Label: ASPIRIN 81 MG- aspirin tablet, coated 

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 10/13

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

  • 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

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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:

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

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

    • are age 60 or older
    • have had stomach ulcers or bleeding problems
    • take a blood thinning (anticoagulant) or steroid drug
    • take more or for a longer time than directed
    • take other drugs containing prescription or nonprescription NSAIDs [aspiring, ibuprofen, naproxes, or others]

    Do not use

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

    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 have asthma
    • you are taking a diuretic

    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

    • 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
    • an allergic reaction occurs. Seek medical help right away.
    • new symptoms occur
    • rigning in the ears or loss of hearing occurs
    • pain gets worse or lasts more than 10 days
    • redness or swelling is present

    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 unborn child or complications during deliver.

    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

    corn starch, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, methacrylic acid, microcrystalline cellulose, polydextrose, polyethylene glycol, shellac wax, silica, simethicone, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triacetin, triethyl citrate

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  • Questions or comments?

    Call 1-888-309-9030

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  • Principal Display Panel

    DG
    health

    Compare to active ingredient in Bayer® Low Dose 81 mg Aspirin†

    Aspirin 81 mg
    Pain Reliever (NSAID)
    Low Dose • Enteric Coated

    Aspirin Regimen**

    120 Tablets

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

    50844    REV0612A60032

    DISTRIBUTED BY DOLGENCORP, LLC
    100 MISSION RIDGE
    GOODLETTSVILLE, TN 37072

    Dollar General 44-600A

    Dollar General 44-600A

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  • INGREDIENTS AND APPEARANCE
    ASPIRIN 81 MG 
    aspirin tablet, coated
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:55910-600
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ASPIRIN (ASPIRIN) ASPIRIN 81 mg
    Inactive Ingredients
    Ingredient Name Strength
    FERROSOFERRIC OXIDE  
    SILICON DIOXIDE  
    D&C YELLOW NO. 10  
    FD&C YELLOW NO. 6  
    HYPROMELLOSES  
    CELLULOSE, MICROCRYSTALLINE  
    POLYDEXTROSE  
    POLYETHYLENE GLYCOLS  
    PROPYLENE GLYCOL  
    SODIUM BICARBONATE  
    TITANIUM DIOXIDE  
    TRIACETIN  
    TRIETHYL CITRATE  
    Product Characteristics
    Color YELLOW 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:55910-600-32 1 in 1 CARTON
    1 120 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part343 02/12/2008
    Labeler - DOLGENCORP, LLC (068331990)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 832867894 MANUFACTURE(55910-600)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 038154464 PACK(55910-600)
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