Indications and uses
relieves travelers' diarrhea diarrhea upset stomach due to overindulgence in food and drink, including: heartburn indigestion nausea gas fullness belching
Stomach Relief
- Manufacturer
- TOP CARE (Topco Associates LLC)
- Effective date
- 2023-10-13
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 5
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 21:24:15
Label at a glance#
ProductStomach Relief Regular Strength
Active ingredientBISMUTH SUBSALICYLATE
Label structure10 sections
Dosage and administration
shake well before using mL = milliliter measure only with dosing cup provided. Do not use any other dosing device. keep dosing cup with product adults and children 12 years and over 30 mL (1 dose) every 1/2 to 1 hour as needed do not exceed 8 doses (240 mL) 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 dehydra...
Storage and handling
each 30 mL contains: sodium 14 mg each 30 mL contains: salicylate 248 mg sugar free keep tightly closed protect from freezing avoid excessive heat (over 104ºF or 40ºC)
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredient (in each 30 mL)
Bismuth subsalicylate 525 mg
Purpose
Upset stomach reliever/Antidiarrheal
Uses
relieves
- travelers' diarrhea
- diarrhea
- upset stomach due to overindulgence in food and drink, including:
- heartburn
- indigestion
- nausea
- gas
- fullness
- belching
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
- diabetes
- gout
- arthritis
- anticoagulation (thinning the blood)
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
If pregnant or breast-feeding,
ask a health professional before use.
Keep out of reach of childen.
In case of overdose, get medical help or contact a Posion Control Center right away. (1-800-222-1222)
Directions
- shake well before using
- mL = milliliter
- measure only with dosing cup provided. Do not use any other dosing device.
- keep dosing cup with product
- adults and children 12 years and over
- 30 mL (1 dose) every 1/2 to 1 hour as needed
- do not exceed 8 doses (240 mL) 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
- each 30 mL contains: sodium 14 mg
- each 30 mL contains: salicylate 248 mg
- sugar free
- keep tightly closed
- protect from freezing
- avoid excessive heat (over 104ºF or 40ºC)
Inactive ingredients
benzoic acid, D&C red #22, D&C red #28, flavor, magnesium aluminum silicate, methylcellulose, purified water, saccharin sodium, salicylic acid, sodium salicylate, sorbic acid, sucralose
Questions or comments?
Call toll free 1-888-423-0139
Principal Display Panel
COMPARE TO PEPTO-BISMOL® ACTIVE INGREDIENT*
REGULAR STRENGTH
Stomach Relief
BISMUTH SUBSALICYLATE 525 mg
UPSET STOMACH RELIEVER/ANTIDIARRHEAL
5 SYMPTOM DIGESTIVE RELIEF
- Heartburn
- Indigestion
- nausea
- Upset Stomach
- diarrhea
FL OZ (mL)
CHERRY FLAVOR
*This product is not manufactured or distributed by The Procter & Gamble Company, Pepto-Bismol® is a registered trademark of The Procter & Gamble Company.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND DOSAGE CUP OR UNDER CAP IS BROKEN OR MISSING.
DISTRIBUTED BY:TOPCO ASSOCIATES LLC
ELK GROVE VILLAGE, IL 60007
Package Label
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| BISMUTH SUBSALICYLATE | ACTIVE INGREDIENT | 62TEY51RR1 | 1 | |
| SALICYLIC ACID | ACTIVE MOIETY | O414PZ4LPZ | 1 | |
| BENZOIC ACID | INACTIVE INGREDIENT | 8SKN0B0MIM | 1 | |
| D&C RED NO. 22 | INACTIVE INGREDIENT | 1678RKX8RT | 1 | |
| D&C RED NO. 28 | INACTIVE INGREDIENT | 767IP0Y5NH | 1 | |
| MAGNESIUM ALUMINUM SILICATE | INACTIVE INGREDIENT | 6M3P64V0NC | 1 | |
| METHYLCELLULOSE (1500 MPA.S) | INACTIVE INGREDIENT | P0NTE48364 | 1 | |
| SACCHARIN SODIUM | INACTIVE INGREDIENT | SB8ZUX40TY | 1 | |
| SALICYLIC ACID | INACTIVE INGREDIENT | O414PZ4LPZ | 1 | |
| SODIUM SALICYLATE | INACTIVE INGREDIENT | WIQ1H85SYP | 1 | |
| SORBIC ACID | INACTIVE INGREDIENT | X045WJ989B | 1 | |
| SUCRALOSE | INACTIVE INGREDIENT | 96K6UQ3ZD4 | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Products#
Every source-derived product name is available through these pages.
- Stomach Relief Regular Strength
- Bismuth subsalicylate
- BISMUTH CATION
- SALICYLIC ACID
- BENZOIC ACID
- D&C RED NO. 22
- D&C RED NO. 28
- MAGNESIUM ALUMINUM SILICATE
- WATER
- SACCHARIN SODIUM
- SODIUM SALICYLATE
- SORBIC ACID
- METHYLCELLULOSE (1500 CPS)
- SUCRALOSE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 36800-045 | 36800-045-16, 36800-045-08 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| BISMUTH SUBSALICYLATE | 62TEY51RR1 | ACTIB |
| BENZOIC ACID | 8SKN0B0MIM | IACT |
| D&C RED NO. 22 | 1678RKX8RT | IACT |
| D&C RED NO. 28 | 767IP0Y5NH | IACT |
| MAGNESIUM ALUMINUM SILICATE | 6M3P64V0NC | IACT |
| WATER | 059QF0KO0R | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| SALICYLIC ACID | O414PZ4LPZ | IACT |
| SODIUM SALICYLATE | WIQ1H85SYP | IACT |
| SORBIC ACID | X045WJ989B | IACT |
| METHYLCELLULOSE (1500 CPS) | P0NTE48364 | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| BENZOIC ACID | BENZOIC ACID | 8SKN0B0MIM | INJECTION, SOLUTION / INTRAMUSCULAR | 0.2 %w/v | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | GUM, CHEWING / BUCCAL | 70 mg | ||
| MAGNESIUM ALUMINUM SILICATE | MAGNESIUM ALUMINUM SILICATE | 6M3P64V0NC | LOTION / TOPICAL | 1.5 %w/w | ||
| SORBIC ACID | SORBIC ACID | X045WJ989B | TABLET, FILM COATED / ORAL | 5 mg | ||
| D&C RED NO. 28 | D&C RED NO. 28 | 767IP0Y5NH | POWDER, FOR SOLUTION / ORAL | 3 mg | ||
| BENZOIC ACID | BENZOIC ACID | 8SKN0B0MIM | GEL / RECTAL | 11 mg | ||
| D&C RED NO. 28 | D&C RED NO. 28 | 767IP0Y5NH | CAPSULE, COATED PELLETS / ORAL | NA | ||
| D&C RED NO. 28 | D&C RED NO. 28 | 767IP0Y5NH | TABLET / ORAL | NA | ||
| D&C RED NO. 28 | D&C RED NO. 28 | 767IP0Y5NH | CAPSULE, EXTENDED RELEASE / ORAL | 0.2 mg | ||
| SORBIC ACID | SORBIC ACID | X045WJ989B | TABLET, COATED / ORAL | 1 mg | ||
| BENZOIC ACID | BENZOIC ACID | 8SKN0B0MIM | GEL / TOPICAL | 0.1 %w/w | ||
| SORBIC ACID | SORBIC ACID | X045WJ989B | TABLET / SUBLINGUAL | 0.16 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | WAFER / ORAL | 8 mg | ||
| MAGNESIUM ALUMINUM SILICATE | MAGNESIUM ALUMINUM SILICATE | 6M3P64V0NC | SUSPENSION / RECTAL | 14480 mg | ||
| SORBIC ACID | SORBIC ACID | X045WJ989B | TABLET, CHEWABLE / ORAL | NA | ||
| SORBIC ACID | SORBIC ACID | X045WJ989B | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 1 mg | ||
| MAGNESIUM ALUMINUM SILICATE | MAGNESIUM ALUMINUM SILICATE | 6M3P64V0NC | SHAMPOO / TOPICAL | 1.25 %w/w | ||
| D&C RED NO. 22 | D&C RED NO. 22 | 1678RKX8RT | TABLET, COATED / ORAL | NA | ||
| BENZOIC ACID | BENZOIC ACID | 8SKN0B0MIM | MOUTHWASH / BUCCAL | NA | ||
| SORBIC ACID | SORBIC ACID | X045WJ989B | SOLUTION / ORAL | 80 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | SPRAY, METERED / NASAL | 2 mg | ||
| SORBIC ACID | SORBIC ACID | X045WJ989B | SOLUTION / OPHTHALMIC | 0.2 %w/v | ||
| SORBIC ACID | SORBIC ACID | X045WJ989B | CREAM / TOPICAL | 14 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | INJECTION / INTRAVENOUS | 22 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | TABLET, ORALLY DISINTEGRATING / ORAL | 60 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | SUSPENSION / RECTAL | 290 mg | ||
| SORBIC ACID | SORBIC ACID | X045WJ989B | CONCENTRATE / ORAL | 1 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | TABLET / ORAL | 45 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | SYRUP / ORAL | 80 mg | ||
| MAGNESIUM ALUMINUM SILICATE | MAGNESIUM ALUMINUM SILICATE | 6M3P64V0NC | GRANULE, FOR SUSPENSION / ORAL | 12.5 mg/5ml | ||
| MAGNESIUM ALUMINUM SILICATE | MAGNESIUM ALUMINUM SILICATE | 6M3P64V0NC | CAPSULE / ORAL | 60 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | AEROSOL, METERED / RESPIRATORY (INHALATION) | 0.05 %w/w | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | SOLUTION / RECTAL | 665 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | TABLET / BUCCAL | 0.4 mg | ||
| D&C RED NO. 28 | D&C RED NO. 28 | 767IP0Y5NH | AEROSOL / TOPICAL | NA | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | SUSPENSION / ORAL | 5000 mg/5ml | ||
| MAGNESIUM ALUMINUM SILICATE | MAGNESIUM ALUMINUM SILICATE | 6M3P64V0NC | LIQUID / ORAL | 82 mg/5ml | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | SUSPENSION / ORAL | 383 mg | ||
| SORBIC ACID | SORBIC ACID | X045WJ989B | TABLET / ORAL | 10 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | CONCENTRATE / ORAL | 6 mg | ||
| D&C RED NO. 22 | D&C RED NO. 22 | 1678RKX8RT | CAPSULE / ORAL | 0.02 mg | ||
| D&C RED NO. 28 | D&C RED NO. 28 | 767IP0Y5NH | SUSPENSION / ORAL | 2.5 mg/5ml | ||
| MAGNESIUM ALUMINUM SILICATE | MAGNESIUM ALUMINUM SILICATE | 6M3P64V0NC | TABLET, EXTENDED RELEASE / ORAL | 70 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | GRANULE, FOR SOLUTION / ORAL | 5.5 mg/120ml | ||
| SORBIC ACID | SORBIC ACID | X045WJ989B | SOLUTION/ DROPS / OPHTHALMIC | 0.2 %w/v | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | TROCHE / ORAL | 60 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | FILM / BUCCAL | 3 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | TABLET, EXTENDED RELEASE / ORAL | 1 mg | ||
| SORBIC ACID | SORBIC ACID | X045WJ989B | EMULSION / OPHTHALMIC | 1 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | TABLET / SUBLINGUAL | 7 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | TABLET / ORAL | 43 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | TABLET, CHEWABLE / ORAL | 84 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | GRANULE, FOR SUSPENSION / ORAL | 23 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | POWDER, FOR SUSPENSION / ORAL | 400 mg | ||
| MAGNESIUM ALUMINUM SILICATE | MAGNESIUM ALUMINUM SILICATE | 6M3P64V0NC | PASTE, DENTIFRICE / DENTAL | 0.4 %w/w | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | GEL / DENTAL | 0.3 %w/w | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | PASTE, DENTIFRICE / DENTAL | 0.2 %w/w | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | SUSPENSION, EXTENDED RELEASE / ORAL | 16 mg | ||
| D&C RED NO. 28 | D&C RED NO. 28 | 767IP0Y5NH | SOAP / TOPICAL | NA | ||
| D&C RED NO. 28 | D&C RED NO. 28 | 767IP0Y5NH | CAPSULE, DELAYED RELEASE / ORAL | 1 mg |
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 |
|---|---|---|---|---|---|---|
| 7b77710f-2278-4357-b5ff-6adf3bc1d8a9 | 81121ea8-0625-4100-87ba-b6cd12050ce4 | 2023-10-13 | Warnings | 7b77710f-2278-4357-b5ff-6adf3bc1d8a9 81121ea8-0625-4100-87ba-b6cd12050ce4 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.