Label: CHEWABLE ASPIRIN LOW DOSE- aspirin tablet

  • NDC Code(s): 63868-029-36
  • Packager: CHAIN DRUG MARKETING ASSOCIATION INC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 15, 2018

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
    • 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
    • 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 a blood thinning (anticoagulant) or steroid drug
    • 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
    • if you have ever had an allergic reaction to this product or any of its ingredients

    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

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

    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, 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

    corn starch, D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrates hydrated, flavor, maltodextrin, sucralose

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  • Principal Display Panel

    QC®
    QUALITY
    CHOICE

    NDC 63868-029-36

    Compare to the active ingredient
    in BAYER® CHEWABLE
    LOW DOSE ASPIRIN

    Low Dose
    Chewable Aspirin

    Aspirin 81 mg

    Pain Reliever (NSAID)
    Chewable | Aspirin Regimen**

    Cherry
    Flavor

    36 Tablets

    Actual Size

    **Talk to your doctor or other healthcare provider
    before using this product for your heart.

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

    100% QC
    SATISFACTION
    GUARANTEED

    Distributed by C.D.M.A., Inc.©
    43157 W 9 Mile Rd
    Novi, MI 48376
    www.qualitychoice.com
    Questions: 248-449-9300

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

    50844           ORG041839707

    44-397A

    44-397A

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  • INGREDIENTS AND APPEARANCE
    CHEWABLE ASPIRIN  LOW DOSE
    aspirin tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:63868-029
    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)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    DEXTRATES (UNII: G263MI44RU)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    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:63868-029-36 1 in 1 CARTON 09/04/2001
    1 36 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part343 09/04/2001
    Labeler - CHAIN DRUG MARKETING ASSOCIATION INC (011920774)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 038154464 PACK(63868-029)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 832867894 MANUFACTURE(63868-029)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 967626305 PACK(63868-029)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 868734088 PACK(63868-029)
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