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Enteric Coated Aspirin (Qualitest Pharmaceuticals)

Available Formats

Dosage Form Package Information Links
TABLET 1000 TABLET in 1 BOTTLE (0603-0169-32) Label Information
TABLET 100 TABLET in 1 BOTTLE (0603-0169-21) Label Information

Complete Enteric Coated Aspirin Information

  • ACTIVE INGREDIENTS (IN EACH TABLET)

    Aspirin 325mg (NSAID*)

    *nonsteroidal anti-inflammatory drug


  • PURPOSE

    Pain reliever


  • USES

    for the 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.


  • 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
    • asthma (wheezing)
    • shock

    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 other pain relievers/fever reducers

    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:

    • anticoagulation (thinning the blood)
    • diabetes
    • gout
    • 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: feel faint, vomit blood, have bloody or black stools, have stomach pain that does not get better
    • new symptoms occur
    • redness or swelling is present
    • ringing in the ears or loss of hearing occurs
    • pain gets worse or lasts for more than 10 days

    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 specifically 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 right away.


  • DIRECTIONS

    • drink a full glass of water with each dose
    • adults and children 12 years and over: take 1 or 2 tablets every 4 hours not to exceed 12 tablets in 24 hours unless directed by a doctor
    • children under 12 years: consult a doctor

  • OTHER INFORMATION

    • store at room temperature
    • do not use if imprinted safety seal under cap is broken or missing

    You may report serious side effects to: 1-888-952-0050


  • INACTIVE INGREDIENTS

    corrn starch, croscarmellose sodium, Dimethicone, D&C Yellow # 10 aluminum lake, FD&C Yellow #6 aluminum lake, hypromellose, methacrylic acid copolymer, microcrystalline cellulose, mineral oil, polysorbate 80, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate.


  • PRINCIPAL DISPLAY PANEL

    Product Label

    Pain Reliever for Arthritis Pain

    Made in the USA for

    Qualitest Pharmaceuticals

    130 Vintage Drive, Huntsville, AL 35811

    EntericAspirin325mg100

    EntericAspirin325mg1000


  • INGREDIENTS AND APPEARANCE
    ENTERIC COATED ASPIRIN  
    regular strength tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0603-0169
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 325 mg
    Inactive Ingredients
    Ingredient Name Strength
    STARCH, CORN (UNII: O8232NY3SJ)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TALC (UNII: 7SEV7J4R1U)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    Product Characteristics
    Color orange Score no score
    Shape ROUND Size 11mm
    Flavor Imprint Code T
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0603-0169-21 100 in 1 BOTTLE
    2 NDC:0603-0169-32 1000 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part343 02/04/2011
    Labeler - Qualitest Pharmaceuticals (011103059)
    Registrant - A&Z Pharmaceutical, Inc. (926820705)
    Establishment
    Name Address ID/FEI Business Operations
    A&Z Pharmaceutical, Inc. 926820705 manufacture(0603-0169) , label(0603-0169)