Label: ASSURED ASPIRIN- aspirin tablet, delayed release

  • NDC Code(s): 68210-0015-6
  • Packager: SPIRIT PHARMACEUTICALS LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 March 15, 2018

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient (in each tablet)

    Aspirin 81 mg (NSAID) 1


    1
    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, fever or other symptoms needing immediate relief.
    • ask your doctor about other uses for Aspirin 81 mg
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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
    • asthma (wheezing)
    • shock

    Stomach bleeding warning

    This product contains an NSAID, which may cause 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 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 right away.
    • you experience any of the following signs of stomach bleeding:
      • feel faint
      • vomit blood
      • have bloody or black stools
      • 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

    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: consult a doctor
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  • Other information

    • each tablet contains: sodium 0.36 mg
    • save carton for full directions and warnings
    • store at room temperature
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  • Inactive ingredients

    acrycoat, colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10, lactose, microcrystalline cellulose, polysorbate 80, sodium hydroxide, talc, titanium dioxide, triethyl citrate, yellow oxide of iron

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  • Questions or comments?

    1-888-333-9792

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  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY
    GREENBRIER INTERNATIONAL, INC.
    500 VOLVO PARKWAY, CHESAPEAKE, VA 23320

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  • PRINCIPAL DISPLAY PANEL - 60 Tablet Bottle Carton

    ASSURED

    COMPARE TO ACTIVE INGREDIENT OF
    BAYER ® LOW DOSE ASPIRIN*

    LOW DOSE
    Aspirin

    • Aspirin (NSAID) 81 mg
      Pain Reliever

    Actual Size

    60 coated tablets

    Principal Display Panel - 60 Tablet Bottle Carton
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  • INGREDIENTS AND APPEARANCE
    ASSURED ASPIRIN 
    aspirin tablet, delayed release
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:68210-0015
    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
    METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    Product Characteristics
    Color yellow Score no score
    Shape ROUND Size 8mm
    Flavor Imprint Code 1
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68210-0015-6 1 in 1 CARTON 07/01/2016
    1 60 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 07/01/2016
    Labeler - SPIRIT PHARMACEUTICALS LLC (179621011)
    Establishment
    Name Address ID/FEI Business Operations
    ELYSIUM PHARMACEUTICALS LTD 915664486 manufacture(68210-0015)
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