FDA.reportPublic FDA data

Chewable Stomach Relief

Manufacturer
PUBLIX SUPER MARKETS INC,
Effective date
2025-10-28
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 01:40:56

Label at a glance#

ProductChewable Stomach 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 or dissolve tablets in mouth adults and children 12 years and over: 2 tablets every 1/2 to 1 hour as needed 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

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 or dissolve tablets in mouth
  • adults and children 12 years and over:2 tablets every 1/2 to 1 hour as needed
  • 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 toactive ingredient in Pepto-Bismol® Chewable Tablets*

Pink bismuth chewable tablets

Original flavor

BISMUTH SUBSALICYLATE 262 mg

ANTIDIARRHEAL/ UPSET STOMACH RELIEVER

Soothing relief for:

  • Heartburn
  • Indigestion
  • Upset Stomach
  • Nausea Diarrhea

30 CHEWABLE TABLETS

DO NOT USE IF INDIVIDUAL BLISTER COMPARTMENTS ARE TORN OR OPEN

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

DISTRIBUTED BY PUBLIX SUPER MARKETS, INC.

3300 PUBLIX CORPORATE PARKWAY

LAKELAND, FL 33811

Publix.com

Stomach Relief BISMUTH SUBSAQLICYLATE
Stomach Relief BISMUTH SUBSAQLICYLATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308761bismuth subsalicylate 262 MG Chewable TabletPSN8
308761bismuth subsalicylate 262 MG Chewable TabletSCD8

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0be8e4ae-4d57-49f3-b3a9-e4728b4e8d15Product name120240313
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41415-124-30Chewable Stomach Relief6 in 1 BLISTER PACKTABLET, CHEWABLE68
41415-124-30Chewable Stomach Relief5 in 1 CARTONTABLET, CHEWABLE58

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
41415-12441415-124-30

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
72024-10-29full-release2026-06-01 00:31:17

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
Chewable Stomach ReliefBISMUTH SUBSALICYLATEPUBLIX SUPER MARKETS INC,2a316e06-5c16-46b8-b9ac-71fe0f92c5152025-10-28WarningsExact identifier
ndc (package): 41415-124-30
ndc (product): 41415-124
ndc11 (package): 41415012430
spl id: 4236b5e2-dc5d-2ae7-e063-6294a90aa984
spl set id: 2a316e06-5c16-46b8-b9ac-71fe0f92c515

Reported adverse events (FAERS/openFDA)#

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