BUFFERIN REGULAR STRENGTH PAIN RELIEF- aspirin tablet, coated 
Genomma Lab USA

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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Bufferin® Regular Strength Pain Relief

Drug Facts

Active ingredient (in each tablet)

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


1
nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Uses

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
  • shock
  • facial swelling
  • asthma (wheezing)

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
  • take a blood thinning (anticoagulant) or steroid drug
  • are age 60 or older
  • have 3 or more alcoholic drinks every day while using this product
  • 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 asthma
  • you have a history of stomach problems, such as heartburn
  • 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
    • have bloody or black stools
    • vomit blood
    • 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 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 right away.

Directions

Other information

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?

1-877-994-3666

Distributed by:
Genomma Lab USA Inc.
Houston, TX 77027

PRINCIPAL DISPLAY PANEL - 325 mg Table Bottle Carton

Regular Strength

Tough on pain. Gentler to your stomach.™

BUFFERIN®
BUFFERED ASPIRIN (NSAID)

Pain Reliever
Fever Reducer

30 Coated Tablets 325 mg each

PRINCIPAL DISPLAY PANEL - 325 mg Table Bottle Carton
BUFFERIN REGULAR STRENGTH PAIN RELIEF 
aspirin tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50066-610
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
aspirin (UNII: R16CO5Y76E) (aspirin - UNII:R16CO5Y76E) aspirin325 mg
Inactive Ingredients
Ingredient NameStrength
calcium carbonate (UNII: H0G9379FGK)  
magnesium carbonate (UNII: 0E53J927NA)  
magnesium oxide (UNII: 3A3U0GI71G)  
anhydrous citric acid (UNII: XF417D3PSL)  
Propylene glycol (UNII: 6DC9Q167V3)  
microcrystalline cellulose (UNII: OP1R32D61U)  
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize9mm
FlavorImprint Code B
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50066-610-131 in 1 CARTON05/17/2021
1130 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:50066-610-301 in 1 CARTON05/17/2021
230 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34305/17/2021
Labeler - Genomma Lab USA (832323534)

Revised: 5/2021
Document Id: 93a60710-8cc3-479e-a7c0-f23a870b527c
Set id: 3543b2bf-1062-468a-a5dc-eabb2408af8c
Version: 1
Effective Time: 20210518
 
Genomma Lab USA