Label: ASPIRIN ENTERIC COATED- aspirin tablet, coated

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 September 10, 2013

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

  • 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

    • temporarily relieves minor aches and pains due to:
      • headache
      • menstrual pain
      • minor arthritis pain
      • muscle pain
      • toothache
      • colds
      • or as recommended by a 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:

    • 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 have ever had an allergic reaction 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 are taking a diuretic
    • you have asthma

    Ask a doctor or pharmacist before use if you are

    taking a prescription drug for diabetes, gout, or arthritis.

    Stop use and ask a doctor if

    • 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
    • pain gets worse or lasts more than 10 days
    • redness or swelling is present
    • any new symptoms appear
    • ringing in the ears or loss of hearing occurs. 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

    • adults and children 12 years of age or over: take 1 to 2 tablets every 4 hours, while symptoms persist. Drink a full glass of water with each dose.
    • do not take more than 12 tablets in 24 hours unless directed by a doctor
    • children under 12 years of age: ask a doctor
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  • Other information

    • store at controlled room temperature 15°-30°C (59°-86°F)
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  • Inactive ingredients

    corn starch, croscarmellose sodium, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, methacrylic acid copolymer, microcrystalline cellulose, mineral oil, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate

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  • Questions or comments?

    Call 1-800-910-6874

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  • Principal Display Panel

    Compare to active ingredient in Ecotrin®**

    Enteric-coated Aspirin Tablets, 325 mg

    aspirin regimen-pain reliever (NSAID)*

    TABLETS

    GLUTEN FREE

    **This product is not manufactured or distributed by GlaxoSmithKline, owner of the registered trademark Ecotrin®.

    Dist. by Target Corporation

    Minneapolis, MN 55403

    Product of U.S.A.

    Shop Target.com

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

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

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  • Package Label

    Aspirin 325 mg

    Up & Up Enteric coated Aspirin 325 mg Tablet

     

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  • INGREDIENTS AND APPEARANCE
    ASPIRIN  ENTERIC COATED
    aspirin tablet, coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:11673-371
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 325 mg
    Inactive Ingredients
    Ingredient Name Strength
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    Product Characteristics
    Color ORANGE Score no score
    Shape ROUND Size 11mm
    Flavor Imprint Code T
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:11673-371-30 1 in 1 BOX
    1 300 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part343 04/05/2011
    Labeler - TARGET Corporation (006961700)
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