Label: ASPIRIN- aspirin tablet

  • NDC Code(s): 49781-096-53, 49781-096-58
  • Packager: CARDINAL HEALTH
  • 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 September 27, 2014

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

  • Active ingredient (in each tablet)

    Aspirin 325mg (NSAID)*

    *nonsteroidal anti-inflammatory drug

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  • Purpose

    Pain reliever

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  • INDICATIONS & USAGE

    • Temporarily relieves minor aches and pains due to • colds • headache • muscle pain • menstrual pain • minor pains of arthritis • toothache
    • or as receommended by your doctor
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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
    • take a blood thinning (anticoagulant) or steroid drug
    • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
    • take more or for a longer time than directed
    • have had stomach ulcers or bleeding problems
    • have 3 or more alcoholic drinks every day while using this product

    Do not use 

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

    Ask a doctor before use if

    • stomach bleeding warning applies to you
    • you have a history of stomach problems, such as heartburn
    • you are taking a diuretic
    • you have asthma
    • you have high blood pressure, heart disease, liver cirrhosis or kidney disease

    Ask a doctor or pharmacist before use if you are 

    taking a prescription drug for

    • gout
    • diabetes
    • arthritis

    Stop use and ask a doctor if

    • an allergic reaction occurs. Seek medical help right away.
    • 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 
    • redness or swelling is present 
    • any new symptoms occur 
    • ringing in the ears or loss of hearing occurs 
     These could be signs of a serious illness.

    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 accidental 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 to 2 tablets every 4 hours while symptoms persist. Do not exceed 12 tablets in 24 hours unless diretced by a physician. 
     children under 12 years  consult a physician

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  • Other information

    • avoid excess heat and moisture
    • store below 250 C (770 F)
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  • Inactive ingredients

    croscarmellose sodium, D&C yellow #10 Lake, FD&C red #6, hypromellose, methacrylic acid copolymer, microcrystalline cellulose, polyethylene glycol, propylene glycol, sodium lauryl sulfate, starch, stearic acid, talc, titanium dioxide, triacetin. 

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  • Questions or comments?

    Adverse drug event call: 1-866-562-2756 

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  • PRINCIPAL DISPLAY PANEL

    Compare to Ecotrin® active ingredient

    Leader 

    Regular Strength Aspirin

    Enteric Coated Aspirin 325 mg

    Pain Reliever (NSAID)

    image of label

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  • INGREDIENTS AND APPEARANCE
    ASPIRIN 
    aspirin tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:49781-096
    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
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    D&C RED NO. 6 (UNII: 481744AI4O)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    Product Characteristics
    Color orange Score no score
    Shape ROUND Size 10mm
    Flavor Imprint Code PH024
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:49781-096-53 1 in 1 CARTON
    1 125 in 1 BOTTLE
    2 NDC:49781-096-58 300 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part343 09/20/2014
    Labeler - CARDINAL HEALTH (097537435)
    Registrant - Pharbest Pharmaceuticals, Inc. (557054835)
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