Label: ASPIRIN 81 MG- aspirin tablet, chewable

  • NDC Code(s): 69618-014-36
  • 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 March 16, 2016

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

  • SPL UNCLASSIFIED SECTION

    Drugs Facts

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  • Active ingredients (in each tablet)

    Aspirin USP 81 mg (NSAID)*

    *nonsterodial anti-inflammatory drug

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  • Purpose

    Pain reliever

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  • Uses

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

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  • SPL UNCLASSIFIED SECTION

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

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

    Stomach bleeding warning: This product contains an NSID, 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

    Drug Facts continued on back of label

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  • DO NOT USE

    Do not use

    • if you have ever had an allergic reaction to any other pain reliever/fever reducer
    • for at least 7 days after tonsillectomy or oral surgery
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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
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  • 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 serious condition
    • taking any other drug
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  • STOP USE

    Stop use and ask a doctor if

    • 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
    • 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 ears or loss of hearing occurs

    These could be sings of a serious condition

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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. Incase 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 & 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
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  • Other infomation

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

    compressible sugar, corn starch, FD&C yellow #6 alum. lake, magnesium stearate, orange flavor, silicon dioxide

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  • Questions or comments?

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

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  • SPL UNCLASSIFIED SECTION

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

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  • SPL UNCLASSIFIED SECTION

    *Reliable 1 Laboratories LLC is not affiliated with the owner of the trademark BAYER®.

    Distributed by: Reliable 1 Laboratories LLC, Valley Stream, NY 11580

    www.reliable1labs.com

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  • PRINCIPAL DISPLAY PANEL

    NDC 69618-014-36

    ORANGE FLAVORED

    Aspirin USP 81 mg (NSAID)

    Adult Low Strength

    PAIN RELIEVER

    36 CHEWABLE TABLETS

    *Compare to Active Ingredient in Aspirin Regimen BAYER® Chewable

    Aspirin 81 mg chew

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  • INGREDIENTS AND APPEARANCE
    ASPIRIN 81 MG 
    aspirin tablet, chewable
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:69618-014
    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
    STARCH, CORN (UNII: O8232NY3SJ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SUCROSE (UNII: C151H8M554)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    ORANGE (UNII: 5EVU04N5QU)  
    Product Characteristics
    Color orange Score no score
    Shape ROUND Size 8mm
    Flavor ORANGE Imprint Code AP;009
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:69618-014-36 36 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)
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