PAIN RELIEVER (ASPIRIN 81 MG) TABLET, DELAYED RELEASE [HEALTHLIFE OF USA]

PAIN RELIEVER (ASPIRIN 81 MG) TABLET, DELAYED RELEASE [HEALTHLIFE OF USA]
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NDC 69517-104-01, 69517-104-02, 69517-104-25, 69517-104-30, 69517-104-50, 69517-104-60, 69517-104-65
Set ID f0ce670a-179a-462c-ad4f-02129c456ffb
Category HUMAN OTC DRUG LABEL
Packager HealthLife Of USA
Generic Name
Product Class
Product Number
Application Number PART343
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredients (in each tablet)                          Purpose

    Aspirin 81 mg (NSAID)* ........................................ Pain reliever

    *nonsteroidal anti-inflammatory drug

  • Uses

    • temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief.
    • ask your doctor about other uses for 81 mg Aspirin
  • 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
    • shock
    • facial swelling
    • 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

    Do not use

    • if you are allergic to aspirin or any other pain reliever/fever reducer

    Ask a doctor before use if

    • you have asthma
    • 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 are taking a diuretic

    Ask a doctor or pharmacist before use if you are

    • taking a prescription drug for diabetes, gout, or arthritis
    • under a doctor's care for any serious condition
    • taking any other drug

    Stop use and ask a doctor if

    • you experience any of the following signs of stomach bleeding:
    • feel faint
    • have bloody or black stools
    • vomit blood
    • have stomach pain that does not get better
    • an allergic reaction occurs.

       Seek medical help right away.

    • ringing in the ears or loss of hearing occurs
    • pain gets worse or lasts for more than 10 days
    • fever gets worse or lasts for more than 3 days
    • redness or swelling present in the painful area
    • new symptoms occur

    These could be sign 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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • 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

    • store at room temperature 15-30ºC (59-86ºF)
    • read all product information before using.
    • Keep this box for important information
    • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

  • Inactive ingredients

    Anhydrous Lactose, Carnuba Wax Colloidal Sillicon Dioxide, Crosscarmellose Sodium,FD&C Yellow #10 al lake, FD&C Yellow#6 al Lake, Iron Oxide Ochre, Methacrylic acid copolymer, Micro crystalline cellulose, Polysorbate 80, simethiocone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate

  • Questions or comments?

    Call toll free 1-844-832-1138 Monday through Friday 9AM – 5PM EST or www.healthlifeofusa.com

  • PRINCIPAL DISPLAY PANEL

    See New Warnings Information & Directions

    Compare to Bayer® Low Dose Aspirin active ingredients†

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

    Aspirin Delayed Release Tablets, 81 mg

    Principal Display Panel

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEVER 
    aspirin 81 mg tablet, delayed release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69517-104
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN81 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    BROWN IRON OXIDE (UNII: 1N032N7MFO)  
    METHACRYLIC ACID (UNII: 1CS02G8656)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TALC (UNII: 7SEV7J4R1U)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    Product Characteristics
    ColoryellowScoreno score
    ShapeROUNDSize7mm
    FlavorImprint Code A
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69517-104-2525 in 1 BOX06/05/2017
    12 in 1 POUCH; Type 0: Not a Combination Product
    2NDC:69517-104-5050 in 1 BOX06/05/2017
    22 in 1 POUCH; Type 0: Not a Combination Product
    3NDC:69517-104-022 in 1 POUCH06/05/2017
    32 in 1 POUCH; Type 0: Not a Combination Product
    4NDC:69517-104-011000 in 1 BOTTLE06/05/2017
    4NDC:69517-104-65365 in 1 BOTTLE
    4NDC:69517-104-3030 in 1 BOTTLE
    41 in 1 CARTON; Type 0: Not a Combination Product
    5NDC:69517-104-601 in 1 CARTON06/05/2017
    560 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34302/09/2016
    Labeler - HealthLife Of USA (079656178)
    Establishment
    NameAddressID/FEIBusiness Operations
    Elysium Pharmaceutical Ltd.915664486manufacture(69517-104)

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