Label: ASPIRIN- aspirin tablet

  • NDC Code(s): 65923-249-12
  • Packager: United Exchange Corporation
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 March 16, 2018

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

  • Active ingredient (in each tablet)

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

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  • Purpose

    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 of 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

    • gout
    • diabetes
    • arthritis

    Stop use and ask a doctor if

    • you experience any of the following signs of stomach bleeding:
      • have bloody or black stools
      • feel faint
      • vomit blood
      • have stomach pain that does not get better
    • an allergic reaction occurs. Seek medical help right away
    • 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
    • new symptoms occur

    These could be signs of a serious condition.

    If pregnant or breast-feeding,

    ask a health professional before use. It is 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 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
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  • Inactive ingredient

    corn starch

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  • Questions or comments?

    1-800-426-9391 Close
  • Principal display panel

    †Compare to the Active Ingredient in Genuine Bayer®

    ASPIRIN
    (NSAID)

    Pain Reliever • Fever Reducer

    For the temporary relief from the pain of:
    • headache • muscle pain • toothache
    • menstrual pain • pain and fever of colds
    • minor pain of arthritis

    100 TABLETS

    Actual Size 

    325 mg each

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

    †This product is not manufactured o distributed by Bayer HealthCare LLC, owner of the registered trademark Genuine Bayer® Aspirin.

    50844 ORG011324912

    Distributed By:

    UNITED EXCHANGE CORP.
    172111 Valley View Ave. Cerritos, CA 90703

    United Exchange 44-249

    United Exchange 44-249


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  • INGREDIENTS AND APPEARANCE
    ASPIRIN 
    aspirin tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:65923-249
    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 10mm
    Flavor Imprint Code 44;249
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:65923-249-12 100 in 1 BOTTLE; Type 0: Not a Combination Product 08/04/1993
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part343 08/04/1993
    Labeler - United Exchange Corporation (840130579)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 038154464 PACK(65923-249)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 832867837 MANUFACTURE(65923-249)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 967626305 PACK(65923-249)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 868734088 PACK(65923-249)
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