ADULT ASPIRIN REGIMEN LOW DOSE (ASPIRIN) TABLET, COATED [CARDINAL HEALTH]

ADULT ASPIRIN REGIMEN LOW DOSE (ASPIRIN) TABLET, COATED [CARDINAL HEALTH]
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NDC 70000-0218-1
Set ID 9829f56f-723c-473f-89ee-4cb2efb3b8bc
Category HUMAN OTC DRUG LABEL
Packager Cardinal Health
Generic Name
Product Class
Product Number
Application Number PART343
  • 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 or as recommended by your doctor. Because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief.

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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:

    • facial swelling
    • hives
    • shock
    • asthma (wheezing)

    Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:

    • take a blood thinning (anticoagulant) or steroid drug
    • are age 60 or older
    • have 3 or more alcoholic drinks every day while using this product
    • take more or for a longer time than directed
    • have had stomach ulcers or bleeding problems
    • take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]

    Do not use

    • if you are allergic to aspirin or any other pain reliever/fever reducer
    • if you have ever had an allergic reaction to this product or any of its ingredients

    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

    • gout
    • diabetes
    • arthritis 

    Stop use and ask a doctor if

    • an allergic reaction occurs. Seek medical help right away.
    • you experience any of the following signs of stomach bleeding:
      • vomit blood
      • have bloody or black stools
      • feel faint
      • have stomach pain that does not get better
    • ringing in the ears or a loss of hearing occurs
    • pain gets worse or lasts more than 10 days
    • redness or swelling is present
    • new symptoms occur

    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 (1-800-222-1222) right away. 

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  • 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: 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)
    • see end flap for expiration date and lot number
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  • Inactive ingredients

    colloidal anhydrous silica, corn starch, FD&C red #40, FD&C yellow #6, hypromellose, methacrylic acid, microcrystalline cellulose, polydextrose, polyethylene glycol, shellac wax, simethicone, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triacetin, triethyl citrate 

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  • Questions or comments?

    1-800-426-9391 

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  • Principal Display Panel

    NDC 70000-0218-1

    Low Dose | Safety Coated

    Adult Aspirin Regimen**
    Delayed Release, 81 mg | Pain Reliever (NSAID)

    36
    ENTERIC
    COATED TABLETS       ACTUAL SIZE

    COMPARE TO ST. JOSEPH® LOW DOSE SAFETY COATED 81 mg ASPIRIN active ingredient†

    100% Money Back Guarantee

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

    **Talk to your doctor or other healthcare provider before using this product for your heart.

    †This product is not manufactured or distributed by Foundation Consumer Healthcare, LLC, owner of the registered trademark St. Joseph® Low Dose Safety Coated 81 mg Aspirin.

    50844   ORG0318A64507

    DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017
    www.myleader.com   1-800-200-6313

    CARDINAL HEALTH, the Cardinal Health LOGO, LEADER, and the Leader LOGO are trademarks or registered trademarks of Cardinal Health.

    100% Money Back Guarantee
    Return to place of purchase if not satisfied.

    Leader 44-645

    Leader 44-645

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  • INGREDIENTS AND APPEARANCE
    ADULT ASPIRIN REGIMEN  LOW DOSE
    aspirin tablet, coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:70000-0218
    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
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    METHACRYLIC ACID (UNII: 1CS02G8656)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    SHELLAC (UNII: 46N107B71O)  
    Product Characteristics
    Color PINK Score no score
    Shape ROUND Size 6mm
    Flavor Imprint Code L
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:70000-0218-1 1 in 1 CARTON 07/25/2014
    1 36 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part343 07/25/2014
    Labeler - Cardinal Health (097537435)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 038154464 PACK(70000-0218)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 868734088 MANUFACTURE(70000-0218) , PACK(70000-0218)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 967626305 PACK(70000-0218)
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