LOW DOSE ASPIRIN CHEWABLE (ASPIRIN) TABLET, CHEWABLE [HEALTHLIFE OF USA]

LOW DOSE ASPIRIN CHEWABLE (ASPIRIN) TABLET, CHEWABLE [HEALTHLIFE OF USA]
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NDC 69517-136-30
Set ID cd727543-10ec-4991-8036-d4668187230b
Category HUMAN OTC DRUG LABEL
Packager Healthlife of USA
Generic Name
Product Class
Product Number
Application Number PART343
  • 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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