FDA.reportPublic FDA data

Bismuth Subsalicylate

Manufacturer
Spirit Pharmaceuticals LLC
Effective date
2024-12-11
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:42:29

Label at a glance#

ProductBismuth Subsalicylate
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 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 cle...

Storage and handling

each softgel contains: salicylate 102 mg very low sodium  do not exceed 25°C

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredient ( in each softgel)                        Purpose

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: Contains salicylate. Do not take if you are

SPL UNCLASSIFIED SECTION

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

Do not use if you have

OTC - DO NOT USE SECTION

  • 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

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking any drug for

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

When using this product

OTC - WHEN USING SECTION

  • 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 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

STORAGE AND HANDLING SECTION

  • each softgel contains: salicylate 102 mg
  • very low sodium
  •  do not exceed 25°C

Inactive ingredients

INACTIVE INGREDIENT 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 262 mg
Upset Stomach Reliever/Antidiarrheal

Soothing relief for 5 symptoms:
• Heartburn • Indigestion • Upset stomach
• Nausea • Diarrhea

12 Softgels

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
68210-4152-1Bismuth Subsalicylate1 in 1 CARTONCAPSULE, GELATIN COATED15
68210-4152-1Bismuth Subsalicylate12 in 1 BLISTER PACKCAPSULE, GELATIN COATED125

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68210-4152BISMUTH SUBSALICYLATE CAPSULE, GELATIN COATED [SPIRIT PHARMACEUTICALS LLC]5Legacy NDC, 2 package rows20241213_86e7d60c-6900-46b4-9c70-c0d8fb6bd420.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68210-415268210-4152-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
SILICON DIOXIDEETJ7Z6XBU4IACT
LECITHIN, SOYBEAN1DI56QDM62IACT
YELLOW WAX2ZA36H0S2VIACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT
LIGHT MINERAL OILN6K5787QVPIACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
D&C RED NO. 339DBA0SBB0LIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
WATER059QF0KO0RIACT
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
2900d9b1-645d-33a8-e063-6394a90a032286e7d60c-6900-46b4-9c70-c0d8fb6bd4202024-12-11WarningsExact identifier
spl id: 2900d9b1-645d-33a8-e063-6394a90a0322
spl set id: 86e7d60c-6900-46b4-9c70-c0d8fb6bd420

Reported adverse events (FAERS/openFDA)#

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