FDA.reportPublic FDA data

Bufferin Regular Strength Pain Relief

Manufacturer
Genomma Lab USA
Effective date
2025-02-25
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:56:03

Label at a glance#

ProductBufferin Regular Strength Pain Relief
Active ingredientaspirin
Label structure11 sections

Indications and uses

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

Dosage and administration

drink a full glass of water with each dose adults and children 12 years and over: take 2 tablets every 4 hours not to exceed 12 tablets in 24 hours unless directed by a doctor children under 12 years: do not use unless directed by a doctor

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

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

1 nonsteroidal anti-inflammatory drug

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Reye's syndrome

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

Aspirin may cause a severe allergic reaction, which may include:

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

Stomach bleeding warning

SPL UNCLASSIFIED SECTION

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

OTC - DO NOT USE SECTION

  • 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

OTC - ASK DOCTOR SECTION

  • 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

OTC - ASK DOCTOR/PHARMACIST SECTION

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

OTC - STOP USE SECTION

  • 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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • drink a full glass of water with each dose
  • adults and children 12 years and over: take 2 tablets every 4 hours not to exceed 12 tablets in 24 hours unless directed by a doctor
  • children under 12 years: do not use unless directed by a doctor

Other information

STORAGE AND HANDLING SECTION

  • 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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

1-877-994-3666

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 325 mg Table Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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
PRINCIPAL DISPLAY PANEL - 325 mg Table Bottle Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
212033aspirin 325 MG Oral TabletPSN2
260847Bufferin 325 MG Oral TabletPSN2
260847aspirin 325 MG Oral Tablet [Bufferin]SBD2
212033aspirin 325 MG Oral TabletSCD2
212033ASA 325 MG Oral TabletSY2
260847ASA 325 MG Oral Tablet [Bufferin]SY2
260847Bufferin 325 MG Oral TabletSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ASPIRIN Pharmacologic Class Indexing3Indexing - Pharmacologic Class20191108

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657Product name120150929
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
9007e8a7-ff50-f9b9-7945-f2a1deadd94eProduct name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50066-610-132025-02-25C16284748780-12cef2736-94c2-d83d-e063-dadaa90ab31fBufferin ® Regular Strength Pain Relief
50066-610-302025-02-25C16284748780-12cef2736-94c2-d83d-e063-dadaa90ab31fBufferin ® Regular Strength Pain Relief
50066-610-132025-01-30C16284748780-12cef2736-94c2-d83d-e063-dadaa90ab31fBufferin ® Regular Strength Pain Relief
50066-610-302025-01-30C16284748780-12cef2736-94c2-d83d-e063-dadaa90ab31fBufferin ® Regular Strength Pain Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50066-610-13Bufferin Regular Strength Pain Relief130 in 1 BOTTLE, PLASTICTABLET, COATED1302
50066-610-13Bufferin Regular Strength Pain Relief1 in 1 CARTONTABLET, COATED12
50066-610-30Bufferin Regular Strength Pain Relief30 in 1 BOTTLE, PLASTICTABLET, COATED302
50066-610-30Bufferin Regular Strength Pain Relief1 in 1 CARTONTABLET, COATED12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50066-610BUFFERIN REGULAR STRENGTH PAIN RELIEF (ASPIRIN) TABLET, COATED [GENOMMA LAB USA]2Current NDC, Legacy NDC, 4 package rows20250227_3543b2bf-1062-468a-a5dc-eabb2408af8c.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50066-61050066-610-13, 50066-610-30

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
aspirinR16CO5Y76EACTIB
calcium carbonateH0G9379FGKIACT
magnesium carbonate0E53J927NAIACT
magnesium oxide3A3U0GI71GIACT
anhydrous citric acidXF417D3PSLIACT
Propylene glycol6DC9Q167V3IACT
microcrystalline celluloseOP1R32D61UIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bufferin Regular Strength Pain ReliefASPIRINGenomma Lab USA3543b2bf-1062-468a-a5dc-eabb2408af8c2025-02-25WarningsExact identifier
ndc (package): 50066-610-13
ndc (package): 50066-610-30
ndc (product): 50066-610
ndc11 (package): 50066061013
ndc11 (package): 50066061030
spl id: 4f652a68-82a2-4c22-acc4-2cb28f96b358
spl set id: 3543b2bf-1062-468a-a5dc-eabb2408af8c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.