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
- P & L Development, LLC
- Effective date
- 2025-01-28
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 5
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 20:41:46
Label at a glance#
ProductStomach Relief Ultra Strength
Active ingredientBISMUTH SUBSALICYLATE
Label structure10 sections
Dosage and administration
do not take more than 8 doses (120 mL) in 24 hours use until diarrhea stops but not more than 2 days drink plenty of clear fluids to help prevent dehydration caused by diarrhea 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: 15 mL (1 dose) every 1/2 hour or 30 mL (2 doses) every hou...
Storage and handling
each 15 mL contains : sodium 5 mg each 15 mL contains : salicylate 206 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 15 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 (1-800-222-1222) right away.
Directions
- do not take more than 8 doses (120 mL) in 24 hours
- use until diarrhea stops but not more than 2 days
- drink plenty of clear fluids to help prevent dehydration caused by diarrhea
- 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:
- 15 mL (1 dose) every 1/2 hour or 30 mL (2 doses) every hour as needed for diarrhea/traveler's diarrhea
- 15 mL (1 dose) every 1/2 as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
- children under 12 years of age: ask a doctor
Other information
- each 15 mL contains: sodium 5 mg
- each 15 mL contains: salicylate 206 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, glycerin, purified water, sucralose, xanthan gum
Questions or comments?
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Principal Display Panel
Compare to the active ingredient in Pepto-Bismol® Ultra*
Ultra Stomach Relief
Bismuth subsalicylate 525 mg
upset stomach reliever/antidiarrheal
Relieves:
- heartburn
- indigestion
- nausea
- upset stomach
- diarrhea
2x strength per ounce†
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.
Manufactured by:
PL Developments
11865 S. Alameda St
Lynwood, CA 90262
Package Label
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 49580-0737 | STOMACH RELIEF ULTRA STRENGTH (BISMUTH SUBSALICYLATE) LIQUID [P & L DEVELOPMENT, LLC] | 5 | Legacy NDC | 20250130_7d40e45c-2e20-4137-a16b-76407b073da1.zip |
Products#
Every source-derived product name is available through these pages.
- Stomach Relief Ultra Strength
- Bismuth subsalicylate
- BISMUTH CATION
- BENZOIC ACID
- D&C RED NO. 22
- D&C RED NO. 28
- WATER
- GLYCERIN
- SUCRALOSE
- XANTHAN GUM
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 49580-0737 | 49580-0737-8 |
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 |
| WATER | 059QF0KO0R | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| XANTHAN GUM | TTV12P4NEE | 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 |
|---|---|---|---|---|---|---|
| 11f98a9d-6e89-4e22-9dfd-5c6bf00bc3ad | 7d40e45c-2e20-4137-a16b-76407b073da1 | 2025-01-28 | Warnings | 11f98a9d-6e89-4e22-9dfd-5c6bf00bc3ad 7d40e45c-2e20-4137-a16b-76407b073da1 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.