EXTRA STRENGTH ASPIRIN TABLET [HEALTHLIFE OF USA]

EXTRA STRENGTH ASPIRIN TABLET [HEALTHLIFE OF USA]
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NDC 69517-115-60
Set ID 1118dc27-0a9e-4a48-b86c-1338bf28fecc
Category HUMAN OTC DRUG LABEL
Packager Healthlife of USA
Generic Name
Product Class
Product Number
Application Number PART343
  • Drug facts

  • Purpose

    Pain reliever/ Fever reducer

  • Active ingredient (in each tablet)

    Aspirin 325mg

  • Uses

    Temporarily relieves minor aches and pains due to:

    • headache
    • muscular aches
    • backache
    • minor pain of arthritis
    • the common cold
    • toothache
    • premenstrual and menstrual cramps
  • 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 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
    • taking any other drug or are under a doctor's care for any serious condition
  • Stop use and ask a doctor if:

    1. 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

    2.   an allergic reaction occurs.

    • seek medical help right away.

    3.   ringing in the ears or loss of hearing occurs

    4.   pain gets worse or lasts for more than 3 days

    5.   redness or swelling present

    6.   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

    • Do not take more than directed
    • Drink a full glass of water with each dose 
    • Adults and children 12 years of age and over: 
    1. take 1 to 2 tablets every 4 hours while symptoms last
    2. do not take more than 12 tablets in 24 hours unless directed by a doctor
    3. do not use for more than 10 days unless directed by a doctor
    • Children under 12 years: do not use unless directed by a doctor
  • Other Information

    • Store at controlled room temperature 25°C (77°F) excursions permitted between 15-30°C (59-86°F)
    • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
  • Inactive ingredients

    • Corn starch
    • Croscarmellose sodium
    • Hypromellose
    • Microcrystalline cellulose
    • Mineral oil
    • Titanium dioxide
  • Questions or comments?

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

  • Extra Strength Aspirin  Aspirin 325 mg 60 Tablets  Compare to Bayer® EXTRA STRENGTH active ingredients

    Distributed by:
    Healthlife of USA LLC
    Rahway
    NJ 07065
    www.healthlifeofusa.com

    image description

  • INGREDIENTS AND APPEARANCE
    EXTRA STRENGTH ASPIRIN 
    extra strength aspirin tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69517-115
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize12mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69517-115-601 in 1 CARTON05/31/2017
    160 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34305/31/2017
    Labeler - Healthlife of USA (079656178)
    Establishment
    NameAddressID/FEIBusiness Operations
    Time Cap Laboratories, Inc.037052099manufacture(69517-115) , pack(69517-115)

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