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 July 7, 2011

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  • Active ingredient (in each tablet)

    Aspirin 325 mg (NSAID)

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  • Purpose

    Pain reliever/fever reducer

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  • Uses

    For the temporary relief  of minor aches and pains associated with:

    • a cold
    • headache
    • toothache
    • muscular aches
    • backache
    • premenstrual and menstrual cramps
    • minor pain from arthritis
    • and to reduce fever
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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 a nonsteroidal anti-inflammatory drug (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 steroid drug
    • take other drugs containing a prescription or nonprescription NSAID (aspirin, ibuprofen, naproxen, or others)
    • have 3 or more alcoholic drinks every day while using this product
    • take more or for longer time than directed

    Do not use

    • if you have ever had an allergic reaction to any other pain reliever/fever reducer
    • if you are allergic to aspirin

    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

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

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

    Stop use and ask a doctor if

    • you experience any of the following signs of stomach bleeding
    • feel faint
    • vomit blood
    • have bloody stools or black stools
    • have stomach pain that does not get better
    These could be signs of a serious condition.

    If pregnant or breast-feeding,

    ask a health professional before use. It is especially important not to use aspirin during the last three months of pregnancy unless specifically 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 with water every 4  hours while symptoms persist. Not more than 12 tablets in 24 hours
    • children under 12 years: consult a doctor
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  • Other information

    • store at room temperature, 15 -30° C (59-86° F)
    • do not use if tamper proof seal is open or missing.
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  • Inactive ingredients

    microcrystalline cellulose, corn starch and croscarmellose sodium.

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  • Questions or comments

    877-921-7873

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  • Front label
  • Back label
  • INGREDIENTS AND APPEARANCE
    ASPIRIN 
    aspirin tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:59088-120
    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
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    Product Characteristics
    Color white Score no score
    Shape ROUND Size 10mm
    Flavor Imprint Code P120
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59088-120-59 100 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part343 07/07/2011
    Labeler - PureTek Corporation (785961046)
    Establishment
    Name Address ID/FEI Business Operations
    PureTek Corporation 785961046 manufacture, label, pack, outsourcing human drug compounding, repack, relabel
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