Label: ASPIRIN- aspirin tablet, film coated

  • NDC Code(s): 70000-0253-1, 70000-0253-2, 70000-0253-3
  • Packager: Cardinal Health
  • 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 August 21, 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:

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

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

    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 a history of stomach problems, such as heartburn
    • you have asthma
    • 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:
      • 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
    • pain gets worse or lasts more than 10 days
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present
    • ringing in the ears or loss of hearing occurs

    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 or 2 tablets every 4 hours or 3 tablets every 6 hours, not to exceed 12 tablets in 24 hours
    • children under 12 years: ask a doctor
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  • Other information

    • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
    • see end flap for expiration date and lot number
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  • Inactive ingredients

    corn starch, hypromellose, polyethylene glycol, propylene glycol

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  • Questions or comments?

    1-800-426-9391

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  • Principal display panel

    LEADER™

    NDC 70000-0253-1

    Genuine
    Aspirin
    , 325 mg
    Pain Reliever / Fever Reducer (NSAID)

    50
    TABLETS

    COMPARE TO GENUINE
    BAYER®ASPIRIN

    active ingredient†

    100% Money Back Guarantee

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

    100% Money Back Guarantee
    Return to place of purchase if not satisfied.

    CIN 5320874 REV. 2/17

    †This product is not manufactured or distributed
    by Bayer HealthCare LLC, owner of the registered
    trademark Genuine Bayer® Aspirin.
    50844             ORG091515715

    DISTRIBUTED BY CARDINAL HEALTH
    DUBLIN, OHIO 43017
    www.myleader.com 1-800-200-6313
    Essential to Care™ since 1979

    © 2017 Cardinal Health. All Rights Reserved.
    CARDINAL HEALTH, the Cardinal Health LOGO,
    LEADER, and the Leader LOGO are trademarks
    or registered trademarks of Cardinal Health.


    Leader 44-157

    Leader 44-157


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  • INGREDIENTS AND APPEARANCE
    ASPIRIN 
    aspirin tablet, film coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:70000-0253
    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)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Product Characteristics
    Color WHITE Score no score
    Shape ROUND Size 10mm
    Flavor Imprint Code Aspirin;44;157
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:70000-0253-1 1 in 1 CARTON 02/10/1996
    1 50 in 1 BOTTLE; Type 0: Not a Combination Product
    2 NDC:70000-0253-2 100 in 1 BOTTLE; Type 0: Not a Combination Product 02/10/1996
    3 NDC:70000-0253-3 300 in 1 BOTTLE; Type 0: Not a Combination Product 02/10/1996
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part343 02/10/1996
    Labeler - Cardinal Health (097537435)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 038154464 PACK(70000-0253)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 967626305 PACK(70000-0253)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 868734088 PACK(70000-0253)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 832867837 MANUFACTURE(70000-0253)
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