FDA.reportPublic FDA data

Bufferin Arthritis

Manufacturer
Dr. Reddy's Laboratories Inc.
Effective date
2019-12-09
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:01:56

Label at a glance#

ProductBufferin Arthritis
Active ingredientAspirin
Label structure11 sections

Indications and 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

Dosage and administration

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

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 PRODUCT DATA ELEMENTS SECTION

SPL UNCLASSIFIED SECTION

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 magnesium carbonate, calcium 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
    • minor pain of arthritis
    • backache
    • toothache
    • the common cold
    • muscular aches
    • premenstrual & menstrual cramps
  • temporarily reduces fever

Warnings

WARNINGS SECTION

Reye's syndrome

SPL UNCLASSIFIED SECTION

OTC - DO NOT USE SECTION

Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product.

OTC - WHEN USING SECTION

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
  • facial swelling
  • shock
  • 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:

  • 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
  • take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR SECTION

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

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking a prescription drug for

  • gout
  • diabetes
  • arthritis

OTC - STOP USE SECTION

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.

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 (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

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

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

Questions or comments?

OTC - QUESTIONS SECTION

1-800-790-6417

PRINCIPAL DISPLAY PANEL - 60 Tablet Bottle Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bufferin arthritis-2Bufferin arthritis-2

Tough on pain. Gentler to your stomach.

BUFFERIN® Arthritis

BUFFERED ASPIRIN (NSAID)

Pain Reliever/Fever Reducer

60 COATED TABLETS
325 mg EACH

THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

Bufferin arthritis-1
Bufferin arthritis-1

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
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657Product name120150929
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
55741-000-602021-01-29C16284748780-1ba0f9c33-5dba-a910-e053-dadaa90a0b85Bufferin Arthritis

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55741-000-60Bufferin Arthritis60 in 1 BOTTLETABLET602
55741-000-60Bufferin Arthritis1 in 1 BOXTABLET12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55741-000BUFFERIN ARTHRITIS (ASPIRIN) TABLET [DR. REDDY'S LABORATORIES INC.]2Legacy NDC, 2 package rows20191211_bf2d3001-a772-ddb1-e17c-3a47b4cbace2.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55741-00055741-000-60

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
AspirinR16CO5Y76EACTIB
citric acid monohydrate2968PHW8QPIACT
starch, cornO8232NY3SJIACT
Sodium Phosphate, DibasicGR686LBA74IACT
hypromelloses3NXW29V3WOIACT
cellulose, microcrystallineOP1R32D61UIACT
Polyethylene Glycol, Unspecified3WJQ0SDW1AIACT
propylene glycol6DC9Q167V3IACT
sodium lauryl sulfate368GB5141JIACT
talc7SEV7J4R1UIACT
titanium dioxide15FIX9V2JPIACT

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
9853c3cb-7d1b-d407-446d-363e2c771b4cbf2d3001-a772-ddb1-e17c-3a47b4cbace22019-12-09WarningsExact identifier
spl id: 9853c3cb-7d1b-d407-446d-363e2c771b4c
spl set id: bf2d3001-a772-ddb1-e17c-3a47b4cbace2

Reported adverse events (FAERS/openFDA)#

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