BUFFERIN LOW DOSE BUFFERED ASPIRIN- aspirin tablet 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

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.

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Drug Facts

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##

Principal Display

Carton Image
BUFFERIN  LOW DOSE BUFFERED ASPIRIN
aspirin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0067-6424
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN81 mg
Inactive Ingredients
Ingredient NameStrength
BENZOIC ACID (UNII: 8SKN0B0MIM)  
CALCIUM CARBONATE (UNII: H0G9379FGK)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
DIMETHICONE 410 (UNII: TYU5GP6XGE)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
MAGNESIUM CARBONATE (UNII: 0E53J927NA)  
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SORBITAN MONOLAURATE (UNII: 6W9PS8B71J)  
STARCH, CORN (UNII: O8232NY3SJ)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
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 CARTON03/11/201102/12/2013
1130 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34303/11/201102/12/2013
Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)

Revised: 7/2019
 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC