Bismuth Subsalicylate Capsules 262 mg

Manufacturer
Softgel Healthcare Pvt Ltd
Effective date
2026-01-27
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:34:51

Label at a glance#

ProductBismuth subsalicylate
Active ingredientBISMUTH SUBSALICYLATE
Label structure15 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 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 ...

Label contents#

Full prescribing information#

Active ingredient (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Bismuth subsalicylate 262 mg

Purpose

OTC - PURPOSE SECTION

Upset stomach reliever and antidiarrheal

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 Reye’s syndrome:

WARNINGS 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 Reye’s syndrome, a rare but serious illness.

Allergy alert:

WARNINGS SECTION

Contains salicylate. Do not take if you are

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

Do not use if

OTC - DO NOT USE SECTION

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

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

If pregnant or breast feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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 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 102 mg
  • low sodium
  • do not exceed 25°C

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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-130335916023417GTIN-13: 0335916023417
EAN-13: 0335916023417
GTIN-12: 335916023417
UPC-A: 335916023417
GTIN storage (14 digits): 00335916023417
Bismuth Subsalicylate Capsules-carton.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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
35916-0234-1Bismuth subsalicylate1 in 1 CARTONCAPSULE, LIQUID FILLED12
35916-0234-1Bismuth subsalicylate10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED102

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
35916-023435916-0234-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 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
Bismuth subsalicylateBISMUTH SUBSALICYLATESoftgel Healthcare Pvt Ltd18f59606-1498-bd0c-e063-6394a90a7df22026-01-27WarningsExact identifier
ndc (package): 35916-0234-1
ndc (product): 35916-0234
ndc11 (package): 35916023401
spl id: 495a7b34-57db-3f94-e063-6394a90ad088
spl set id: 18f59606-1498-bd0c-e063-6394a90a7df2

Reported adverse events (FAERS/openFDA)#

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