Label: ASPIRIN- aspirin tablet

  • NDC Code(s): 57896-109-25
  • Packager: Geri-Care Pharmaceuticals, Corp
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated September 20, 2017

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

  • Active ingredient

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

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  • Purposes

    Pain reliever/fever reducer

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  • Uses

    temporarily relieves minor aches and pains due to:

    • headache
    • muscular aches
    • minor pain of arthritis
    • backache
    • the common cold
    • toothache
    • premenstrual and menstrual cramps
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  • 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 a blood thinning (anticoagulant) or steroid drug
    • 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 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 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

    • 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
    • an allergic reaction occurs.  Seek medical help right away.
    • new symptoms occur
    • ringing in the ears or 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

    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 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.

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  • Directions

    • drink a full glass of water with each dose
    • adults and children 12 years and over: take 1 to 2 tablets every 4 hours while symptoms last. Do not take more than 12 tablets in 24 hours unless directed by a doctor
    • children under 12 years: do not use unless directed by a doctor
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  • Other information

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

    corn starch

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  • Questions or comments?

    1-800-540-3765

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  • Principal Display Panel​​

    NDC 57896-901-25

    HEALTH ★STAR
    THE SENSIBLE CHOICE
    FOR PRICE AND HEALTH

    ASPIRIN
    (NSAID)    
    325 mg

    Fast, Safe, Effective
    Pain Relief

    COMPARE TO THE ACTIVE INGREDIENT OF BAYER® ASPIRIN**

    250 Tablets

    **This product is not manufactured or distributed by Bayer HealthCare LLC, owner of the registered trademark Bayer® Aspirin.
    50844    ORG011324913

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

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

    Health Star 44-249

    Health Star 44-249

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  • INGREDIENTS AND APPEARANCE
    ASPIRIN 
    aspirin tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:57896-109
    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)  
    Product Characteristics
    Color WHITE Score no score
    Shape ROUND Size 11mm
    Flavor Imprint Code 44;249
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:57896-109-25 250 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/04/1993 12/30/2018
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part343 08/04/1993 12/30/2018
    Labeler - Geri-Care Pharmaceuticals, Corp (611196254)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 038154464 PACK(57896-109)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 832867894 MANUFACTURE(57896-109)
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