Label: ASPIRIN tablet, coated

  • Category: HUMAN OTC DRUG LABEL

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 5, 2013

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • ACTIVE INGREDIENT

    Each tablet contains Aspirin 325 mg

  • INACTIVE INGREDIENT

    corn starch, croscarmellose sodium, Hypromellose, microcrystalline cellulose, mineral oil, titanium dioxide

  • 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
    You have not been drinking fluids
    You have lost a lot of fluid due to vomiting or diarrhea


  • WARNINGS


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


  • DO NOT USE

    Do not use

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

  • DOSAGE & ADMINISTRATION

    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 last

    Do not take more than 12 tablets in 24 hours unless directed by a doctor.

    Children under 12 years: consult a doctor

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the reach of children.  In case of overdose, get medical help or contact a Poison Control Center right away.

  • PURPOSE

    Pain Reliever

  • INDICATIONS & USAGE

    Uses:

    For the temporary relief of minor aches and pains due to:

    headache, colds, muscle pain, menstrual pain, toothache, minor pain of arthritis or as directed by your doctor.

    Repackaged By :
    Aidarex Pharmaceuticals LLC,
    Corona, CA 92880

  • PRINCIPAL DISPLAY PANEL

    IMAGE LABEL 

  • INGREDIENTS AND APPEARANCE
    ASPIRIN 
    aspirin tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0440-1130(NDC:49483-011)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 ng
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code TCL011
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0440-1130-9090 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34304/18/2012
    Labeler - Liberty Pharmaceuticals, Inc. (012568840)