Label: BUFFERIN- aspirin tablet

  • NDC Code(s): 55741-013-13
  • Packager: Dr. Reddy's Laboratories Inc.
  • 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 June 15, 2016

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient (in each tablet)

    Buffered aspirin equal to 325 mg aspirin (NSAID)1 (buffered with magnesium carbonate, calcium carbonate and magnesium oxide)


    1
    nonsteroidal anti-inflammatory drug
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  • Purpose

    Pain reliever/fever reducer

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  • Uses

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

    Do not use if you are allergic to aspirin or any other pain reliever/fever reducer.

    Ask a doctor before use if

    • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
    • stomach bleeding warning applies to you
    • you have a history of stomach problems, such as heartburn
    • you have asthma
    • 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
    • symptoms do not improve
    • 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
    • new symptoms occur
    • 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

    • adults and children 12 years and over: 2 tablets with a full glass of water. Dosage may be repeated every 4 hours while symptoms persist. Do not exceed 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

    • each tablet contains: calcium 35 mg and magnesium 40 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
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  • Inactive ingredients

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

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  • Questions or comments?

    1-800-790-6417

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  • PRINCIPAL DISPLAY PANEL - 130 Tablet Bottle Box

    NDC 55741-013-13

    Tough on pain. Gentler to your stomach.
    than plain aspirin*

    BUFFERIN®

    BUFFERED ASPIRIN (NSAID)

    Pain Reliever/Fever Reducer

    130 COATED TABLETS
    325 mg EACH

    THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

    PRINCIPAL DISPLAY PANEL - 130 Tablet Bottle Box
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  • INGREDIENTS AND APPEARANCE
    BUFFERIN 
    aspirin tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:55741-013
    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
    citric acid monohydrate (UNII: 2968PHW8QP)  
    starch, corn (UNII: O8232NY3SJ)  
    Sodium Phosphate, Dibasic (UNII: GR686LBA74)  
    hypromelloses (UNII: 3NXW29V3WO)  
    cellulose, microcrystalline (UNII: OP1R32D61U)  
    polyethylene glycols (UNII: 3WJQ0SDW1A)  
    propylene glycol (UNII: 6DC9Q167V3)  
    sodium lauryl sulfate (UNII: 368GB5141J)  
    talc (UNII: 7SEV7J4R1U)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    Product Characteristics
    Color WHITE Score no score
    Shape ROUND Size 11mm
    Flavor Imprint Code B
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55741-013-13 1 in 1 BOX 05/24/2016
    1 130 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part343 05/24/2016
    Labeler - Dr. Reddy's Laboratories Inc. (802315887)
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