Label: CHEWABLE ADULT LOW DOSE ASPIRIN- aspirin tablet, chewable

  • NDC Code(s): 68163-081-91
  • Packager: Raritan Pharmaceuticals Inc
  • 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 June 3, 2013

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

  • Active ingredient (in each tablet)

    Aspirin 81 mg (NSAID)*

    *nonsteroidal anti-inflammatory drug

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  • Purpose

    Pain reliever

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  • Uses

    for the temporary relief of minor aches and pains or as recommended 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 an NSAID, which may cause severe stomach bleeding. The chance is higher if you:

     
    are age 60 or over
     
    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

     
    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 have high blood pressure, heart disease, liver cirrhosis or kidney disease
     
    you are taking a diuretic
     
    you have asthma

    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
     
    new symptoms occur
     
    ringing in the ears or loss of hearing occurs

    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 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, 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 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
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  • Other information

     
    store at room temperature
     
    see end flap for expiration date and lot number
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  • Inactive ingredients

    corn starch, dextrose, FD&C yellow #6 aluminum lake, flavors, maltodextrin, sucralose.

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  • Principal Display Panel

    DRxChoice

    compare to Bayer® Chewable Low Dose Aspirin active ingredients**

    NDC 68163-081-91

    low dose

    CHEWABLE ASPIRIN
    81 mg tablets

    pain reliever (NSAID)
    orange flavor
    aspirin regimen

    36 Chewable Tablets

    3 bottles - 36 tablets each  

    value pack

    DO NOT USE IF PRINTED SEAL UNDER CAP IS BROKEN OR MISSING

    **This product is not manufactured or distributed by Bayer HealthCare LLC, owner of the registered trademark Bayer® Chewable Low Dose Aspirin.

    GLUTEN-FREE (less than 20ppm gluten. If you have specific dietary needs you should consult a doctor before consuming this product.

    Distributed By:

    Raritan Pharmaceuticals Inc

    8 Joanna Court

    DRChoice Low Dose Chewable Aspirin 3x36ct Value Pack
    DRChoice Low Dose Chewable Aspirin 3x36ct Value Pack
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  • INGREDIENTS AND APPEARANCE
    CHEWABLE ADULT LOW DOSE ASPIRIN 
    aspirin tablet, chewable
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:68163-081
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 81 mg
    Inactive Ingredients
    Ingredient Name Strength
    STARCH, CORN (UNII: O8232NY3SJ)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    Color ORANGE Score no score
    Shape ROUND Size 8mm
    Flavor ORANGE Imprint Code RP81
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68163-081-91 3 in 1 CARTON
    1 36 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part343 06/03/2013
    Labeler - Raritan Pharmaceuticals Inc (127602287)
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