Indications and uses
relieves travelers' diarrhea diarrhea upset stomach due to overindulgence in food and drink, including: heartburn, indigestion, nausea, gas, belching fullness
Bismuth Subsalicylate
- Manufacturer
- CVS PHARMACY, INC.
- Effective date
- 2024-12-17
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 5
- Source
- full-release
- Hydrated at
- 2026-06-01 00:50:14
Label at a glance#
ProductBismuth Subsalicylate
Active ingredientBISMUTH SUBSALICYLATE
Label structure9 sections
Dosage and administration
swallow with water, do not chew adults and children 12 years and over: 2 softgels every ½ hour or 4 softgels every hour as needed for diarrhea 2 softgels every ½ hour to 1 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea) do not exceed 8 doses (16 softgels) in 24 hours use until diarrhea stops but not more than 2 days children under 12 years: ask a doctor drink plenty of cle...
Storage and handling
each softgel contains: salicylate 102.33 mg very low sodium do not exceed 25°C
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
OTC - PURPOSE SECTION
Active ingredient ( in each softgel) Purpose
Bismuth subsalicylate 262 mg ................Upset stomach reliever and anti-diarrheal
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 the blood)
- diabetes
- gout
- arthritis
When using this product
- a temporary, but harmless, darkening of the stool and/or tongue may occur
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. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- swallow with water, do not chew
- adults and children 12 years and over:
- 2 softgels every ½ hour or 4 softgels every hour as needed for
diarrhea - 2 softgels every ½ hour to 1 hour as needed for overindulgence (upset
stomach, heartburn, indigestion, nausea) - do not exceed 8 doses (16 softgels) 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
Other information
- each softgel contains: salicylate 102.33 mg
- very low sodium
- do not exceed 25°C
Inactive ingredients
aerosil, beeswax, FD&C Red#33, FD&C Yellow#6, gelatin, glycerin, light liquid paraffin, purified water, soya lecithin, sodium carboxy methyl cellulose, sorbitol solution, titanium dioxide
Questions or comments?
1-888-333-9792
PRINCIPAL DISPLAY PANEL
Stomach Relief
BISMUTH SUBSALICYLATE 262 mg
Upset stomach reliever/Antidiarrheal
Soothing relief for 5 symptoms:
• Heartburn
• Indigestion
• Upset stomach
• Nausea
• Diarrhea
12 SOFTGELS
DailyMed RxNorm Mappings#
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| dea2eded-d1e7-46bb-9a3d-f8dc20de6277 | Product name | 1 | 20190408 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69842-799-12 | Bismuth Subsalicylate | 12 in 1 BLISTER PACK | CAPSULE, GELATIN COATED | 12 | 5 | |
| 69842-799-12 | Bismuth Subsalicylate | 1 in 1 CARTON | CAPSULE, GELATIN COATED | 1 | 5 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Bismuth Subsalicylate
- SILICON DIOXIDE
- LECITHIN, SOYBEAN
- YELLOW WAX
- CARBOXYMETHYLCELLULOSE SODIUM
- LIGHT MINERAL OIL
- GELATIN
- GLYCERIN
- D&C RED NO. 33
- FD&C YELLOW NO. 6
- TITANIUM DIOXIDE
- WATER
- SALICYLIC ACID
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 69842-799 | 69842-799-12 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| LECITHIN, SOYBEAN | 1DI56QDM62 | IACT |
| YELLOW WAX | 2ZA36H0S2V | IACT |
| CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | IACT |
| LIGHT MINERAL OIL | N6K5787QVP | IACT |
| GELATIN | 2G86QN327L | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| D&C RED NO. 33 | 9DBA0SBB0L | IACT |
| FD&C YELLOW NO. 6 | H77VEI93A8 | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| WATER | 059QF0KO0R | IACT |
| BISMUTH SUBSALICYLATE | 62TEY51RR1 | ACTIB |
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 |
|---|---|---|---|---|---|---|
| 297e337b-1ce1-a590-e063-6394a90aad40 | dfb5ed78-99b5-4c8e-a36c-5e4c32fa021e | 2024-12-17 | Warnings | 297e337b-1ce1-a590-e063-6394a90aad40 dfb5ed78-99b5-4c8e-a36c-5e4c32fa021e |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.