Indications and uses
relieves travelers’ diarrhea diarrhea upset stomach due to overindulgence in food and drink including: heartburn indigestion nausea gas belching fullness
Topcare Stomach Relief
- Manufacturer
- TopCo Associates, LLC
- Effective date
- 2018-12-14
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 8
- Source
- full-release
- Hydrated at
- 2026-05-31 23:56:53
Label at a glance#
ProductTopcare Stomach Relief Original Strength
Active ingredientBISMUTH SUBSALICYLATE
Label structure9 sections
Dosage and administration
chew or dissolve in mouth Adults and children 12 years and over: 2 tablets every ½ to 1 hour as needed do not exceed 16 tablets in 24 hours use until diarrhea stops but not more than 2 days Children under 12 years of age: ask a doctor drink plenty of clear fluids to help prevent dehydration caused by diarrhea
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredient
Bismuth subsalicylate 262 mg (each tablet contains 102 mg salicylate)
Purpose
Antidiarrheal/Antacid
Uses
relieves
- travelers’ diarrhea
- diarrhea
- upset stomach due to overindulgence in food and drink including:
- heartburn
- indigestion
- nausea
- gas
- belching
- fullness
Warnings
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
Contains salicylate. Do not take if you are
- allergic to salicylates (including aspirin)
- taking other salicylate products
Do not use if you have
- an ulcer
- a bleeding problem
- bloody or black stool
Ask a doctor before use if you have
- fever
- mucus in the stool
Ask a doctor or pharmacist before use if
you are taking any drug for
- anticoagulation (thinning of the blood)
- diabetes
- gout
- arthritis
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
When using this product
a temporary, but harmless, darkening of the stool and/or tongue may occur
If pregnant or breast-feeding
ask a health professional before use.
Keep out of reach of children
In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Directions
- chew or dissolve in mouth
Adults and children 12 years and over: 2 tablets every ½ to 1 hour as needed
- do not exceed 16 tablets in 24 hours
- use until diarrhea stops but not more than 2 days
Children under 12 years of age: ask a doctor
- drink plenty of clear fluids to help prevent dehydration caused by diarrhea
Other information
- Phenylketonurics: contains phenylalanine 1.1mg per tablet
- Calcium content per tablet: 73mg
- save carton for full directions and warnings
- store at room temperature 15°– 30°C (59°– 86°F)
- do not use if cellophane unit is torn
Inactive ingredients
acacia gum, aspartame, calcium carbonate, D&C red #27 aluminum lake, dextrates, magnesium stearate, maltodextrin, microcrystalline cellulose, peppermint flavor, silicon dioxide
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 |
|---|---|---|---|---|---|---|
| 76162-001-85 | Topcare Stomach ReliefOriginal Strength | 6 in 1 CARTON | TABLET | 6 | 8 | |
| 76162-001-85 | Topcare Stomach ReliefOriginal Strength | 5 in 1 BLISTER PACK | TABLET | 5 | 8 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Topcare Stomach Relief Original Strength
- Bismuth subsalicylate
- BISMUTH CATION
- ACACIA
- ASPARTAME
- CALCIUM CARBONATE
- D&C RED NO. 27
- DEXTRATES
- MAGNESIUM STEARATE
- MALTODEXTRIN
- MICROCRYSTALLINE CELLULOSE
- SILICON DIOXIDE
- PEPPERMINT
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 76162-001 | 76162-001-85 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| BISMUTH SUBSALICYLATE | 62TEY51RR1 | ACTIB |
| ACACIA | 5C5403N26O | IACT |
| ASPARTAME | Z0H242BBR1 | IACT |
| CALCIUM CARBONATE | H0G9379FGK | IACT |
| D&C RED NO. 27 | 2LRS185U6K | IACT |
| DEXTRATES | G263MI44RU | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| MALTODEXTRIN | 7CVR7L4A2D | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| PEPPERMINT | V95R5KMY2B | 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 Stomach Relief Original Strength | BISMUTH SUBSALICYLATE | TopCo Associates, LLC | e4b1929c-0967-44ea-8552-6549aa2a464e | 2018-12-14 | Warnings | 76162-001-85 76162-001 76162000185 cfa0f68a-3278-47da-80b3-64e17d97fa35 e4b1929c-0967-44ea-8552-6549aa2a464e |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.