FDA.reportPublic FDA data

Stomach Relief

Manufacturer
CVS
Effective date
2017-08-08
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:52:09

Label at a glance#

ProductStomach Relief
Active ingredientBISMUTH SUBSALICYLATE
Label structure8 sections

Indications and uses

relieves: diarrhea heartburn indigestion nausea upset stomach associated with these symptoms

Dosage and administration

shake well before use mL = milliliter TBSP =tablespoon adults and children 12 years and over: 1 dose (2 tbsp or 30 mL) every 1/2 to 1 hour as needed do not exceed 8 doses (16 tbsp or 240 mL) in 24 hours use until diarrhea stops but not more than 2 days children under 12 years: ask a doctor drink plenty of clear fluids to help prevent dehydration caused by diarrhea

Storage and handling

each 30 mL or 2 Tbsp contains: sodium 8 mg, salicylate 260 mg, potassium 25 mg protect from freezing avoid excessive heat (over 104 o F or 40 o C) dosage cup provided

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 and anti-diarrheal

Uses

INDICATIONS & USAGE SECTION

relieves:

  • diarrhea
  • heartburn
  • indigestion
  • nausea
  • upset stomach associated with these symptoms

Warnings

WARNINGS SECTION

Reye's syndrome: Children and teenagers who have or are recovering from children 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

OTC - DO NOT USE SECTION

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

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 taking any drug for

OTC - ASK DOCTOR/PHARMACIST SECTION

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

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
  • 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 children.

OTC - PREGNANCY OR BREAST FEEDING SECTION

In case of overdose, get medical help or contact a Poison control center  immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • shake well before use
  • mL = milliliter
  • TBSP =tablespoon
  • adults and children 12 years and over: 1 dose (2 tbsp or 30 mL) every 1/2 to 1 hour as needed
  • do not exceed 8 doses (16 tbsp or 240 mL) in 24 hours
  • use until diarrhea stops but not more than 2 days
  • children under 12 years: ask a doctor
  • drink plenty of clear fluids to help prevent dehydration caused by diarrhea

Other information

STORAGE AND HANDLING SECTION

  • each 30 mL or 2 Tbsp contains: sodium 8 mg, salicylate 260 mg, potassium 25 mg
  • protect from freezing
  • avoid excessive heat (over 104oF or 40oC)
  • dosage cup provided

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzoic acid, D&C red 22, D&C red 28, flavor, hydroxy ethyl cellulose, potassium hydroxide, purified water, saccharin sodium, salicylic acid, simethicone, xanthan gum.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

*Compare to the active ingredient in PEPTO-BISMOL®

CVS Health

Original Stomach Relief

Bismuth Subsalicylate 525 mg

Upset stomach reliever & Anti-Diarrheal

Soothing Relief for 5 symptoms:  

Upset Stomach

Indigestion

Nausea

Heartburn

Diarrhea

8 FL OZ (236 mL) CVS 527.jpg.jpg

LabelLabel

LabelLabel

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BISMUTH CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130012345678905GTIN-13: 0012345678905
EAN-13: 0012345678905
GTIN-12: 012345678905
UPC-A: 012345678905
GTIN storage (14 digits): 00012345678905		CVS 527.jpg.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0be8e4ae-4d57-49f3-b3a9-e4728b4e8d15Product name120240313
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69842-527-032024-01-30C16284748780-11030e365-1ae1-111a-e063-dadaa90a10e2Original Stomach Relief
69842-527-042024-01-30C16284748780-11030e365-1ae1-111a-e063-dadaa90a10e2Original Stomach Relief
69842-527-062024-01-30C16284748780-11030e365-1ae1-111a-e063-dadaa90a10e2Original Stomach Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69842-527-03Stomach Relief118 mL in 1 BOTTLELIQUID1182
69842-527-04Stomach Relief236 mL in 1 BOTTLELIQUID2362
69842-527-06Stomach Relief473 mL in 1 BOTTLELIQUID4732

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-527STOMACH RELIEF (BISMUTH SUBSALICYLATE) LIQUID [CVS]2Legacy NDC, 3 package rows20170808_fb15466c-c99a-4929-8ce9-8a7d2214fc35.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
69842-52769842-527-04, 69842-527-03, 69842-527-06

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
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)S38J6RZN16IACT
POTASSIUM HYDROXIDEWZH3C48M4TIACT
WATER059QF0KO0RIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SALICYLIC ACIDO414PZ4LPZIACT
DIMETHICONE92RU3N3Y1OIACT
XANTHAN GUMTTV12P4NEEIACT

Source Document#

Source XML · Source PDF

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
6cf49a02-536a-47f0-8b83-8149744b7c91fb15466c-c99a-4929-8ce9-8a7d2214fc352017-08-08WarningsExact identifier
spl id: 6cf49a02-536a-47f0-8b83-8149744b7c91
spl set id: fb15466c-c99a-4929-8ce9-8a7d2214fc35

Reported adverse events (FAERS/openFDA)#

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