Label: ASPIRIN 81 MG ENTERIC COATED- aspirin tablet

  • NDC Code(s): 69618-017-02, 69618-017-10
  • 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 November 1, 2015

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

    Close
  • Active ingredient (in each tablet)

    Aspirin USP, 81 mg (NSAID)*

    *nonsteroidal anti-inflammatory drug

    Close
  • Purpose

    Pain reliever

    Close
  • Uses

    • temporarily relieves minor aches and pains
    • for other uses, see your doctor, but do not use for more than 10 days without consulting you doctor because serious side effects may occur.
    Close
  • 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 comiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

    Close
  • OTHER SAFETY INFORMATION

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

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

    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 steriod drug
    • take other drugs containing prescription or non-prescription NSAIDs (ibuprofen, naproxen, or others)
    • take more or for a longer time than directed
    • have 3 or more alcoholic drinks every day while using this product
    Close
  • DO NOT USE

    Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer

    Drug Facts continued on back of label

    Close
  • 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
    Close
  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are

    • taking a prescription drug for diabetes, gout or arthritis
    • under a doctor's care for any s
    Close
  • STOP USE

    Stop use and ask a doctor if

    • you experience any of the following signs of stomach bleeding:
    • feel faint
    • vomit blood
    • have stomach pain that does not get better
    • pain gets worse or lasts more than 10 days
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present in the painful area
    • any new symptoms appear
    • ringing in the ear or loss of hearing occurs

    these could be sings of a serious condition

    Close
  • PREGNANCY OR BREAST FEEDING

    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 complictions during delivery.

    Close
  • 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.

    Close
  • Directions

    DRINK A FULL GLASS OF WATER WITH EACH DOSE

    • adults and children 12 years & older: take 4 to 8 tablets every 4 hours while symptoms last, but not more than 48 tablets in 24 hours
    • children under 12 years: ask a doctor
    Close
  • Other information

    • store at room temperature 15°-30°C (59°-86°F)
    Close
  • INACTIVE INGREDIENT

    croscarmellose sodium, D&C yellow #10 (Al-lake), HPMC, methacrylic acid copolymer, microcrystalline cellulose, polyethylene glycol, propylene glycol, povidone, silicon dioxide, sodium lauryl sulfate, corn strach, stearic acid, talc, titanium dioxide

    Close
  • Questions or comments?

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

    Close
  • PRINCIPAL DISPLAY PANEL

    NDC 69618-017-02

    Enteric Coated

    Aspirin USP 81 mg (NSAID)

    Adult Low Strength

    PAIN RELIEVER

    120 TABLETS

    *Compare to Active Ingredient in Aspirin Regimen BAYER®

    ASPIRIN 81 MG EC TABLET - 120

    Close
  • INGREDIENTS AND APPEARANCE
    ASPIRIN 81 MG ENTERIC COATED 
    aspirin tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:69618-017
    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
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    METHACRYLIC ACID (UNII: 1CS02G8656)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TALC (UNII: 7SEV7J4R1U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    POVIDONE (UNII: FZ989GH94E)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    Product Characteristics
    Color yellow Score no score
    Shape ROUND Size 8mm
    Flavor Imprint Code AP;121
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:69618-017-02 120 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/01/2015
    2 NDC:69618-017-10 1000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/01/2015
    Image of Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part343 11/01/2015
    Labeler - Reliable 1 Laboratories LLC (079718111)
    Close