Label: CVS ASPIRIN - aspirin tablet 

  • NDC Code(s): 59779-227-12, 59779-227-13
  • Packager: WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 08/10

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

  • Drug Facts
  • Active ingredient (in each tablet)

    Aspirin 325 mg (NSAID)*

    *nonsteroidal anti-inflammatory drug

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  • Purpose

    Pain reliever

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  • Uses

    • for temporary relief of minor aches and pains due to:
    • headache
    • toothache
    • muscle pain
    • menstrual pain
    • the common cold
    • minor pain of arthritis
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  • 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 sever allergic reaction, which may include:

    • hives
    • shock
    • facial swelling
    • asthma (wheezing)

    Stomach bleeding warning:

    This product contains and (NSAID), which may cause sever 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

    • if you are allergic to aspirin or any other pain reliever/fever reducer

    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 sirrhosis, or kidney disease
    • you have asthma
    • you are taking a diurretic

    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

    • 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
    • an allergic reaction occurs. Seek medical help right away.
    • new symptoms occur
    • ringing in the ears or 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

    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 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.

    In case of overdose, get medical help or contact a Poison Control Center right away.

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  • Directions

    • drink a full glass of water with each dose
    • adults and children 12 years and over: take 1 to 2 tablets every 4 hours while symptoms last. Do not take more than 12 tablets in 24 hours unless directed by a doctor.
    • children under 12 years: do not use unless directed by a doctor
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  • Other Information

    • store in a coool dry place at controlled room temperature 15°-30°C (59°-86°F)
    • see end flap for expiration date and lot number
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  • Inactive Ingredients

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

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  • PRODUCT PACKAGING

    The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.

    CVS®

    pharmacy

    ENTERIC

    ASPIRIN

    Compare to the active ingredient

    in Regulare Strength Ecotrin®†

    See New Warnings

    Information

    ALWAYS SAFETY COATED

    ASPIRIN REGIMEN-PAIN RELIEVER (NSAID)

    325 mg Regular Strength

    100 TABLETS

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

    50844       REV0110C22712

    Distributed by: CVS Pharmacy, Inc.

    One CVS Drive, Woonsocket, RI 02895

    © 2010 CVS/pharmacy

    www.cvs.com       1-800-shop-CVS

    Product Label
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  • INGREDIENTS AND APPEARANCE
    CVS ASPIRIN  
    aspirin tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:59779-227
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Aspirin (Aspirin) Aspirin 325 mg
    Inactive Ingredients
    Ingredient Name Strength
    Ferrosoferric Oxide  
    Silicon Dioxide  
    D&c Yellow No. 10  
    Fd&c Yellow No. 6  
    Hypromellose  
    Polydextrose  
    Polyethylene Glycol  
    Propylene Glycol  
    Sodium Alginate  
    Sodium Bicarbonate  
    Stearic Acid  
    Talc  
    Titanium Dioxide  
    Triacetin  
    Triethyl Citrate  
    Product Characteristics
    Color ORANGE Score no score
    Shape ROUND Size 10mm
    Flavor Imprint Code 44;227
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59779-227-12 1 in 1 CARTON
    1 100 in 1 BOTTLE, PLASTIC
    2 NDC:59779-227-13 1 in 1 CARTON
    2 250 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 12/14/1992
    Labeler - WOONSOCKET PRESCRIPTION CENTER, INCORPORATED (062312574)
    Registrant - L.N.K. International, Inc. (832867837)
    Establishment
    Name Address ID/FEI Business Operations
    L.N.K. International, Inc 832867894 MANUFACTURE
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