FDA.reportPublic FDA data

Stomach Relief

Manufacturer
Spirit Pharmaceuticals LLC
Effective date
2024-01-10
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:06:58

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: heartburn indigestion nausea gas belching fullness

Dosage and administration

swallow with water, do not chew adults and children 12 years and over:  2 softgels (1 dose) every 1/2 hour or 4 softgels (2 doses) every hour as needed for diarrhea 2 softgels (1 dose) every 1/2 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 dri...

Storage and handling

each softgel contains:  salicylate 99 mg n very low sodium store between 15-30°C (59-86°F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredient                                                                                Purpose

(in each softgel)

Bismuth subsalicylate 262 mg...............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

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

SPL UNCLASSIFIED SECTION

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

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • 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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • swallow with water, do not chew
  • adults and children 12 years and over:
  •  2 softgels (1 dose) every 1/2 hour or 4 softgels (2
    doses) every hour as needed for diarrhea
  • 2 softgels (1 dose) every 1/2 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

STORAGE AND HANDLING SECTION

  • each softgel contains:
  •  salicylate 99 mg n very low sodium
  • store between 15-30°C (59-86°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

SPL UNCLASSIFIED SECTION

aerosil, beeswax, FD&C Red#33. FD&C Yellow#6, gelatin, glycerin, light liquid paraffin, purified water, soya lecithin, sodium carboxy methyl
cellulose, sorbitol solution, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

1-888-333-9792

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Stomach Relief

BISMUTH SUBSALICYLATE
UPSET STOMACH RELIEVER / ANTIDIARRHEAL

25 CT / 75 CT

image descriptionimage description

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2121072bismuth subsalicylate 262 MG Oral CapsulePSN5
2121072bismuth subsalicylate 262 MG Oral CapsuleSCD5

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
68210-4092-1Stomach Relief75 in 1 BOTTLECAPSULE, LIQUID FILLED755
68210-4092-2Stomach Relief25 in 1 BOTTLECAPSULE, LIQUID FILLED255
68210-4092-2Stomach Relief1 in 1 CARTONCAPSULE, LIQUID FILLED15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68210-4092STOMACH RELIEF (BISMUTH SUBSALICYLATE) CAPSULE, LIQUID FILLED [SPIRIT PHARMACEUTICALS LLC]5Legacy NDC, 3 package rows20240111_a304fddd-7d4f-4c0b-b51f-46de19733e3d.zip

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
68210-409268210-4092-2, 68210-4092-1

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
SILICON DIOXIDEETJ7Z6XBU4IACT
YELLOW WAX2ZA36H0S2VIACT
D&C RED NO. 339DBA0SBB0LIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
PARAFFINI9O0E3H2ZEIACT
WATER059QF0KO0RIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMK679OBS311IACT
SORBITOL506T60A25RIACT
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
0e9c8e78-4ba1-4ade-e063-6394a90a8fffa304fddd-7d4f-4c0b-b51f-46de19733e3d2024-01-10WarningsExact identifier
spl id: 0e9c8e78-4ba1-4ade-e063-6394a90a8fff
spl set id: a304fddd-7d4f-4c0b-b51f-46de19733e3d

Reported adverse events (FAERS/openFDA)#

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