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
- Freds Inc
- Effective date
- 2023-11-28
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 5
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 21:19:55
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 dehydrati...
Storage and handling
each 30 mL contains : sodium 6 mg each 30 mL contains : salicylate 243 mg low sodium keep tightly closed protect from freezing avoid excessive heat (over 104ºF or 40ºC)
Contacts and useful links#
Websitewww.fredsinc.com
www.fredsinc.com
www.fredsinc.comLabel 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 ahould 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 6 mg
- each 30 mL contains: salicylate 243 mg
- low sodium
- 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
Questions or comments?
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Principal Display Panel
Compare to the Active Ingredient in Pepto-Bismol®*
Stomach Relief
Bismuth subsalicylate 525 mg
Upset Stomach Reliever / Antidiarrheal
REGULAR STRENGTH
Relieves Upset Stomach, Heartburn, Indigestion, Nausea, Diarrhea
Alcohol Free
Sugar Free
FL OZ (mL)
*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 UNDER AROUND DOSAGE CUP OR UNDER CAP IS BROKEN OR MISSING.
DISTRIBUTED BY: fred's Inc.
4300 NEW GETWELL RD, MEMPHIS, TN 38118
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 | |
| 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)
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 55315-372 | 55315-372-08 |
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 |
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 |
|---|---|---|---|---|---|---|
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | FILM / BUCCAL | 3 mg | ||
| D&C RED NO. 22 | D&C RED NO. 22 | 1678RKX8RT | TABLET, COATED / ORAL | NA | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | TABLET / RECTAL | 0.6 mg | ||
| SORBIC ACID | SORBIC ACID | X045WJ989B | TABLET, COATED / ORAL | 1 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | PASTE / ORAL | 3 mg | ||
| SORBIC ACID | SORBIC ACID | X045WJ989B | CONCENTRATE / ORAL | 1 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | TABLET / SUBLINGUAL | 7 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | PASTE, DENTIFRICE / DENTAL | 0.2 %w/w | ||
| MAGNESIUM ALUMINUM SILICATE | MAGNESIUM ALUMINUM SILICATE | 6M3P64V0NC | LIQUID / ORAL | 82 mg/5ml | ||
| BENZOIC ACID | BENZOIC ACID | 8SKN0B0MIM | AEROSOL, FOAM / TOPICAL | 1 mg | ||
| MAGNESIUM ALUMINUM SILICATE | MAGNESIUM ALUMINUM SILICATE | 6M3P64V0NC | GRANULE, FOR SUSPENSION / ORAL | 12.5 mg/5ml | ||
| SORBIC ACID | SORBIC ACID | X045WJ989B | SUSPENSION / ORAL | 40 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | TABLET, FOR SUSPENSION / ORAL | 6 mg | ||
| MAGNESIUM ALUMINUM SILICATE | MAGNESIUM ALUMINUM SILICATE | 6M3P64V0NC | LOTION / TOPICAL | 1.5 %w/w | ||
| BENZOIC ACID | BENZOIC ACID | 8SKN0B0MIM | SOLUTION / ORAL | 100 mg | ||
| BENZOIC ACID | BENZOIC ACID | 8SKN0B0MIM | LIQUID / ORAL | 2 mg/1ml | ||
| BENZOIC ACID | BENZOIC ACID | 8SKN0B0MIM | INJECTION / INTRAMUSCULAR | 5 %w/v | ||
| D&C RED NO. 28 | D&C RED NO. 28 | 767IP0Y5NH | POWDER, FOR SOLUTION / ORAL | 3 mg | ||
| MAGNESIUM ALUMINUM SILICATE | MAGNESIUM ALUMINUM SILICATE | 6M3P64V0NC | PASTE, DENTIFRICE / DENTAL | 0.4 %w/w | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | SOLUTION / RESPIRATORY (INHALATION) | NA | ||
| SORBIC ACID | SORBIC ACID | X045WJ989B | CREAM / TOPICAL | 14 mg | ||
| SORBIC ACID | SORBIC ACID | X045WJ989B | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 1 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | TABLET / ORAL | 43 mg | ||
| D&C RED NO. 22 | D&C RED NO. 22 | 1678RKX8RT | SUSPENSION / ORAL | NA | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | TABLET, ORALLY DISINTEGRATING / ORAL | 10 mg | ||
| SORBIC ACID | SORBIC ACID | X045WJ989B | LOTION / TOPICAL | 4 mg | ||
| BENZOIC ACID | BENZOIC ACID | 8SKN0B0MIM | SUPPOSITORY / VAGINAL | 2 mg | ||
| D&C RED NO. 28 | D&C RED NO. 28 | 767IP0Y5NH | CAPSULE / ORAL | 1 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | SOLUTION / RECTAL | 665 mg | ||
| BENZOIC ACID | BENZOIC ACID | 8SKN0B0MIM | ELIXIR / ORAL | 90 mg | ||
| BENZOIC ACID | BENZOIC ACID | 8SKN0B0MIM | TABLET, FILM COATED / ORAL | NA | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | SOLUTION / DENTAL | 0.05 %w/v | ||
| MAGNESIUM ALUMINUM SILICATE | MAGNESIUM ALUMINUM SILICATE | 6M3P64V0NC | TABLET, CHEWABLE / ORAL | 12 mg | ||
| MAGNESIUM ALUMINUM SILICATE | MAGNESIUM ALUMINUM SILICATE | 6M3P64V0NC | POWDER, FOR SUSPENSION / ORAL | NA | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | SUSPENSION / RECTAL | 290 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | OINTMENT / TOPICAL | NA | ||
| MAGNESIUM ALUMINUM SILICATE | MAGNESIUM ALUMINUM SILICATE | 6M3P64V0NC | CONCENTRATE / ORAL | 410 mg/5ml | ||
| D&C RED NO. 28 | D&C RED NO. 28 | 767IP0Y5NH | TABLET / ORAL | NA | ||
| BENZOIC ACID | BENZOIC ACID | 8SKN0B0MIM | LOTION / TOPICAL | 0.2 %w/w | ||
| BENZOIC ACID | BENZOIC ACID | 8SKN0B0MIM | MOUTHWASH / BUCCAL | NA | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | INJECTION / INTRAMUSCULAR | 22 mg | ||
| BENZOIC ACID | BENZOIC ACID | 8SKN0B0MIM | GEL / TOPICAL | 0.1 %w/w | ||
| BENZOIC ACID | BENZOIC ACID | 8SKN0B0MIM | SYRUP / ORAL | 20 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | SOLUTION / ORAL | 665 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | PASTE / DENTAL | 0.3 %w/w | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | SUSPENSION / ORAL | 5000 mg/5ml | ||
| D&C RED NO. 28 | D&C RED NO. 28 | 767IP0Y5NH | POWDER, FOR SUSPENSION / ORAL | 0.7 mg/5ml | ||
| SORBIC ACID | SORBIC ACID | X045WJ989B | SYRUP / ORAL | 80 mg | ||
| MAGNESIUM ALUMINUM SILICATE | MAGNESIUM ALUMINUM SILICATE | 6M3P64V0NC | TABLET / ORAL | 60 mg | ||
| D&C RED NO. 22 | D&C RED NO. 22 | 1678RKX8RT | CAPSULE, EXTENDED RELEASE / ORAL | NA | ||
| D&C RED NO. 28 | D&C RED NO. 28 | 767IP0Y5NH | CAPSULE, EXTENDED RELEASE / ORAL | 0.2 mg | ||
| D&C RED NO. 28 | D&C RED NO. 28 | 767IP0Y5NH | CAPSULE, DELAYED RELEASE / ORAL | 1 mg | ||
| BENZOIC ACID | BENZOIC ACID | 8SKN0B0MIM | CREAM / VAGINAL | 10 mg | ||
| D&C RED NO. 28 | D&C RED NO. 28 | 767IP0Y5NH | SUSPENSION / ORAL | 2.5 mg/5ml | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | POWDER, FOR SUSPENSION / ORAL | 85 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | CONCENTRATE / ORAL | 6 mg | ||
| SORBIC ACID | SORBIC ACID | X045WJ989B | TABLET, DELAYED RELEASE / ORAL | 0.03 mg | ||
| BENZOIC ACID | BENZOIC ACID | 8SKN0B0MIM | CONCENTRATE / ORAL | 12.5 mg/5ml | ||
| SORBIC ACID | SORBIC ACID | X045WJ989B | EMULSION / OPHTHALMIC | 1 mg | ||
| MAGNESIUM ALUMINUM SILICATE | MAGNESIUM ALUMINUM SILICATE | 6M3P64V0NC | TABLET, EXTENDED RELEASE / ORAL | 70 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 |
|---|---|---|---|---|---|---|
| c8b52001-3569-4453-97bd-a66ee8b67ef0 | a5e48b65-07bd-4fa7-be40-5f1ead3f9929 | 2023-11-28 | Warnings | c8b52001-3569-4453-97bd-a66ee8b67ef0 a5e48b65-07bd-4fa7-be40-5f1ead3f9929 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.