Your browser does not support JavaScript! BUFFERIN LOW DOSE BUFFERED ASPIRIN (ASPIRIN) TABLET [NOVARTIS CONSUMER HEALTH, INC.]
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BUFFERIN LOW DOSE BUFFERED ASPIRIN (aspirin) tablet
[Novartis Consumer Health, Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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 Sections

TAMPER-EVIDENT BOTTLE

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

IS BROKEN OR MISSING

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

Purpose

Pain reliever

Uses

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

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

Do Not Use

  • if you have ever had an allergic reaction to aspirin or any other pain reliever/fever reducer

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

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

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

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

Overdose

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

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

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

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

Questions or comments?

1-800-468-7746

Dist. by: Novartis Consumer Health, Inc.

Parsippany, NJ 07054-0622 ©20##

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BUFFERIN  LOW DOSE BUFFERED ASPIRIN
aspirin tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0067-6424
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (ASPIRIN) ASPIRIN81 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorWHITE (WHITE) Scoreno score
ShapeROUNDSize8mm
FlavorImprint Code b
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0067-6424-131 in 1 CARTON
1130 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34303/11/2011
Labeler - Novartis Consumer Health, Inc. (879821635)
Establishment
NameAddressID/FEIBusiness Operations
Novartis Consumer health129836151ANALYSIS, MANUFACTURE

Revised: 3/2011
 
Novartis Consumer Health, Inc.

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