TopCare Bismuth Stomach Relief

Manufacturer
TopCo | SCNBestco | Betco
Effective date
2025-03-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:57:19

Label at a glance#

ProductTopCare Bismuth Stomach Relief
Active ingredientBISMUTH SUBSALICYLATE
Label structure18 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each chewable tablet)

Bismuth subsalicylate 262 mg

OTC - PURPOSE SECTION

Purpose

Upset stomachreliever and antidiarrheal

INDICATIONS & USAGE SECTION

Uses relieves

  • Traveler's diarrhea
  • Diarrhea
  • Upset stomach due to overindulgence in food or drink, ingluding
  • Heartburn
  • Indigestion
  • Nausea
  • Gas
  • Belching
  • Fullness

WARNINGS SECTION

Warnings

Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use the 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 rear but serious illness.

OTC - DO NOT USE SECTION

Allergy alert: Contains salicylate. Do not take if you are

  • Allergic to salicylates (including aspirin)
  • taking other salicylate products

OTC - DO NOT USE SECTION

Do not use if you have

An ulcer

A bleeding problem

Bloody or black stool

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • Fever
  • Mucus in the stool

OTC - ASK DOCTOR/PHARMACIST SECTION

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

  • Anticoagulation (thinning the blood)
  • Diabetes
  • Gout
  • Arthritis

OTC - WHEN USING SECTION

When using this product a temporary, but harmless, darkening of the stool and/or tongue may occur

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • Symptoms get worse or last more than 2 days
  • Ringing in the ears or loss of hearing occurs
  • Diarrhea lasts more than 2 days

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OVERDOSAGE SECTION

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

DOSAGE & ADMINISTRATION SECTION

Directions

  • Fully chew before swallowing
  • Adults and children 12 years and over:
  • 2 chewable tablets every 1/2 hour or 4 chewable tablets every hour as needed for diarrhea
  • 2 chewable tablets every 1/2 hour to 1 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea).
  • Do not exceed 8 doses (16 chewable tablets) in 24 hours.
  • Use until diarrhea stops but not more than 2 days
  • Children under 12 years: ask a doctor.
  • Drink plenty of clear fluids to help prevent dehydration caused by diarrhea.

INACTIVE INGREDIENT SECTION

Inactive ingredients: Beeswax, calcium carbonate, carmine, carnauba wax, citric acid, corn starch, corn syrup, dextrin, ethyl acetate, FD&C blue no 1 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C red no. 40 aluminum lake, FD&C yellow no. 6 aluminum lake, glycerin, gum arabic, hydrogenated coconut oil, maltodextrin, medium chain triglycerides, natural and artificial flavors, phosphoric acid, propylene glycol, shellac, sodium benzoate, sorbic acid, sorbitol, soy lecithin, soybean oil, sucrose, titanium dioxide, vegetable oil (coconut and/or canola oil), water.

OTHER SAFETY INFORMATION

Other information

  • Each chewable tablet contains: Calcium 50 mg
  • Salicylate 123 mg
  • Contains soy
  • Store between 20° to 25°C (68° to 77°F) in a dry place. Avoid excessive heat (over 40°C).

OTC - QUESTIONS SECTION

Questions? Call 1-800-245-2989 Mon - Fri, 9AM - 4PM EST

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TopCare Bismuth Stomach Relief 24ctTopCare Bismuth Stomach Relief 24ct

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308761bismuth subsalicylate 262 MG Chewable TabletPSN1
308761bismuth subsalicylate 262 MG Chewable TabletSCD1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BISMUTH CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0be8e4ae-4d57-49f3-b3a9-e4728b4e8d15Product name120240313
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76162-406-24TopCare Bismuth Stomach Relief24 in 1 BOTTLETABLET, CHEWABLE241

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76162-406TOPCARE BISMUTH STOMACH RELIEF (BISMUTH) TABLET, CHEWABLE [TOPCO]1Current NDC, 1 package rows20250321_308f4b2a-22ff-42b9-e063-6394a90acc75.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76162-40676162-406-24

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
BISMUTH SUBSALICYLATE62TEY51RR1ACTIB
SUCROSEC151H8M554IACT

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
TopCare Bismuth Stomach ReliefBISMUTHTopCo308f4b2a-22ff-42b9-e063-6394a90acc752025-03-17WarningsExact identifier
ndc (package): 76162-406-24
ndc (product): 76162-406
ndc11 (package): 76162040624
spl id: 308f4b2a-2300-42b9-e063-6394a90acc75
spl set id: 308f4b2a-22ff-42b9-e063-6394a90acc75

Reported adverse events (FAERS/openFDA)#

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