Label: ASPIRIN - aspirin tablet

  • 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 23, 2011

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  • Active ingredient(in each tablet)

    Aspirin 325mg

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  • Purposes

    Pain reliever/fever reducer

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  • Uses

    temporarily relieves

    • headache
    • muscle pain
    • toothache
    • menstrual pain
    • minor pain of arthritis
    • pain and fever of colds
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  • Warnings

    Reye's syndrome:Children and teenagers should not use this medicine for chicken pox or flu symptoms before a doctor is consulted about Reye's syndrome, a rare but serious illness reported to be associated with aspirin.

    Allergy alert:Aspirin may cause a severe allergic reaction which may include:
    • hives
    • shock
    • facial swelling
    • asthma (wheezing)

    Alcohol warning:

    If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take aspirin or other pain reliever/fever reducers. Aspirin may cause stomach bleeding.

    Do not use

    if you are allergic to aspirin or any other pain reliever/fever reducer

    Ask a doctor before use if you have

    • stomach problems (such as heartburn, upset stomach, or stomach pain) that last or come back
    • bleeding problems
    • ulcers
    • asthma

    Ask a doctor or pharmacist before use if you are

    taking a prescription drug for

    • anticoagulation (blood thinning)
    • gout
    • diabetes
    • arthritis

    Stop use and ask a doctor if

    • 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
    • fever lasts more than 3 days
    • 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 1 or 2 tablets every 4 hours or 3 tablets every 6 hours, not to exceed 12 tablets in 24 hours
    • children under 12 years: consult a doctor
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  • Other information

    • save carton for full directions and warnings
    • store at room temperature
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  • Inactive ingredients

    dry starch, citric acid, carboxymethyl starch sodium, starch, starch paste

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  • PRINCIPAL DISPLAY PANEL

    Aspirinimage of bottle label

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  • INGREDIENTS AND APPEARANCE
    ASPIRIN 
    aspirin tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:67510-0008
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 325 mg
    Inactive Ingredients
    Ingredient Name Strength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    Color white Score no score
    Shape ROUND Size 10mm
    Flavor Imprint Code ASPIRIN
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:67510-0008-1 100 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part343 11/23/2011
    Labeler - Kareway Product, Inc. (121840057)
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