Label: LEADER LOW DOSE ASPIRIN- aspirin tablet, chewable

  • 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 30, 2014

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  • Active ingredient (in each tablet)

    Aspirin 81mg (NSAID)*

    *nonsteroidal anti-inflammatory drug

  • Purpose

    Pain reliever

  • INDICATIONS & USAGE

    • for the temporary relief of minor aches and pains or as recommneded by your doctor
    • ask your doctor about other uses for this product
  • Warning

    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

    • facial swelling
    • shock
    • hives
    • 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)
    • 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
    • take more or for a longer time than directed

    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

    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

    • 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
    • any new symptoms occur
    • pain gets worse or lasts more than 10 days
    • redness or swelling is present
    • 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 (1-800-222-1222) right away.

  • 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

  • Other information

    • store at room temperature (150-300C)
    • aviod excess heat and moisture
  • Inactive ingredients

    Corn starch, dextrose monohydrate, FD&c yellow #6, flavor, silicon dioxide, sodium saccharine and stearic acid

  • Questions or comments?

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

  • PRINCIPAL DISPLAY PANEL

    Compare to Bayer® Chewable Low Dose Aspirin active ingredient***

    Leader

    Low Dose

    Aspirin

    81 mg

    Chewable Orange

    Pain Reliever (NSAID)

    Orange Flavored

    image of label

  • INGREDIENTS AND APPEARANCE
    LEADER LOW DOSE ASPIRIN 
    aspirin tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49781-084
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN81 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    DEXTROSE MONOHYDRATE (UNII: LX22YL083G)  
    Product Characteristics
    ColororangeScoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code PH034
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49781-084-991000 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34309/20/2014
    Labeler - CARDINAL HEALTH (097537435)
    Registrant - Pharbest Pharmaceuticals, Inc. (557054835)
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