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EC-81Aspirin (TriMarc Labs)

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TABLET 365 TABLET in 1 BOTTLE, PLASTIC (68752-022-94) Label Information

Complete EC-81Aspirin Information

  • ACTIVE INGREDIENT

    Active ingredient (in each tablet) PurposeAspirin 81 mg (NSAID*)................................Pain reliever
    *nonsteroidal anti-inflammatory drug


  • INDICATIONS & USAGE

    Uses


    • temporarily relieves minor aches and pains
    • for other uses, see your doctor, but do not use for more than 10 days without consulting your doctor because serious side effects may occur

  • WARNINGS

    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
    • have 3 or more alcoholic drinks every day while using this product
    • take more or for a longer time than directed
    • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)


  • DO NOT USE

    Do not use

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

  • ASK DOCTOR

    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
    • you have not been drinking fluids
    • you have lost a lot of fluid due to vomiting or diarrhea

  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are

    • taking a prescription drug for diabetes, gout, or arthritis
    • taking any other drug
    • under a doctor's care for any serious condition

  • STOP USE

    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
    • pain gets worse or lasts more than 10 days
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present in the painful area
    • any new symptoms appear
    • ringing in the ears or a loss of hearing occurs

  • PREGNANCY OR BREAST FEEDING

    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

    Keep out of reach of children.

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


  • DOSAGE & ADMINISTRATION

    Directions

    • drink a full glass of water with each dose
    • adults and children 12 years and over: 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: consult a doctor

  • STORAGE AND HANDLING

    • Other Informtion
    • store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)
    • use by expiration date on package

  • PURPOSE

    Aspirin 81mg (NSAID*) ........Pain reliever

    *nonsteroidal anti-inflammatory drug


  • INACTIVE INGREDIENT

    Inactive Ingredients Anhydrous Lactose, Carnauba Wax, Colloidal Silicon Dioxide, Croscarmellose Sodium, DC Yellow #10, Aluminum Lake, Iron Oxide Ochre, Methacrylic Acid Copolymer, Microcrystalline Cellulose, Polysorbate 80, Simethicone, Sodium Hydroxide, Sodium Lauryl Sulfate, Talc, Titanium Dioxide, Triethyl Citrate.


  • INGREDIENTS AND APPEARANCE
    EC-81ASPIRIN  ENTERIC COATED
    aspirin tablet, delayed release
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:68752-022(NDC:49483-330)
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 81 mg
    Inactive Ingredients
    Ingredient Name Strength
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    Product Characteristics
    Color yellow Score no score
    Shape ROUND Size 7mm
    Flavor Imprint Code embossed;upper;8;lower;plain
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68752-022-94 365 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/11/2010
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part343 08/11/2010
    Labeler - TriMarc Labs (156893695)
    Registrant - TriMarc Labs (156893695)
    Establishment
    Name Address ID/FEI Business Operations
    TriMarc Labs 156893695 repack(68752-022)