Label: ASPIRIN- aspirin tablet, chewable

  • 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 July 13, 2016

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
    • ask your doctor about other uses for this product
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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
    • shock
    • facial swelling
    • 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
    • take a blood thinning (anticoagulant) or steroid drug
    • take other drugs containing prescription or nonprescription NSAIDs ( aspirin, ibuprofen, naproxen, or others)
    • have had stomach ulcers or bleeding problems
    • have 3 or more alcoholic drinks every day while using this product
    • take more or for a longer time than directed

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  • DO NOT USE

    Do not use

    • if you are allergic to aspirin or any other pain reliever/fever reducer
    • this product for at least 7 days after tonsillectomy or oral surgery unless directed by a doctor
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  • ASK DOCTOR

    Ask a doctor before use if

    • the 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
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  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are taking a prescription drug for

    • gout
    • diabetes
    • arthritis
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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
    • an allergic reaction occurs. Seek medical help right away.
    • any new symptoms occur
    • ringing in the ears or a 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 illness.

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  • 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 complications during delivery.

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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

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  • OVERDOSAGE

    In case of accidental overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

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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

    • store at room temperature
    • avoid excess heat and moisture
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  • Inactive ingredients

    cherry flavor, D&C red #27 aluminum lake, dextrose anhydrous, microcrystalline cellulose, mint flavor, pregelatinized starch, saccharin sodium, talc.

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  • Questions or comments?

    1-888-341-9214

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  • INGREDIENTS AND APPEARANCE
    ASPIRIN 
    aspirin tablet, chewable
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:70000-0102
    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, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
    ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    Color red (Reddish) Score no score
    Shape ROUND Size 8mm
    Flavor CHERRY, MINT Imprint Code 029
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:70000-0102-1 1 in 1 CARTON 08/15/2016
    1 36 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 08/15/2016
    Labeler - Cardinal Health, Inc. (097537435)
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