Label: ASPIRIN ENTERIC COATED- aspirin tablet, delayed release

  • NDC Code(s): 59779-600-06, 59779-600-07, 59779-600-14, 59779-600-16, view more
    59779-600-17, 59779-600-27, 59779-600-29, 59779-600-32, 59779-600-90, 59779-600-91, 59779-600-99
  • Packager: CVS Pharmacy
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 20, 2023

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

  • Active ingredient (in each tablet)

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

  • Purpose

    Pain reliever

  • Uses

    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.

  • 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

    • take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
    • are age 60 or older
    • take more or for a longer time than directed
    • have had stomach ulcers or bleeding problems
    • have 3 or more alcoholic drinks every day while using this product
    • take a blood thinning (anticoagulant) or steroid drug

    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 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 have asthma
    • you are taking a diuretic

    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:
      • vomit blood
      • feel faint
      • have bloody or black stools
      • have stomach pain that does not get better
    • ringing in the ears or a loss of hearing occurs
    • 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

    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 at 20 weeks or later in 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.

  • Directions

    • do not take more than directed
    • 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 at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
    • use by expiration date on package
  • Inactive ingredients

    corn starch, D&C yellow #10, FD&C yellow #6, hypromellose, methacrylic acid, microcrystalline cellulose, polydextrose, polyethylene glycol, shellac wax, silica, simethicone, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triacetin, triethyl citrate

  • Questions or comments?

    1-800-426-9391

  • Principal Display Panel

    ♥CVS
    Health®

    Compare to the active ingredient
    in Bayer® Low Dose Aspirin

    Coated Tablets

    Low Dose
    Aspirin

    Pain Reliever (NSAID)

    • Safety Coated
    • Aspirin Regimen§

    81
    mg

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

    Actual
    Size

    500 ENTERIC COATED TABLETS

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED
    SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

    This product is not manufactured or distributed by Bayer AG, owner of the
    registered trademark Bayer® Low Dose Aspirin.       50844           REV0122C60014

    Distributed by: CVS Pharmacy, Inc.
    One CVS Drive, Woonsocket, RI 02895
    © 2022 CVS/pharmacy
    CVS.com®
    1-800-SHOP CVS

    100% money back
    guaranteed.

    CVS.com/returnpolicy

    CVS 44-600A

    CVS 44-600A

  • INGREDIENTS AND APPEARANCE
    ASPIRIN  ENTERIC COATED
    aspirin tablet, delayed release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-600
    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)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    METHACRYLIC ACID (UNII: 1CS02G8656)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SHELLAC (UNII: 46N107B71O)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    Product Characteristics
    ColoryellowScoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code L
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-600-271 in 1 CARTON05/01/2011
    132 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:59779-600-321 in 1 CARTON05/01/2011
    2120 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    3NDC:59779-600-061 in 1 CARTON05/01/2011
    3200 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    4NDC:59779-600-17300 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/01/2011
    5NDC:59779-600-14500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/01/2011
    6NDC:59779-600-161000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/01/2011
    7NDC:59779-600-071 in 1 CARTON05/01/201110/19/2017
    736 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    8NDC:59779-600-992 in 1 CARTON05/01/201110/19/2017
    8120 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    9NDC:59779-600-291 in 1 CARTON05/01/201110/19/2017
    9150 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    10NDC:59779-600-901 in 1 CARTON05/01/201107/13/2022
    10230 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    11NDC:59779-600-91360 in 1 BOTTLE; Type 0: Not a Combination Product05/01/201107/13/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01305/01/2011
    Labeler - CVS Pharmacy (062312574)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837manufacture(59779-600)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894manufacture(59779-600)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088manufacture(59779-600) , pack(59779-600)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.117025878manufacture(59779-600)