FDA.reportPublic FDA data

Tri-Buffered Aspirin

Manufacturer
Topco Associates, LLC | LNK International, Inc.
Effective date
2019-03-28
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-02 00:28:44

Label at a glance#

ProductTri-Buffered Aspirin Regular Strength
Active ingredientASPIRIN
Label structure9 sections

Indications and uses

temporarily relieves minor aches and pains associated with: toothache the common cold backache muscular aches headache minor pain of arthritis 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#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Buffered aspirin equal to 325 mg aspirin (NSAID)*
(buffered with magnesium carbonate, calcium carbonate and magnesium oxide)
*nonsteroidal anti-inflammatory drug

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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
  • shock
  • asthma (wheezing)

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
  • take more or for a longer time than directed
  • take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
  • have had stomach ulcers or bleeding problems
  • take a blood thinning (anticoagulant) or steroid drug
  • have 3 or more alcoholic drinks every day while using this product

Do not use

OTC - DO NOT USE SECTION

if you are allergic to aspirin or any other pain reliever/fever reducer.

Ask a doctor before use if

OTC - ASK DOCTOR SECTION

  • 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 have asthma
  • you are taking a diuretic

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking a prescription drug for

  • gout
  • diabetes
  • arthritis

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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
  • new symptoms occur
  • 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
  • redness or swelling is present

These could be signs of a serious condition.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Call 1-888-423-0139

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TopCare®
health™

NDC 36800-983-30

COMPARE TO BUFFERIN® ACTIVE INGREDIENT†

REGULAR STRENGTH
Tri-Buffered
Aspirin 325 mg

PAIN RELIEVER • FEVER REDUCER (NSAID)

• OUR PHARMACISTS •
       RECOMMEND

actual
size

130 COATED TABLETS

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

†This product is not manufactured or distributed by Ducere Pharma, owner of the registered trademark Bufferin®.
50844           ORG121418330

DISTRIBUTED BY TOPCO ASSOCIATES LLC
ELK GROVE VILLAGE, IL 60007
©TOPCO   LNKA0118
QUESTIONS? 1-888-423-0139
topcare@topco.com www.topcarebrand.com

✓QUALITY GUARANTEED

Topcare 44-183
Topcare 44-183

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130036800414372GTIN-13: 0036800414372
EAN-13: 0036800414372
GTIN-12: 036800414372
UPC-A: 036800414372
GTIN storage (14 digits): 00036800414372		topcare-44-183-discontinued-1.jpg

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
36800-98336800-983-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
ASPIRINR16CO5Y76EACTIB
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
STARCH, CORNO8232NY3SJIACT
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORMGR686LBA74IACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SHELLAC46N107B71OIACT
SODIUM LAURYL SULFATE368GB5141JIACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
DIMETHICONE92RU3N3Y1OIACT
HYDROGENATED COTTONSEED OILZ82Y2C65EAIACT

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
c004b3ee-ec8b-4730-81f5-9f549b2bf4d81802f435-58c1-4e65-904e-a729e65340242019-03-28WarningsExact identifier
spl id: c004b3ee-ec8b-4730-81f5-9f549b2bf4d8
spl set id: 1802f435-58c1-4e65-904e-a729e6534024

Reported adverse events (FAERS/openFDA)#

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