Label: ASPIRIN LOW DOSE- aspirin tablet, delayed release

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 21, 2024

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  • Active ingredient (in each tablet)

    Aspirin 81 mg (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
    •
    shock
    •
    asthma (wheezing)

    Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you

    •
    take more or for a longer time than directed
    •
    take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
    •
    have had stomach ulcers or bleeding problems
    •
    have 3 or more alcoholic drinks every day while using this product
    •
    take a blood thinning (anticoagulant) or steroid drug
    •
    are age 60 or older

    Do not use

    •
    if you are allergic to aspirin or any other pain reliever/fever reducer
    •
    if you have ever had an allergic reaction to this product or any of its ingredients

    Ask a doctor before use if

    •
    stomach bleeding warning applies to you
    •
    you have asthma
    •
    you have a history of stomach problems, such as heartburn
    •
    you are taking a diuretic
    •
    you have high blood pressure, heart disease, liver cirrhosis, or kidney disease

    Ask a doctor or pharmacist before use if you are

    taking a prescription drug for

    •
    gout
    •
    diabetes
    •
    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:
    o
    vomit blood
    o
    have bloody or black stools
    o
    feel faint
    o
    have stomach pain that does not get better
    •
    ringing in the ears or a loss of hearing occurs
    •
    new symptoms occur
    •
    pain gets worse or lasts more than 10 days
    •
    fever gets worse or lasts more than 3 days
    •
    redness or swelling is present

    These could be signs of a serious condition.

    If pregnant or breast-feeding,

    ask a health professional before use. It is especially important not to use aspirin at 20 weeks or later in 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 right away.

  • Directions

    •
    do not take more than directed
    •
    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: do not use unless directed by a doctor
  • Other information

    •
    use by expiration date on package
    •
    store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • Inactive ingredients

    corn starch, D&C yellow #10, FD&C yellow #6, hypromellose, methacrylic acid, microcrystalline cellulose, polydextrose, polyethylene glycol, shellac wax, silica, simethicone, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triacetin, triethyl citrate

  • Questions or comments?

    (800) 616-2471

  • Principal Display Panel

    Major®

    Repackaged By: Preferred Pharmaceuticals Inc.

    NDC 68788-8334-1

    ASPIRIN
    Low Dose

    PAIN RELIEVER (NSAID)
    81 mg

    Enteric Coated
    Safety Coated

    Actual Size

    1000 Tablets

    Compare to the active
    ingredient in Bayer®
    Low Dose Aspirin†

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED
    SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

    †This product is not manufactured or
    distributed by Bayer AG, owner of the
    registered trademark Bayer® Low Dose
    Aspirin. 50844 REV0122A60016
    Repackaged By: Preferred Pharmaceuticals Inc.

    MAJOR® PHARMACEUTICALS
    17177 N Laurel Park Drive, Suite 233
    Livonia, MI 48152 USA M-17
    Rev. 05/18 Re-order No. 700939

    Timeline Description automatically generated

    major 44-600A

  • INGREDIENTS AND APPEARANCE
    ASPIRIN  LOW DOSE
    aspirin tablet, delayed release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68788-8334(NDC:0904-6751)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN81 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    METHACRYLIC ACID (UNII: 1CS02G8656)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SHELLAC (UNII: 46N107B71O)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    Product Characteristics
    ColoryellowScoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code L
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68788-8334-1100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/23/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug34301/23/2023
    Labeler - Preferred Pharmaceuticals Inc. (791119022)
    Registrant - Preferred Pharmaceuticals Inc. (791119022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Preferred Pharmaceuticals Inc.791119022REPACK(68788-8334)
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