Label: ASPIRIN 81 MG ENTERIC COATED- aspirin tablet

  • NDC Code(s): 69618-046-02, 69618-046-10
  • Packager: Reliable 1 Laboratories LLC
  • 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 May 10, 2018

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

  • 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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  • PRINCIPAL DISPLAY PANEL

    NDC 69618-046-10

    Enteric Coated

    Aspirin USP 81mg (NSAID

    Adult Low Strength

    PAIN RELIEVER

    THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

    1000 TABLETS

    Aspirin 81 mg EC

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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: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:69618-046-02 120 in 1 BOTTLE; Type 0: Not a Combination Product 05/10/2018
    2 NDC:69618-046-10 1000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/10/2018
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part343 05/10/2018
    Labeler - Reliable 1 Laboratories LLC (079718111)
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