FDA.reportPublic FDA data

Stomach Relief

Manufacturer
Wal-Mart Stores Inc | LNK International, Inc.
Effective date
2026-02-26
Label type
HUMAN OTC DRUG LABEL
Version
17
Source
full-release
Hydrated at
2026-06-01 01:47:23

Label at a glance#

ProductStomach Relief
Active ingredientBISMUTH SUBSALICYLATE
Label structure9 sections

Indications and uses

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

Dosage and administration

do not take more than directed swallow with water; do not chew drink plenty of clear fluids to help prevent dehydration caused by diarrhea adults and children 12 years and over: 2 caplets every ½ to 1 hour as needed. Do not exceed 8 doses (16 caplets) in 24 hours. do not use for more than 2 days unless directed by a doctor use until diarrhea stops, but not more than 2 days children under 12 years: ask a doctor

Storage and handling

each caplet contains: calcium 20 mg, salicylate 103 mg store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) avoid excessive heat see end flap for expiration date and lot number 

Label contents#

Full prescribing information#

Active ingredient (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Bismuth subsalicylate 262 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:
    • belching
    • indigestion
    • gas
    • fullness
    • heartburn
    • nausea

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

  • anticoagulation (thinning 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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use. 

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away. 

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than directed
  • swallow with water; do not chew
  • drink plenty of clear fluids to help prevent dehydration caused by diarrhea
  • adults and children 12 years and over: 2 caplets every ½ to 1 hour as needed. Do not exceed 8 doses (16 caplets) in 24 hours.
  • do not use for more than 2 days unless directed by a doctor
  • use until diarrhea stops, but not more than 2 days
  • children under 12 years: ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • each caplet contains: calcium 20 mg, salicylate 103 mg
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • avoid excessive heat
  • see end flap for expiration date and lot number 

Inactive ingredients

INACTIVE INGREDIENT SECTION

calcium carbonate, corn starch, D&C red #27 aluminum lake, D&C red #30 aluminum lake, magnesium stearate, mannitol, microcrystalline cellulose, povidone, silicon dioxide, sodium starch glycolate, stearic acid

Questions or comments?

OTC - QUESTIONS SECTION

1-888-287-1915

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

equate™

NDC 49035-346-10

Compare to
Pepto-Bismol®
active
ingredient*

Stomach
Relief
 Bismuth Subsalicylate
262 mg
Upset Stomach Reliever/
 Antidiarrheal

Relieves
• Nausea
• Heartburn
• Indigestion
• Upset stomach
• Diarrhea

262
mg
EACH 

40
CAPLETS

Actual Size

TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Satisfaction guaranteed - Or we'll replace it or
give you your money back. For questions or
comments please call 1-888-287-1915.

DISTRIBUTED BY: Walmart Inc.,
Bentonville, AR 72716
PRODUCT OF GERMANY AND MEXICO
*This product is not manufactured or distributed by The
Procter & Gamble Company, owner of the registered
trademark Pepto-Bismol®.     50844     REV0521B34610

Equate 44-346
Equate 44-346

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308760bismuth subsalicylate 262 MG Oral TabletPSN17
308760bismuth subsalicylate 262 MG Oral TabletSCD17

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-130681131280396GTIN-13: 0681131280396
EAN-13: 0681131280396
GTIN-12: 681131280396
UPC-A: 681131280396
GTIN storage (14 digits): 00681131280396		equate-44-346-1.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0be8e4ae-4d57-49f3-b3a9-e4728b4e8d15Product name120240313
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49035-346-10Stomach Relief1 in 1 CARTONTABLET117
49035-346-10Stomach Relief40 in 1 BOTTLE, PLASTICTABLET4017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49035-346-10EA - Each49035-3466a9f88d5-9214-4943-8877-8d5a6ef5d6cc12024-08-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BISMUTH SUBSALICYLATEACTIVE INGREDIENT62TEY51RR14
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZ4
CALCIUM CARBONATEINACTIVE INGREDIENTH0G9379FGK4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61U4
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6K4
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808B4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I304
MANNITOLINACTIVE INGREDIENT3OWL53L36A4
POVIDONESINACTIVE INGREDIENTFZ989GH94E4
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP4

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49035-34649035-346-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
BISMUTH SUBSALICYLATE62TEY51RR1ACTIB
CALCIUM CARBONATEH0G9379FGKIACT
STARCH, CORNO8232NY3SJIACT
D&C RED NO. 27 ALUMINUM LAKEZK64F7XSTXIACT
D&C RED NO. 30 ALUMINUM LAKEGE75M6YV5WIACT
MAGNESIUM STEARATE70097M6I30IACT
MANNITOL3OWL53L36AIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM STARCH GLYCOLATE TYPE A POTATO5856J3G2A2IACT
STEARIC ACID4ELV7Z65APIACT

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 16 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
D&C RED NO. 30D&C RED NO. 302S42T2808BTABLET / ORAL19 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ETABLET / ORAL216 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ATABLET / ORAL3391 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET / ORAL336 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ATABLET / ORAL3391 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / ORAL6184 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKTABLET / ORAL793 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
D&C RED NO. 30D&C RED NO. 302S42T2808BTABLET / ORAL19 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
D&C RED NO. 27D&C RED NO. 272LRS185U6KTABLET / ORAL1 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKTABLET / ORAL793 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
D&C RED NO. 27D&C RED NO. 272LRS185U6KTABLET / ORAL1 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET / ORAL336 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ETABLET / ORAL216 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / ORAL6184 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates

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
Stomach ReliefBISMUTH SUBSALICYLATEWal-Mart Stores Inc2d7d563e-4c46-4788-b6a7-5b92e3d585332026-02-26WarningsExact identifier
ndc (package): 49035-346-10
ndc (product): 49035-346
ndc11 (package): 49035034610
spl id: 57dddefe-483d-47c4-8a4a-461556ee1ea6
spl set id: 2d7d563e-4c46-4788-b6a7-5b92e3d58533

Reported adverse events (FAERS/openFDA)#

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