Label: ASPIRIN CHEWABLE LOW DOSE- aspirin tablet, chewable

  • 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 November 3, 2021

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

  • Active ingredient (in each chewable tablet)

    Aspirin 81 mg (NSAID)*
    *nonsteroidal anti-inflammatory drug

  • Purpose

    Pain reliever

  • Uses

    for the temporary relief of minor aches and pains or as recommended by your doctor

  • 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:

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

    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.

  • Directions

    • drink a full glass of water with each dose
    • chew or crush tablets completely before swallowing; do not swallow tablets whole
    • adults and children 12 years and over: take 4 to 8 chewable tablets every 4 hours not to exceed 48 chewable tablets in 24 hours unless directed by a doctor
    • children under 12 years: do not use unless directed by a doctor
  • Other information

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

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

  • Questions or comments?

    1-800-426-9391

  • Principal Display Panel

    Premier
    Value® 

    COMPARE TO THE ACTIVE INGREDIENT IN
    BAYER® CHEWABLE LOW DOSE ASPIRIN

    Chewable Low Dose
    Aspirin 81 mg chewable tablets
    PAIN RELIEVER (NSAID)

    Aspirin regimen**

    36 Cherry flavored
    Chewable Tablets

    Chew or crush tablets completely before swallowing.

    **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

    †This product is not manufactured or distributed
    by Bayer AG, owner of the registered trademark
    Bayer® Chewable Low Dose Aspirin.
    50844          REV1118A39707

    Distributed By: Pharmacy Value Alliance, LLC
    407 East Lancaster Avenue, Wayne. PA 19087

    If for any reason you are not satisfied with
    this product, please return it to the store
    where purchased for a full refund.

    Premier Value 44-397A

    Premier Value 44-397A

  • INGREDIENTS AND APPEARANCE
    ASPIRIN  CHEWABLE LOW DOSE
    aspirin tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-689
    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)  
    D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    DEXTROSE MONOHYDRATE (UNII: LX22YL083G)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeROUNDSize8mm
    FlavorCHERRYImprint Code 44;397
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68016-689-361 in 1 CARTON09/04/2001
    136 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34309/04/2001
    Labeler - Chain Drug Consortium (101668460)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464pack(68016-689)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894manufacture(68016-689)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305pack(68016-689)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088pack(68016-689)