FDA.reportPublic FDA data

Stomach Relief

Manufacturer
Shield Pharmaceuticals Corp
Effective date
2026-01-26
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:34:54

Label at a glance#

ProductStomach Relief
Active ingredientBISMUTH SUBSALICYLATE
Label structure11 sections

Indications and uses

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

Dosage and administration

shake well before use only use dose cup provided adults and children 12 years and over: 30 mL (1 dose) every ½ hour or 60 mL (2 doses) every hour as needed for diarrhea/traveler's diarrhea 30mL (1 dose) every ½ hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea) do not exceed 8 doses (240 mL) in 24 hours use until diarrhea stops but not more than 2 days children under 12 years: ask a ...

Storage and handling

each 30 mL dose contains: magnesium 3 mg, sodium 4 mg salicylate 261 mg low sodium protect from freezing avoid excessive heat (over 104°F or 40°C) TAMPER EVIDENT: Do not use if printed shrinkband is missing or broken.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 30 mL Dose)

OTC - ACTIVE INGREDIENT SECTION

Bismuth subsalicylate 525 mg

Purpose

OTC - PURPOSE SECTION

Upset stomach reliever and antidiarrheal

Uses

INDICATIONS & USAGE SECTION

relieves

  • traveler's 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 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

SPL UNCLASSIFIED SECTION

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

OTC - DO NOT USE SECTION

Do not use if you 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 are taking any drug for

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

OTC - WHEN USING SECTION

When using this product 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

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, 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 right away (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

  • shake well before use
  • only use dose cup provided
  • adults and children 12 years and over:
  • 30 mL (1 dose) every ½ hour or 60 mL (2 doses) every hour as needed for diarrhea/traveler's diarrhea
  • 30mL (1 dose) every ½ hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
  • do not exceed 8 doses (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 dose contains:magnesium 3 mg, sodium 4 mg
  • salicylate 261 mg
  • low sodium
  • protect from freezing
  • avoid excessive heat (over 104°F or 40°C)

TAMPER EVIDENT:Do not use if printed shrinkband is missing or broken.

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C red #33, FD&C yellow #6, gelatin, glycerin, lecithin, polyethylene glycol-400, polysorbate 20, polysorbate 80, povidone, purified water, sorbitan, sorbitol solution, titanium dioxide

Questions?

OTC - QUESTIONS SECTION

1-800-373-6981

SPL UNCLASSIFIED SECTION

Distributed by:
Shield Pharmaceuticals Corp.Ronkonkoma, NY 11779

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label

Pepto Bismol 4 oz frontPepto Bismol 4 oz front

Pepto Bismol 4 oz backPepto Bismol 4 oz back

DailyMed Pharmacologic Classes#

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

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
83059-0126-4Stomach Relief118 mL in 1 BOTTLE, PLASTICLIQUID1182

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83059-012683059-0126-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
FD&C RED NO. 3PN2ZH5LOQYIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
POLYSORBATE 207T1F30V5YHIACT
POLYSORBATE 806OZP39ZG8HIACT
WATER059QF0KO0RIACT
POVIDONEFZ989GH94EIACT
SORBITAN6O92ICV9RUIACT
SORBITOL SOLUTION8KW3E207O2IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
BISMUTH SUBSALICYLATE62TEY51RR1ACTIB

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
57353bac-dfff-67a7-e063-6294a90a8cbb438c81e5-8b0d-4d7c-b8e3-a72877965dd52026-07-22WarningsExact identifier
spl set id: 438c81e5-8b0d-4d7c-b8e3-a72877965dd5

Reported adverse events (FAERS/openFDA)#

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