Stomach Relief

Manufacturer
QUALITY CHOICE (Chain Drug Marketing Association)
Effective date
2024-10-31
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 20:50:39

Label at a glance#

ProductStomach Relief
Active ingredientBISMUTH SUBSALICYLATE
Label structure10 sections

Indications and uses

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

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 adult and children 12 years and over: 30 mL (1 dose) every 1/2 or 60 mL (2 doses) every hour as needed for diarrhea/traveler's diarrhea 30 mL (1 dose) every 1/2 hour as needed for overindulgence (unset stomach, heartburn, indigestion, nausea) do not exceed 8 doses (240 mL) ...

Storage and handling

each 30 mL  contains : sodium 11 mg each 30 mL  contains : salicylate 206 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 30 mL)

OTC - ACTIVE INGREDIENT SECTION

Bismuth subsalicylate 525 mg

Purpose

OTC - PURPOSE SECTION

Upset stomach reliever/Antidiarrheal

Uses

INDICATIONS & USAGE SECTION

relieves

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

Warnings

WARNINGS SECTION

 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

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

  • mL = milliliter
  • shake well before using
  • measure only with dosing cup provided. Do not use any other dosing device
  • keep dosing cup with product
  • adult and children 12 years and over:
    • 30 mL (1 dose) every 1/2 or 60 mL (2 doses) every hour as needed for diarrhea/traveler's diarrhea
    • 30 mL (1 dose) every 1/2 hour as needed for overindulgence (unset stomach, heartburn, indigestion, nausea)
    • do not exceed 8 doses (240 mL) in 24 hour
    • use until diarrhea stop but not more than 2 days
  • children under 12 years of age: ask a doctor
  • drink plenty of clear fluids to help prevent dehydration cause by diarrhea

Other information

STORAGE AND HANDLING SECTION

  • each 30 mL  contains: sodium 11 mg
  • each 30 mL  contains: salicylate 206 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, glycerin,purified water, sucralose, xanthan gum

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-Bismal®

Regular Strength

Stomach Relief

Stomach Relief

Bismuth Subsalicylate | Stomach Reliever,

Antidiarrheal

For Relief of:

heartburn

Indigestion

Nausea

Upset Stomach

Diarrhea

Alcohol Free

Sugar Free

Cherry Flavor

FL OZ (mL)

*This product is not manufactured or distributed by Procter & Gamble Company. Pepto-Bismol® is a registered trademark of th 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 Stomach Relief
QUALITY CHOICE Stomach Relief

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-832STOMACH RELIEF (BISMUTH SUBSALICYLATE) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]3Legacy NDC20241102_4db6aec7-48ab-40b5-9060-7a1a166bdebf.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-832-08ML - Milliliter63868-832fc519535-f9a3-468e-b199-b678a4f3e8c612022-10-06

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63868-83263868-832-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

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
471ae4ce-b3eb-43f2-8eec-f5136d5c2d574db6aec7-48ab-40b5-9060-7a1a166bdebf2024-10-31WarningsExact identifier
spl id: 471ae4ce-b3eb-43f2-8eec-f5136d5c2d57
spl set id: 4db6aec7-48ab-40b5-9060-7a1a166bdebf

Reported adverse events (FAERS/openFDA)#

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