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
- Care One (American Sales Company)
- Effective date
- 2021-10-08
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 22:33:43
Label at a glance#
ProductStomach Relief Maximum Strength
Active ingredientBISMUTH SUBSALICYLATE
Label structure10 sections
Dosage and administration
mL = milliliter shake well before using 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 hour as needed do not take more than 4 doses (120 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 dehydr...
Storage and handling
each 30 mL contains: sodium 12 mg each 30 mL contains: salicylate 455 mg low sodium 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 1050 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 (1-800-222-1222) righy away.
Directions
- mL = milliliter
- shake well before using
- 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 hour as needed
- do not take more than 4 doses (120 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 12 mg
- each 30 mL contains: salicylate 455 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® Max Strength*
MAXIMUM STRENGTH
STOMACH RELIEF
Bismuth Subsalicylate 1050 mg
Upset Stomach Reliever/Antidiarrheal
Original Flavor
5 SYMPTOM DIGESTIVE RELIEF
NAUSEA, HEARTBURN, INDIGESTION, UPSET STOMACH, 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 AROUND DOSAGE CUP OR UNDER CAP IS BROKEN OR MISSING.
DISTRIBUTED BY: FOODHOLD U.S.A., LLC, LANDOVER, MD 20785
For product questions or concerns, contact us at 1-877-846-9949
Package Label
Products#
Every source-derived product name is available through these pages.
- Stomach Relief Maximum 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 |
|---|---|
| 41520-682 | 41520-682-12, 41520-682-08 |
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#
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 |
|---|---|---|---|---|---|---|
| aae30036-5465-458a-a762-b53e82293b6a | d783f187-9d9b-43cd-b527-8f11836e60bb | 2021-10-08 | Warnings | aae30036-5465-458a-a762-b53e82293b6a d783f187-9d9b-43cd-b527-8f11836e60bb |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.