Label: ASPIRIN LOW DOSE- aspirin tablet, chewable

  • NDC Code(s): 50844-219-07
  • Packager: L.N.K. International, 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 December 11, 2021

If you are a consumer or patient 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:

    • 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
    • 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 3 or more alcoholic drinks every day while using this product
    • have had stomach ulcers or bleeding problems

    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:
      • have bloody or black stools
      • feel faint
      • vomit blood
      • have stomach pain that does not get better
    • ringing in the ears or a loss of hearing occurs
    • redness or swelling is present
    • pain gets worse or lasts more than 10 days
    • 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

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

    corn starch, dextrates hydrated, FD&C yellow #6 aluminum lake, flavor, maltodextrin, sucralose

  • Questions or comments?

    1-800-426-9391

  • Principal display panel

    SOUNDBODY

    Compare to the active
    ingredient in Bayer®
    Chewable Low Dose Aspirin

    LOW DOSE
    Aspirin
    Chewable Tablets
    Pain Reliever (NSAID) 81 mg

    NDC 50844-219-07

    Aspirin Regimen**
    Chew or crush
    tablets completely
    before swallowing.

    Orange
    Flavored

    36 CHEWABLE TABLETS

    Actual Size

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

    Triple Pack 3 bottles x 36 tablets each = 108 tablets

    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         ORG111821807

    Manufactured for Big Lots Stores, Inc.
    by LNK INTERNATIONAL, INC.
    60 Arkay Drive, Hauppauge, NY 11788 USA
    V#733000   ITEM#022721807

    Sound Body 44-218A

    Sound Body 44-218A

  • INGREDIENTS AND APPEARANCE
    ASPIRIN  LOW DOSE
    aspirin tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50844-219
    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)  
    DEXTROSE MONOHYDRATE (UNII: LX22YL083G)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    Colororange (light) Scoreno score
    ShapeROUNDSize8mm
    FlavorORANGEImprint Code 44;218
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50844-219-073 in 1 CARTON01/16/2020
    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 finalpart34301/16/2020
    Labeler - L.N.K. International, Inc. (038154464)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464pack(50844-219)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894manufacture(50844-219)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088pack(50844-219)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305pack(50844-219)