Label: BUFFERED ASPIRIN- aspirin tablet, film coated

  • NDC Code(s): 70000-0147-1
  • Packager: Cardinal Health 110, LLC. DBA Leader
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated April 22, 2023

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  • Active ingredient (in each tablet)

    Buffered aspirin equal to 325 mg aspirin (NSAID)*
    (buffered with calcium carbonate, magnesium carbonate, and magnesium oxide)
    *nonsteroidal anti-inflammatory drug

  • Purpose

    Pain reliever/fever reducer 

  • Uses

    • temporarily relieves minor aches and pains associated with:
      • toothache
      • minor pain of arthritis
      • backache
      • the common cold
      • headache
      • muscular aches
      • premenstrual & menstrual cramps
    • temporarily reduces fever
  • 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:

    • shock
    • hives
    • asthma (wheezing)
    • facial swelling

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

    • have had stomach ulcers or bleeding problems
    • have 3 or more alcoholic drinks every day while using this product
    • 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]
    • 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
    • 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 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:
      • feel faint
      • vomit blood
      • have bloody or black stools
      • have stomach pain that does not get better
    • 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 2 tablets every 4 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

    • each tablet contains: calcium 35 mg and magnesium 45 mg
    • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
    • see end flap for expiration date and lot number
  • Inactive ingredients

    anhydrous citric acid, corn starch, dibasic sodium phosphate anhydrous, hydrogenated vegetable oil, hypromellose, microcrystalline cellulose, polyethylene glycol, propylene glycol, shellac wax, simethicone, sodium lauryl sulfate, talc, titanium dioxide

  • Questions or comments?

    1-800-426-9391

  • Principal display panel

    Leader™

    NDC 70000-0147-1

    Buffered Aspirin
    Tri-Buffered Aspirin, 325 mg Tablets
    Pain Reliever / Fever Reducer (NSAID)

    130
    COATED
    TABLETS

    ACTUAL SIZE

    COMPARE TO
    BUFFERIN®
    active ingredient†

    100% Money Back Guarantee

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

    CIN 5285770          REV. 4/22

    †This product is not manufactured or distributed by Genomma Lab
    USA, Inc., owner of the registered trademark Bufferin®.
    50844     REV0122B18330

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

    All LEADERTM Brand
    Products Have A
    100%
    Money Back
    Guarantee

    © 2022 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 44-183

    Leader 44-183

  • INGREDIENTS AND APPEARANCE
    BUFFERED ASPIRIN 
    aspirin tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0147
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    HYDROGENATED COTTONSEED OIL (UNII: Z82Y2C65EA)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHELLAC (UNII: 46N107B71O)  
    DIMETHICONE 410 (UNII: TYU5GP6XGE)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code 44;183
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0147-11 in 1 CARTON03/30/1990
    1130 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01303/30/1990
    Labeler - Cardinal Health 110, LLC. DBA Leader (063997360)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464pack(70000-0147)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837manufacture(70000-0147)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894manufacture(70000-0147)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305pack(70000-0147)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.117025878manufacture(70000-0147)
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