Label: BUFFERIN LOW DOSE BUFFERED ASPIRIN- aspirin tablet

  • NDC Code(s): 0067-6424-13
  • Packager: Novartis Consumer Health, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 03/11

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

  • Active ingredient (in each tablet)

    Buffered aspirin equal to 81 mg aspirin (NSAID)*

    (buffered with calcium carbonate, magnesium carbonate and magnesium oxide)

    *nonsteroidal anti-inflammatory drug

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  • Purpose

    Pain reliever

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  • Uses

    • temporarily relieves minor aches and pains or as recommended by your doctor
    • ask your doctor about other uses of buffered aspirin 81 mg
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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:

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

    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
    • have had stomach ulcers or bleeding problems
    • take a blood thinning (anticoagulant) or steroid drug
    • 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
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  • Do Not Use

    • if you have ever had an allergic reaction to aspirin or any other pain reliever/fever reducer
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  • Ask a doctor before use if

    • 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
    • you are on a magnesium-restricted diet
    • you have asthma
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  • Ask doctor or pharmacist before use if you are taking:

    • any other drug containing an NSAID (prescription or nonprescription)
    • a blood thinning (anticoagulant) or steroid drug
    • a prescription drug for diabetes, gout, or arthritis
    • any other drug, or are under a doctor’s care for any serious condition
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  • 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 loss of hearing occurs
    • painful area is red or swollen
    • pain gets worse or lasts for more than 10 days
    • fever gets worse or lasts for more than 3 days
    • any new symptoms appear
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  • 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.

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  • Keep out of reach of children
  • Overdose

    In case of overdose, get medical help or contact a Poison Control Center right away.

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  • Directions

    • do not use more than directed
    • drink a full glass of water with each dose
    • adults and children 12 years and over: take 4 to 8  tablets every 4 hours; not more than 48 tablets in 24 hours or as directed by a doctor
    • children under 12 years: ask a doctor
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  • Other information

    • each tablet contains: calcium 18 mg, and magnesium 15 mg
    • store at controlled room temperature 200 -  250 C (680 -  770 F)
    • protect from freezing
    • read all product information before using. Keep this box for important information.

    ADDITIONAL INFORMATION LISTED ON OTHER PANELS

    Product description -- Round, white film-coated tablets debossed with “ b “ on one side

    TAMPER-EVIDENT BOTTLE

    DO NOT USE IF INNER FOIL SEAL IMPRINTED WITH “SEALED for YOUR PROTECTION”

    IS BROKEN OR MISSING

    THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

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  • Inactive ingredients

    benzoic acid, carnauba wax, corn starch, FD&C blue #1, hypromellose, light mineral oil, magnesium stearate, microcrystalline cellulose, polysorbate 20, polysorbate 80, povidone, pregelatinized starch, propylene glycol, simethicone emulsion, sorbitan monolaurate, talc, titanium dioxide

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  • Questions or comments?

    1-800-468-7746

    Dist. by: Novartis Consumer Health, Inc.

    Parsippany, NJ 07054-0622 ©20##

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  • Principal Display
  • INGREDIENTS AND APPEARANCE
    BUFFERIN  LOW DOSE BUFFERED ASPIRIN
    aspirin tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0067-6424
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ASPIRIN (ASPIRIN) ASPIRIN 81 mg
    Inactive Ingredients
    Ingredient Name Strength
    BENZOIC ACID  
    CALCIUM CARBONATE  
    CARNAUBA WAX  
    CELLULOSE, MICROCRYSTALLINE  
    DIMETHICONE 410  
    FD&C BLUE NO. 1  
    LIGHT MINERAL OIL  
    MAGNESIUM CARBONATE  
    MAGNESIUM OXIDE  
    MAGNESIUM STEARATE  
    POLYSORBATE 20  
    POLYSORBATE 80  
    POVIDONE  
    PROPYLENE GLYCOL  
    SORBITAN MONOLAURATE  
    STARCH, CORN  
    TALC  
    TITANIUM DIOXIDE  
    Product Characteristics
    Color WHITE (WHITE) Score no score
    Shape ROUND Size 8mm
    Flavor Imprint Code b
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0067-6424-13 1 in 1 CARTON
    1 130 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part343 03/11/2011
    Labeler - Novartis Consumer Health, Inc. (879821635)
    Establishment
    Name Address ID/FEI Business Operations
    Novartis Consumer health 129836151 ANALYSIS, MANUFACTURE
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