Label: ASPIRIN LOW DOSE SAFETY COATED- aspirin tablet, coated 

  • NDC Code(s): 55316-227-12, 55316-227-30
  • Packager: Healthy Accents (DZA Brands, LLC)
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 02/13

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. 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 safety 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 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 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 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

    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
    • pain gets worse or lasts more than 10 days
    • redness or swelling is present
    • ringing in the ears or loss of hearing occurs

    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 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
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  • Other information

    • store at controlled room temperature 15º-30ºC (59º-86ºF)
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  • Inactive ingredients

    anhydrous lactose**, black iron oxide**, brown iron oxide**, croscarmellose sodium**, D&C yellow #10, FD&C yellow #6**, hypromellose**, methacrylic acid copolymer, microcrystalline cellulose, mineral oil**, polysorbate 80**,  potassium hydroxide**, pregelatinized starch**, propylene glycol**, purified water**, shellac**, silicon dioxide, simethicone**, sodium bicarbonate**, sodium hydroxide**, sodium lauryl sulfate**, stearic acid**, talc, titanium dioxide, triethyl citrate, yellow iron oxide**

    **contains one or more of these ingredients 

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  • Questions or comments?

    Call toll free 1-866-322-2439

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  • Principal Display Panel

    Compare to Bayer® Low Dose Aspirin active ingredient†

    Aspirin 81 mg

    Pain Reliever (NSAID)

    Low Dose Safety Coated

    Aspirin Regimen‡

    ENTERIC COATED TABLETS

    †This product is not manufactured or distributed by Bayer HealthCare LLC, owner of the registered trademark Bayer® Low Dose Aspirin.

    ‡Aspirin is not appropriate for everyone, so be sure you talk to your doctor before you begin an aspirin regimen.

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

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

    Distributed by: DZA Brands, LLC

    Salisbury, NC  28147

    Scarborough, ME  04074

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  • Product Label

    Aspirin 81 mg

    Healthy Accents Aspirin 81 mg Low Dose Safety Coated Tablets

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  • INGREDIENTS AND APPEARANCE
    ASPIRIN  LOW DOSE SAFETY COATED
    aspirin tablet, coated
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:55316-227
    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
    POLYSORBATE 80  
    DIMETHICONE  
    SODIUM HYDROXIDE  
    SODIUM LAURYL SULFATE  
    TALC  
    TRIETHYL CITRATE  
    ANHYDROUS LACTOSE  
    FERROSOFERRIC OXIDE  
    BROWN IRON OXIDE  
    CROSCARMELLOSE SODIUM  
    D&C YELLOW NO. 10  
    FD&C YELLOW NO. 6  
    HYPROMELLOSES  
    METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)  
    CELLULOSE, MICROCRYSTALLINE  
    MINERAL OIL  
    POTASSIUM HYDROXIDE  
    STARCH, CORN  
    PROPYLENE GLYCOL  
    WATER  
    SHELLAC  
    SILICON DIOXIDE  
    SODIUM BICARBONATE  
    STEARIC ACID  
    TITANIUM DIOXIDE  
    FERRIC OXIDE YELLOW  
    Product Characteristics
    Color YELLOW Score no score
    Shape ROUND Size 7mm
    Flavor Imprint Code E;T81;1
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55316-227-30 1 in 1 BOX
    1 300 in 1 BOTTLE, PLASTIC
    2 NDC:55316-227-12 1 in 1 BOX
    2 120 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part343 03/01/2013
    Labeler - Healthy Accents (DZA Brands, LLC) (090322194)
    Registrant - P and L Development of New York Corporation (800014821)
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