Stomach Relief

Manufacturer
Shield Pharmaceuticals Corp
Effective date
2025-11-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:43:20

Label at a glance#

ProductStomach Relief
Active ingredientBISMUTH
Label structure18 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

• swallow with water, do not chew • adults and children 12 years and over: • 2 softgels every ½ hour or 4 softgels every hour as needed for diarrhea • 2 softgels every ½ hour to 1 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea) • do not exceed 8 doses (16 softgels) in 24 hours • use until diarrhea stops but not more than 2 days • children under 12 years: ask a doctor • drink plent...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Bismuth subsalicylate 262 mg

Purpose

OTC - PURPOSE SECTION

Upset stomach reliever and anti-diarrheal

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: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

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

• 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

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 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 (1-800-222-1222) right away. Quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

• swallow with water, do not chew
• adults and children 12 years and over:
• 2 softgels every ½ hour or 4 softgels every hour as needed for diarrhea
• 2 softgels every ½ hour to 1 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
• do not exceed 8 doses (16 softgels) 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

OTHER SAFETY INFORMATION

• each softgel contains: salicylate 99 mg
• very low sodium
• store between 20-25° C (68-77° F)

Questions or comments?

OTC - QUESTIONS SECTION

1-800-373-6981 (toll-free)

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

SPL UNCLASSIFIED SECTION

Distributed by:
Shield Pharmaceuticals Corp.
Ronkonkoma, NY 11779

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ValuRx

Compare to the active ingredient in Pepto-Bismol® LiquicapsTM†

Stomach Relief
Bismuth Subsalicylate
Upset Stomach Reliever/Antidiarrheal
Soothing Relieves of 5 Symptoms:
• Nausea
• Heartburn
• Indigestion
• Upset Stomach
• Diarrhea

Carton

CartonCarton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2121072bismuth subsalicylate 262 MG Oral CapsulePSN2
2121072bismuth subsalicylate 262 MG Oral CapsuleSCD2

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130611419406200GTIN-13: 0611419406200
EAN-13: 0611419406200
GTIN-12: 611419406200
UPC-A: 611419406200
GTIN storage (14 digits): 00611419406200
Carton.jpg
QR code linkQR Codewww.shieldpharmacorp.com/Carton.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83059-0111-8Stomach Relief8 in 1 BLISTER PACKCAPSULE, LIQUID FILLED82
83059-0111-8Stomach Relief1 in 1 CARTONCAPSULE, LIQUID FILLED12

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
83059-011183059-0111-8

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

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
579b5294-4e5f-770a-e063-6394a90adf899ae1bcd1-30c3-40f3-87e6-633c19d72cb22026-07-27WarningsExact identifier
spl set id: 9ae1bcd1-30c3-40f3-87e6-633c19d72cb2

Reported adverse events (FAERS/openFDA)#

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