Label: LOW DOSE ASPIRIN CHEWABLE- aspirin tablet, chewable

  • 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 October 9, 2017

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  • Drug Facts

    Active Ingredient (in each Tablet)

    Aspirin 81mg (NSAID*)

    *nonsteroidal anti-inflammatory drug

  • Purpose

    Pain Reliever

  • Uses

    • temporarily relieves minor aches and pains
    • for other uses, see your doctor, but do not use for more than 10 days without consulting your doctor because serious side effects may occur.
  • 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 behaviour 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
    • 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
  • 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
    • 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
  • Other information

    • TAMPER EVIDENT: DO NOT USE THIS PRODUCT IF THE IMPRINTED FOIL SEAL OVER THE MOUTH OF THE BOTTLE IS CUT, TORN, BROKEN OR MISSING
    • store at 25°C (77°F); excursion permitted between 15°-30°C (59°-86°F)
    • use by expiration date on package
  • Inactive Ingredients

    • Butylated Hydroxytoluene
    • Dextrates
    • FD&C Yellow No.6
    • Cellulose, Microcrystalline
    • Corn Starch
    • Orange
    • Modified corn starch
    • Saccharin soidum 
    • Stearic acid 
  • Principal Display Panel

    Low Dose

    ASPIRIN 81mg

    30 Chewable Tablets 

    image description

  • INGREDIENTS AND APPEARANCE
    LOW DOSE ASPIRIN CHEWABLE 
    aspirin tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69517-136
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN81 mg
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    DEXTRATES (UNII: G263MI44RU)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) (UNII: 461P5CJN6T)  
    ORANGE (UNII: 5EVU04N5QU)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColororangeScoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code TCL;334
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69517-136-3030 in 1 BOTTLE; Type 0: Not a Combination Product10/09/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34310/09/2017
    Labeler - Healthlife of USA (079656178)
    Establishment
    NameAddressID/FEIBusiness Operations
    Time-Cap Labs, Inc.037052099manufacture(69517-136)
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