake, iron oxide ochre, methacrylic acid copolymer, microcrystalline cellulose, polysorbate 80,

    simethicone, sodium hydroxide, sodium lauryl sulfate, starch, talc, titanium dioxide, triethyl citrate

  • Questions

    1-888-952-0050, Monday Through Friday 9am-5pm

  • Principal Display Panel

    Aspirin 81mg

    Aspirin 81mg


  • INGREDIENTS AND APPEARANCE
    ASPIRIN 81MG ENTERIC COATED  DELAYED RELEASE
    aspirin tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69168-405
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN81 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6)  
    BROWN IRON OXIDE (UNII: 1N032N7MFO)  
    METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SODIUM HYDRIDE (UNII: 23J3BHR95O)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    Product Characteristics
    ColoryellowScoreno score
    ShapeROUNDSize7mm
    FlavorImprint Code HEART
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69168-405-401 in 1 CARTON12/15/2021
    140 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:69168-405-17300 in 1 BOTTLE; Type 0: Not a Combination Product12/15/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01312/15/2021
    Labeler - Allegiant Health (079501930)