Indications and uses
relieves • travelers’ diarrhea • diarrhea • upset stomach due to overindulgence in food and drink, including: • heartburn • indigestion • nausea • gas • belching • fullness
Stomach Relief
- Manufacturer
- Spirit Pharmaceuticals LLC
- Effective date
- 2024-12-10
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- full-release
- Hydrated at
- 2026-06-01 00:42:00
Label at a glance#
ProductStomach Relief
Active ingredientBISMUTH SUBSALICYLATE
Label structure15 sections
Dosage and administration
• swallow with water, do not chew • adults and children 12 years and over: • 2 softgels (1 dose) every 1/2 hour or 4 softgels (2 doses) every hour as needed for diarrhea • 2 soft gels (1 dose) every 1/2 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...
Storage and handling
• each softgel contains: Salicylate 99 mg • very low sodium • store between 15–30°C (59–86°F)
Contacts and useful links#
Label contents#
Full prescribing information#
Active Ingredient (in each tablet)
Bismuth subsalicylate 262 mg
Purpose
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 if you are
you are taking any drug for • anticoagulation (thinning the blood) • diabetes • gout • arthritis
When using this product
• symptoms get worse or last more than 2 days • ringing in the ears or loss of hearing occurs • diarrhea lasts more than 2 days
If pregnant or breast-feeding,
ask a health professional before use.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
Directions
• swallow with water, do not chew • adults and children 12 years and over: • 2 softgels (1 dose) every 1/2 hour or 4 softgels (2 doses) every hour as needed for diarrhea • 2 soft gels (1 dose) every 1/2 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 99 mg • very low sodium • store between 15–30°C (59–86°F)
Inactive ingredients
Aerosil, beeswax, FD&C Red No. 33, FD&C Yellow No. 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
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 |
|---|---|---|---|---|---|---|
| 68210-4238-5 | Stomach Relief | 60 in 1 POUCH | CAPSULE, LIQUID FILLED | 60 | 4 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68210-4238 | STOMACH RELIEF (BISMUTH SUBSALICYLATE) CAPSULE, LIQUID FILLED [SPIRIT PHARMACEUTICALS LLC] | 4 | Legacy NDC, 1 package rows | 20241212_73d0ad99-9fe9-4258-9e3b-421ef173ae2f.zip |
Products#
Every source-derived product name is available through these pages.
- Stomach Relief
- Bismuth subsalicylate
- SYNTHETIC BEESWAX
- SILICON
- D&C RED NO. 33
- FD&C YELLOW NO. 6
- GELATIN
- GLYCERIN
- PARAFFIN
- WATER
- LECITHIN, SOYBEAN
- HYDROXYMETHYL CELLULOSE
- SORBITOL SOLUTION
- TITANIUM DIOXIDE
- SALICYLIC ACID
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 68210-4238 | 68210-4238-5 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SYNTHETIC BEESWAX | 08MNR5YE2R | IACT |
| SILICON | Z4152N8IUI | IACT |
| D&C RED NO. 33 | 9DBA0SBB0L | IACT |
| FD&C YELLOW NO. 6 | H77VEI93A8 | IACT |
| GELATIN | 2G86QN327L | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| PARAFFIN | I9O0E3H2ZE | IACT |
| WATER | 059QF0KO0R | IACT |
| LECITHIN, SOYBEAN | 1DI56QDM62 | IACT |
| HYDROXYMETHYL CELLULOSE | 273FM27VK1 | IACT |
| SORBITOL SOLUTION | 8KW3E207O2 | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | 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 |
|---|---|---|---|---|---|---|
| 28f2733e-963a-f0e0-e063-6394a90a0a9d | 73d0ad99-9fe9-4258-9e3b-421ef173ae2f | 2024-12-10 | Warnings | 28f2733e-963a-f0e0-e063-6394a90a0a9d 73d0ad99-9fe9-4258-9e3b-421ef173ae2f |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.