ASPIRIN 81 MG ENTERIC COATED (ASPIRIN) TABLET [QUALITY CARE PRODUCTS, LLC]

ASPIRIN 81 MG ENTERIC COATED (ASPIRIN) TABLET [QUALITY CARE PRODUCTS, LLC]
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NDC 55700-746-60
Set ID 0d3fcc4f-5b8a-43ee-9bad-ba35dc8dc948
Category HUMAN OTC DRUG LABEL
Packager Quality Care Products, LLC
Generic Name
Product Class
Product Number
Application Number PART343
  • Drug Facts
  • Active ingredients (in each tablet)

    Aspirin 81 mg (NSAID*)

    *nonsteroidal anti-inflammatory drug

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  • Purpose

    Pain reliever

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  • Uses

    • temporarily relieves minor aches and pains

    Because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief.

    • ask your doctor about other uses for enteric-coated 81 mg Aspirin
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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 symptons could be an early sign of Reye's syndrome, a rare but serious illness.

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  • OTHER SAFETY INFORMATION

    Allergy alert: Aspirin may cause a severe allergic reaction, which any include:

    • hives
    • facial swelling
    • shock
    • asthma (wheezing)
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  • SPL UNCLASSIFIED SECTION

    Somach bleeding warning: This product contains 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 steriod 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
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  • DO NOT USE

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

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  • 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 dirinking fluids
    • you have lost a lot of fluid due to vomiting or diarrhea

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  • 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
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  • STOP USE

    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:

    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
    • redness or swelling is present
    • new symptoms occur
    • ringing in the ears or a loss of hearing occurs

    These could be sings of a serious condition.

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  • PREGNANCY OR BREAST FEEDING

    If pregnant or brest-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 conplications during delivery.

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  • 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.

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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: consult a doctor
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  • Other information

    • store at 25ºC (77ºF) excursions permitted between 15º-30ºC (59º-86ºF)
    • use by expiration date on package
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  • Inactive ingredients

    anhydrous lactose, carnauba wax, colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10 aluminum lake, iron oxide ochre, methacrylic acid and ethyl acrylate copolymer, microcrystalline cellulose, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, starch, talc, titanium dioxide, triethyl citrate

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  • Questions or comments?

    call 516-341-0666, 8:30 am - 4:30 pm ET, Monday - Friday

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  • INGREDIENTS AND APPEARANCE
    ASPIRIN 81 MG ENTERIC COATED 
    aspirin tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:55700-746(NDC:69618-046)
    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
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TALC (UNII: 7SEV7J4R1U)  
    IRON (UNII: E1UOL152H7)  
    METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    Product Characteristics
    Color yellow Score no score
    Shape ROUND Size 5mm
    Flavor Imprint Code Heart
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55700-746-60 60 in 1 BOTTLE; Type 0: Not a Combination Product 04/26/2019
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part343 04/26/2019
    Labeler - Quality Care Products, LLC (831276758)
    Establishment
    Name Address ID/FEI Business Operations
    Quality Care Products, LLC 831276758 repack(55700-746)
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