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#
Contacts and useful links#
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
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| BISMUTH CATION Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 0be8e4ae-4d57-49f3-b3a9-e4728b4e8d15 | Product name | 1 | 20240313 |
| dea2eded-d1e7-46bb-9a3d-f8dc20de6277 | Product name | 1 | 20190408 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 76162-406-24 | TopCare Bismuth Stomach Relief | 24 in 1 BOTTLE | TABLET, CHEWABLE | 24 | 1 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- TopCare Bismuth Stomach Relief
- Bismuth
- BISMUTH SUBSALICYLATE
- BISMUTH CATION
- SUCROSE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 76162-406 | 76162-406-24 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| BISMUTH SUBSALICYLATE | 62TEY51RR1 | ACTIB |
| SUCROSE | C151H8M554 | IACT |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| TopCare Bismuth Stomach Relief | BISMUTH | TopCo | 308f4b2a-22ff-42b9-e063-6394a90acc75 | 2025-03-17 | Warnings | 76162-406-24 76162-406 76162040624 308f4b2a-2300-42b9-e063-6394a90acc75 308f4b2a-22ff-42b9-e063-6394a90acc75 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
