Label: ASPIRIN tablet, delayed release

  • NDC Code(s): 69842-927-14, 69842-927-57
  • Packager: CVS PHARMACY
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated May 23, 2023

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  • Active ingredient (in each tablet)

    Aspirin 325 mg (NSAID)*
    *nonsteroidal anti-inflammatory drug

  • Purpose

    Pain reliever

  • Uses

    • temporarily relieves minor aches and pains due to:
      • minor pain of arthritis
      • headache
      • menstrual pain
      • a cold
      • toothache
      • muscle pain
    • or as recommended by your doctor
  • 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
    • shock
    • facial swelling
    • 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 3 or more alcoholic drinks every day while using this product
    • 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]
    • 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 a doctor before use if

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

    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:
      • feel faint
      • vomit blood
      • 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 1 to 2 tablets every 4 hours not to exceed 12 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)
    • see end flap for expiration date and lot number
  • Inactive ingredients

    black iron oxide, cellulose, colloidal anhydrous silica, corn starch, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, polydextrose, polyethylene glycol, polyvinyl acetate phthalate, propylene glycol, shellac wax, simethicone, sodium alginate, sodium bicarbonate, stearic acid, talc, titanium dioxide, triacetin, triethyl citrate

  • Questions or comments?

    1-800-426-9391

  • Principal Display Panel

    ♥︎CVS Health

    Compare to the active ingredient in Ecotrin® Regular Strength†
    Coated Tablets

    Regular Strength

    Aspirin
    325 mg
    Pain reliever (NSAID)

    Arthritis
    Pain Relief    ‡

    ‡Temporarily relieves
    minor pain of arthritis

    Actual Size
    Safety
    Coated

    125 ENTERIC
    COATED TABLETS

    Package Contains
    One Bottle

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

    †This product is not manufactured or distributed by
    Medtech Products Inc., owner of the registered trademark
    Ecotrin® Regular Strength.         50844    REV0122B22757

    Distributed by: CVS Pharmacy, Inc.
    One CVS Drive, Woonsocket, RI 02895
    © 2022 CVS/pharmacy V-11112

    CVS 44-227

    CVS 44-227

  • INGREDIENTS AND APPEARANCE
    ASPIRIN 
    aspirin tablet, delayed release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-927
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 mg
    Inactive Ingredients
    Ingredient NameStrength
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    Polyvinyl Acetate Phthalate (UNII: 58QVG85GW3)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHELLAC (UNII: 46N107B71O)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM ALGINATE (UNII: C269C4G2ZQ)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    Product Characteristics
    ColororangeScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code 44;227
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-927-571 in 1 CARTON03/01/2019
    1125 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:69842-927-14500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34303/01/2019
    Labeler - CVS PHARMACY (062312574)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464manufacture(69842-927) , pack(69842-927)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837manufacture(69842-927)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894manufacture(69842-927)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088manufacture(69842-927)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305pack(69842-927)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.117025878manufacture(69842-927)
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