FDA.reportPublic FDA data

Stomach Relief Bismuth Subsalicylate 262 mg Chewable Tablets 30 Counts

Manufacturer
SAFEWAY
Effective date
2025-10-29
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:41:31

Label at a glance#

ProductStomach Relief
Active ingredientBISMUTH SUBSALICYLATE
Label structure10 sections

Indications and uses

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

Dosage and administration

chew completely or dissolve tablets in mouth. Do not swallow tablets whole. adults and children 12 years and over: 2 tablets (1 dose) every ½ hour to 1 hour or 4 tablets (2 doses) every hour as needed for diarrhea 2 tablets (1 dose) every ½ hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea) do not exceed 8 doses (16 tablets) in 24 hours use until diarrhea stops but not more than 2 da...

Storage and handling

each tablet contains: salicylate 102 mg Store at room temperature avoid excessive heat keep this carton for future reference on full labeling

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each chewable tablet)

OTC - ACTIVE INGREDIENT SECTION

Bismuth subsalicylate 262 mg

Purpose

OTC - PURPOSE SECTION

Antidiarrheal/ upset stomach reliever

Uses

INDICATIONS & USAGE SECTION

relieves

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

Warnings

WARNINGS SECTION

Reye's syndrome

SPL UNCLASSIFIED SECTION

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 or vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

Allergy alert

SPL UNCLASSIFIED SECTION

Do not use if you are

  • allergic to salicylate (including aspirin)
  • taking other salicylate products

OTC - DO NOT USE SECTION

Do not use ifyou have

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

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • fever
  • mucus in the stool

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you aretaking any drug for

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

OTC - WHEN USING SECTION

When using this producta temporary, but harmless, darkening of the stool and/or tongue may occur

OTC - STOP USE SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding,ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center immediately at 1-800-222-1222

Directions

DOSAGE & ADMINISTRATION SECTION

  • chew completely or dissolve tablets in mouth. Do not swallow tablets whole.
  • adults and children 12 years and over:
  • 2 tablets (1 dose) every ½ hour to 1 hour or 4 tablets (2 doses) every hour as needed for diarrhea
  • 2 tablets (1 dose) every ½ hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
  • do not exceed 8 doses (16 tablets) 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
  • children under 12 years:ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • each tablet contains: salicylate 102 mg
  • Store at room temperature
  • avoid excessive heat
  • keep this carton for future reference on full labeling

Inactive ingredients

INACTIVE INGREDIENT SECTION

D&C Red No. 27, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol, sucralose.

Questions or comments?

OTC - QUESTIONS SECTION

1-866-467-2748

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to the active ingredient in Pepto-Bismol® Chewables*

Stomach Relief

Chewable Tablets

Upset Stomach Reliever/Antidiarrheal

Original flavor

5 Symptoms Digestive Relief:

  • Heartburn
  • Indigestion
  • Nausea
  • Upset Stomach
  • Diarrhea

30 Chewable Tablets

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR OF STRIP UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

*This product is not manufactured or distributed by Procter & Gamble Inc., the distributor of Pepto-Bismol® Chewables.

Distributed by:

Stomach Relief BISMUTH SUBSAQLICYLATE
Stomach Relief BISMUTH SUBSAQLICYLATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308761bismuth subsalicylate 262 MG Chewable TabletPSN6
308761bismuth subsalicylate 262 MG Chewable TabletSCD6

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130321130781608GTIN-13: 0321130781608
EAN-13: 0321130781608
GTIN-12: 321130781608
UPC-A: 321130781608
GTIN storage (14 digits): 00321130781608		pepto-bismol-01.jpg

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21130-241-30Stomach Relief6 in 1 BLISTER PACKTABLET, CHEWABLE66
21130-241-30Stomach Relief5 in 1 CARTONTABLET, CHEWABLE56

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
21130-24121130-241-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
D&C RED NO. 272LRS185U6KIACT
MAGNESIUM STEARATE70097M6I30IACT
MALTODEXTRIN7CVR7L4A2DIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
SORBITOL506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT
BISMUTH SUBSALICYLATE62TEY51RR1ACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
52024-11-04full-release2026-06-01 00:33:59

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 SUBSALICYLATESAFEWAYba698d38-83f1-4257-9c43-e7a55dbb206e2025-10-29WarningsExact identifier
ndc (package): 21130-241-30
ndc (product): 21130-241
ndc11 (package): 21130024130
spl id: 424a99b0-ae2e-dda5-e063-6294a90ad311
spl set id: ba698d38-83f1-4257-9c43-e7a55dbb206e

Reported adverse events (FAERS/openFDA)#

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