Label: ASPIRIN tablet

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

Drug Label Information

Updated February 21, 2024

If you are a consumer or patient please visit this version.

  • Active ingredient (in each tablet)

    Aspirin 325 mg (NSAID)*
    *nonsteroidal anti-inflammatory drug

  • Purpose

    Pain reliever/fever reducer

  • Uses

    temporarily relieves:

    pain and fever of colds
    headache
    muscle pain
    minor pain of arthritis
    toothache
    menstrual pain
  • 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:

    facial swelling
    shock
    hives
    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
    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
    have had stomach ulcers or bleeding problems
    take a blood thinning (anticoagulant) or steroid drug

    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

    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

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

    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 1 or 2 tablets every 4 hours or 3 tablets every 6 hours, not to exceed 12 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 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • Inactive ingredient

    corn starch

  • Questions or comments?

    1-800-540-3765

  • Principal Display Panel

    NDC 68788-8256

    GERICARE

    ASPIRIN
    (NSAID) • 325 mg each

    PAIN RELIEVER / FEVER REDUCER

    COMPARE TO THE ACTIVE
    INGREDIENT OF BAYER® ASPIRIN**

    1000 TABLETS

    Actual Size

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

    50844
    REV0122D24912

    **This product is not manufactured or distributed by
    Bayer AG, owner of the registered trademark Bayer®
    Aspirin

    DISTRIBUTED BY:
    GERI-CARE PHARMACEUTICAL CORP.
    1650 63 Street, Brooklyn, NY 11204

    Repackaged By: Preferred Pharmaceuticals Inc.

    Aspirin Tablets 325mg

    Gericare 44-249

  • INGREDIENTS AND APPEARANCE
    ASPIRIN 
    aspirin tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68788-8256(NDC:57896-901)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code 44;249;ASPIRIN
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68788-8256-220 in 1 BOTTLE; Type 0: Not a Combination Product09/16/2022
    2NDC:68788-8256-1100 in 1 BOTTLE; Type 0: Not a Combination Product09/16/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug34309/16/2022
    Labeler - Preferred Pharmaceuticals Inc. (791119022)
    Registrant - Preferred Pharmaceuticals Inc. (791119022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Preferred Pharmaceuticals Inc.791119022REPACK(68788-8256)