FDA.reportPublic FDA data

Stomach Relief

Manufacturer
QUALITY CHOICE (Chain Drug Marketing Association)
Effective date
2025-01-28
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 20:41:47

Label at a glance#

ProductStomach Relief Ultra
Active ingredientBISMUTH SUBSALICYLATE
Label structure10 sections

Indications and uses

relieves travelers' diarrhea diarrhea upset stomach due to overindulgence in food and drink, including: heartburn gas indigestion nausea fullness belching

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 cause by diarrhea mL = mililiter shake well before using measure only with dosing cup provided. Do not use any other dosing device keep dosing cup with product  adults and children12 years and over: 15 mL (1 dose) every 1/2 hour or 30 mL (2 doses) every hour ...

Storage and handling

each 15 mL contains : sodium 6 mg each 15 mL contains : salicylate 227 mg low sodium keep tightly closed protect from freezing avoid excessive heat (over 104ºF or 40ºC)

Label contents#

Full prescribing information#

Active ingredient (in each 15 mL)

OTC - ACTIVE INGREDIENT SECTION

Bismuth subsalicylate 525 mg

Purpose

OTC - PURPOSE SECTION

Upset stomach reliever/Antidiarrheal

Uses

INDICATIONS & USAGE SECTION

relieves

  • travelers' diarrhea
  • diarrhea
  • upset stomach due to overindulgence in food and drink, including:
    • heartburn
    • gas
    • indigestion
    • nausea
    • fullness
    • belching

Warnings

WARNINGS SECTION

 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

OTC - DO NOT USE SECTION

if you have

  • an ulcer
  • a bleeding problem
  • bloody or black stool

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • fever
  • mucus in the stool

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking any drug for

  • diabetes
  • gout
  • arthritis
  • anticoagulation (thinning the blood)

When using this product

OTC - WHEN USING SECTION

a temporary, but harmless, darkening of the stool and/or tongue may occur.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of childen.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Posion Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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 cause by diarrhea
  • mL = mililiter
  • shake well before using
  • measure only with dosing cup provided. Do not use any other dosing device
  • keep dosing cup with product 
    • adults and children12 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 hour as needed for overindulgence (upset stomach, heartburn, indigestion,nausea)
  • children under 12 years of age: ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • each 15 mL contains: sodium 6 mg
  • each 15 mL contains: salicylate 227 mg
  • low sodium
  • keep tightly closed
  • protect from freezing
  • avoid excessive heat (over 104ºF or 40ºC)

Inactive ingredients

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

Call 1-800-935-2362 Monday-Friday 9AM-5PM EST

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

*Compare to the Active Ingredient IN Pepto-Bismol® Ultra

Ultra

Stomach Relief

Stomach Relief 

Bismuth subsalicylate | Upset Stomach Reliever/Antidiarrheal

For Relief of:

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.

Distributed by C.D.M.A., Inc.©

43157 W 9 Mile Rd

Novi, MI 48375

www.qualitychoice.com

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

QUALITY CHOICE Ultra Stomach Relief
QUALITY CHOICE Ultra Stomach Relief

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63868-814-082023-05-10C16284748780-1f386c649-9b64-0266-e053-dadaa90a7c1aDrug Facts
63868-814-082023-01-30C16284748780-1f386c649-9b64-0266-e053-dadaa90a7c1aDrug Facts

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-814STOMACH RELIEF ULTRA (BISMUTH SUBSALICYLATE) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]4Legacy NDC20250130_d8944d95-fa71-4362-8fcd-bf3c48b87ca5.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63868-81463868-814-08

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
BISMUTH SUBSALICYLATE62TEY51RR1ACTIB
BENZOIC ACID8SKN0B0MIMIACT
D&C RED NO. 221678RKX8RTIACT
D&C RED NO. 28767IP0Y5NHIACT
MAGNESIUM ALUMINUM SILICATE6M3P64V0NCIACT
WATER059QF0KO0RIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SALICYLIC ACIDO414PZ4LPZIACT
SODIUM SALICYLATEWIQ1H85SYPIACT
SORBIC ACIDX045WJ989BIACT
METHYLCELLULOSE (1500 CPS)P0NTE48364IACT

Source Document#

Source XML

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
780ab6e6-be6a-4ffc-a8cf-970e38cbc051d8944d95-fa71-4362-8fcd-bf3c48b87ca52025-01-28WarningsExact identifier
spl id: 780ab6e6-be6a-4ffc-a8cf-970e38cbc051
spl set id: d8944d95-fa71-4362-8fcd-bf3c48b87ca5

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.