Label: ENTERIC ASPIRIN- aspirin tablet, coated

  • NDC Code(s): 59779-439-29, 59779-439-51
  • 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 09/13

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

  • Active ingredient (in each tablet)

    Aspirin 81 mg (NSAID)*

    *nonsteroidal anti-inflammatory drug

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  • Purpose

    Pain reliever

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  • Uses

    • for the temporary relief of minor aches and pains due to:
      • headache
      • muscle pain
      • toothache
      • the common cold
      • minor pain of arthrtitis
      • menstrual pain
    • or as recommended by your doctor 
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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 severe allergic reaction, which may include:

    • asthma (wheezing)
    • hives
    • facial swelling
    • 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 (anticoabulant) or steroid drug
    • take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxes, or others]
    • have 3 or more alcoholic drinks ever 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 or 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 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
    • have bloody or black stools
    • vomit blood
    • 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 complication 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 overL 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 
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  • Other information

    • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
    • avoid excessive heat and humidity
    • see end flap for expiration date and lot number 
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  • Inactive ingredients

    colloidal silicon dioxide, corn starch, croscarmellose sodium, D&C yellow #10, FD&C yellow #6, hypromellose, microcrystalline cellulose, polydextrose, polyethylene glycol, polyvinyl acetate phthalate, shellac wax, simethicone, sodium alginate, sodium bicarbonate, stearic acid, talc, titanium dioxide, triacetin, triethyl citrate

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  • Questions or comments?

    1-800-426-9391

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  • Principal Display Panel

    CVS
    pharmacy®

    Compare to the active ingredient in Ecotrin® 81 mg Low Strength Aspirin†

    ENTERIC
    ASPIRIN
    ALWAYS SAFETY COATED
    PAIN RELIEVER (NSAID)
    ASPIRIN REGIMEN
    ALWAYS SAFETY COATED
    81 mg low strength

    365 COATED TABLETS

    †This product is not manufactured or distributed by Pfizer Consumer Healthcare, owner of the registered trademark Ecotrin® 81 mg Low Strength Aspirin.
    50844    REV0113C43951

    Distributed by: CVS/pharmacy, Inc.
    One CVS Drive, Woonsocket, RI 02895
    ©2013 CVS/pharmacy
    www.cvs.com    1-800-shop-CVS

    V-11112

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSINGCVS 44-439A

    CVS 44-439A

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  • INGREDIENTS AND APPEARANCE
    ENTERIC ASPIRIN 
    aspirin tablet, coated
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:59779-439
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ASPIRIN (ASPIRIN) ASPIRIN 81 mg
    Inactive Ingredients
    Ingredient Name Strength
    SILICON DIOXIDE  
    CROSCARMELLOSE SODIUM  
    D&C YELLOW NO. 10  
    FD&C YELLOW NO. 6  
    HYPROMELLOSES  
    POLYDEXTROSE  
    POLYETHYLENE GLYCOLS  
    DIMETHICONE  
    SODIUM ALGINATE  
    SODIUM BICARBONATE  
    STEARIC ACID  
    TITANIUM DIOXIDE  
    TALC  
    TRIACETIN  
    TRIETHYL CITRATE  
    Product Characteristics
    Color ORANGE Score no score
    Shape ROUND Size 8mm
    Flavor Imprint Code L
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59779-439-51 1 in 1 CARTON
    1 365 in 1 BOTTLE, PLASTIC
    2 NDC:59779-439-29 1 in 1 CARTON
    2 150 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part343 04/14/2004
    Labeler - WOONSOCKET PRESCRIPTION CENTER,INCORPORATED (062312574)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 038154464 PACK(59779-439)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 832867894 MANUFACTURE(59779-439)
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