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Enteric Coated Aspirin (Cardinal Health)

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TABLET 10 BLISTER PACK in 1 BAG (55154-1493-0) > 1 TABLET in 1 BLISTER PACK Label Information

Complete Enteric Coated Aspirin Information

  • ACTIVE INGREDIENT

    Active Ingredient in Each tablet

    Aspirin 81 mg (NSAID*) *Non-steroidal anti-inflammatory drug


  • PURPOSE

    Purpose Pain Reliever

    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.


  • INACTIVE INGREDIENT

    Inactive ingredients: anhydrous lactose, carnauba wax, colloidal silicon dioxide, croscarmellose sodium, D&C 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

    Storage: Store at 25C (77F) excursions permitted between 15-30C (59-86F) - use by expiration date on package


  • 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  


  • PREGNANCY OR BREAST FEEDING

    WARNING: This package is intended for institutional use only. 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 the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

    SKY

    Mfg. By: Time-Cap Labs

    7 Michael Ave.

    Farmingdale, NY 11735

    Dist. By: McKesson Packaging Services

    a business unit of McKesson Corporation

    7101 Weddington Rd. Concord, NC 28027

    *This product is not maufactured or distributed by Bayer Healthcare LLC, owner of the registered trademark Bayer


  • 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


  • WARNINGS

    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 non prescription 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

    Do not use if you are allergic to aspirin or any other pain reliever/ fever reducer

    Ask a doctor before use if you have - stomach bleeding waring 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- under a doctor's care for any serious condition- taking any other drug


  • 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

    Distributed By:

    Cardinal Health

    Dublin, OH 43017

    L4824082-10218

    L4824082-20218


  • Principal Display Panel

    Aspirin Enteric Coated Tablets

    81 mg

    10 Tablets

    bag label

  • INGREDIENTS AND APPEARANCE
    ASPIRIN 
    aspirin tablet, coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:55154-1493(NDC:63739-522)
    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)  
    IRON (UNII: E1UOL152H7)  
    METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    triethyl citrate (UNII: 8Z96QXD6UM)  
    Product Characteristics
    Color YELLOW Score no score
    Shape ROUND Size 7mm
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55154-1493-0 10 in 1 BAG 11/13/2012
    1 1 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part343 11/13/2012
    Labeler - Cardinal Health, Inc. (603638201)