Label: CHEWABLE ASPIRIN- aspirin tablet, chewable

  • NDC Code(s): 63941-397-07
  • Packager: VALUE MERCHANDISERS COMPANY, INC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 01/14

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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  • Use

    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 teenagerswho 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 syndrom, 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:

    • have had stomach ulcers or bleeding problems
    • take a blood thinning (anticoagulant) or steroid drug
    • are age 60 or older
    • have 3 or more alcoholic drinks every day while using this product
    • take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
    • 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
    • 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 have asthma
    • you are taking a diuretic 

    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
      • have bloody or black stools
      • vomit blood
      • have stomach pain that does not get better
    • an allergic reaction occurs. Seek medical help right away.
    • new symptoms occur
    • ringing in the ears or loss of hearing occurs
    • pain gets worse or lasts more than 10 days
    • redness or swelling is present

    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 aspiring 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, get medical help or contact a Poison Control Center (1-800-222-1222) 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: do not use unless directed by a doctor 
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  • Other information

    • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
    • see end flap for expiration date and lot number 
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  • Inactive ingredients

    cherry flavor, corn starch, D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrates, sodium saccharin

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  • Principal Display Panel

    COMPARE TO ACTIVE INGREDIENT OF BAYER® CHEWABLE LOW DOSE ASPIRIN†

    Best Choice®

    CHEWABLE LOW DOSE
    Aspirin 81 mg
    Pain Reliever (NSAID)

    Low Dose Chewable Aspirin
    CHERRY FLAVOR

    36 Tablets - 81 mg each

    †This product is not manufactured or distributed by Bayer HealthCare LLC, owner of the registered trademark Bayer® Chewable Low Dose Aspirin.
    50844        REV0613B39707

    PROUDLY DISTRIBUTED BY:
    VALU MERCHANDISERS, CO.
    KANSAS CITY, KS 66106

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

    Best Choice 44-397

    Best Choice 44-397

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  • INGREDIENTS AND APPEARANCE
    CHEWABLE ASPIRIN 
    aspirin tablet, chewable
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:63941-397
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ASPIRIN (ASPIRIN) ASPIRIN 81 mg
    Inactive Ingredients
    Ingredient Name Strength
    D&C RED NO. 27  
    D&C RED NO. 30  
    DEXTRATES  
    Product Characteristics
    Color PINK Score no score
    Shape ROUND Size 8mm
    Flavor CHERRY Imprint Code 44;397
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:63941-397-07 1 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 NOT FINAL part356 09/04/2001
    Labeler - VALUE MERCHANDISERS COMPANY, INC. (868703513)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 038154464 PACK(63941-397)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 832867894 MANUFACTURE(63941-397)
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