Label: SAFETY COATED ENTERIC ASPIRIN- aspirin tablet, coated

  • NDC Code(s): 0363-0227-14, 0363-0227-57
  • Packager: WALGREEN CO.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 05/13

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  • Active ingredients (in each tablet)

    Aspirin 325 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

      • 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 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:

    • 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 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

    • 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
    • redness or swelling is present
    • 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

    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 cool dry place at controlled room temperature 15°-30°C (59°-86°F)

    • use by expiration date on package

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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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  • Principal Display Panel

    Well at
    Walgreens
    WALGREENS PHARMACIST RECOMMENDEDǂ

    NDC 0363-0227-57

    ENTERIC COATED
    REGULAR STRENGTH
    Aspirin 325
    325 mg / Pain Reliever (NSAID)

    • Safety coated for aspirin regimen users
    • Easy to swallow

    125 ENTERIC COATED TABLETS

    Compare to Ecotrin® active ingredientǂǂ

    ǂWalgreens Pharmacist Survey Study, November 2010
    ǂǂThis product is not manufactured or distributed by GlaxoSmithKline Consumer Healthcare, owner of the registered trademark Ecotrin®.
    50844    ORG011022757

    TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

    Walgreens 44-227

    Walgreens 44-227

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  • INGREDIENTS AND APPEARANCE
    SAFETY COATED ENTERIC ASPIRIN 
    aspirin tablet, coated
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0363-0227
    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  
    HYPROMELLOSES  
    POLYDEXTROSE  
    POLYETHYLENE GLYCOLS  
    Polyvinyl Acetate Phthalate  
    PROPYLENE GLYCOL  
    SODIUM ALGINATE  
    SODIUM BICARBONATE  
    STEARIC ACID  
    TALC  
    TITANIUM DIOXIDE  
    TRIACETIN  
    TRIETHYL CITRATE  
    Product Characteristics
    Color ORANGE Score no score
    Shape ROUND Size 11mm
    Flavor Imprint Code 44;227
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0363-0227-57 1 in 1 CARTON
    1 125 in 1 BOTTLE, PLASTIC
    2 NDC:0363-0227-14 500 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part343 12/14/1992
    Labeler - WALGREEN CO. (008965063)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 832867837 MANUFACTURE(0363-0227)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 038154464 PACK(0363-0227)
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