FDA.reportPublic FDA data

Bismuth Subsalicylate

Manufacturer
LEADER/ Cardinal Health 110, Inc.
Effective date
2025-02-11
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:54:59

Label at a glance#

ProductBismuth Subsalicylate
Active ingredientBISMUTH SUBSALICYLATE
Label structure10 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 caplets with water, do not chew adults and children 12 years and over : 2 caplets (1 dose) every 1/2 hour or 4 caplets (2 doses) every hour as needed for diarrhea 2 caplets (1 dose) every 1/2 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea) do not exceed 8 doses (16 caplets) in 24 hours use until diarrhea stops but not more than 2 days children under 12 years : ask a doctor...

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each caplet)
Bismuth subsalicylate 262 mg

OTC - PURPOSE SECTION

Purpose
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 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

  • 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.

OVERDOSAGE SECTION

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • swallow caplets with water, do not chew

adults and children 12 years and over:

  • 2 caplets (1 dose) every 1/2 hour or 4 caplets (2 doses) every hour as needed for diarrhea
  • 2 caplets (1 dose) every 1/2 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
  • do not exceed 8 doses (16 caplets) 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 caplet contains: salicylate 102 mg
  • Store in a dry place at 15° – 30°C (59° – 86°F)
  • TAMPER EVIDENT: do not use if printed seal under cap is torn or missing

INACTIVE INGREDIENT SECTION

croscarmellose sodium, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, povidone, silica, sodium lauryl sulfate, stearic acid, talc, titanium dioxide, triacetin.

Questions or comments?

OTC - QUESTIONS SECTION

1-800-231-4670

SPL UNCLASSIFIED SECTION

RETAIN THIS CARTON FOR FULL LABELING INFORMATION

WARNING: This product can expose you to chemicals including lead, which is known to the State of California to cause cancer and birth defects or other reproductive harm. For more information go to www.P65Warnings.ca.gov.

COMPARE TO PEPTO-BISMOL active ingredient*

*This product is not manufactured or distributed by Procter & Gamble Inc., the distributor of Pepto-Bismol®.

DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017
www.myleader.com
1-800-200-6313
Essential to Care™ since 1979
Product of Mexico

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Leader LabelLeader Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308760bismuth subsalicylate 262 MG Oral TabletPSN3
308760bismuth subsalicylate 262 MG Oral TabletSCD3

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
70000-0594-1Bismuth Subsalicylate24 in 1 BOTTLETABLET, FILM COATED243
70000-0594-1Bismuth Subsalicylate1 in 1 CARTONTABLET, FILM COATED13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0594BISMUTH SUBSALICYLATE TABLET, FILM COATED [LEADER/ CARDINAL HEALTH 110, INC.]3Current NDC, Legacy NDC, 2 package rows20250213_d4af6694-910c-da17-e053-2995a90a8454.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0594-1EA - Each70000-0594075ce35a-3736-44e9-9c4a-e4f50976df1912022-08-04

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
70000-059470000-0594-1

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
CROSPOVIDONE2S7830E561IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
TALC7SEV7J4R1UIACT
BISMUTH SUBSALICYLATE62TEY51RR1ACTIB
SODIUM LAURYL SULFATE368GB5141JIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
HYPROMELLOSES3NXW29V3WOIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
TRIACETINXHX3C3X673IACT
LIGHT MINERAL OILN6K5787QVPIACT
POVIDONE K30U725QWY32XIACT
STEARIC ACID4ELV7Z65APIACT
MAGNESIUM STEARATE70097M6I30IACT

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 SUBSALICYLATELEADER/ Cardinal Health 110, Inc.d4af6694-910c-da17-e053-2995a90a84542025-02-11WarningsExact identifier
ndc (package): 70000-0594-1
ndc (product): 70000-0594
ndc11 (package): 70000059401
spl id: 2de450b8-01e2-0e3b-e063-6394a90af5f7
spl set id: d4af6694-910c-da17-e053-2995a90a8454

Reported adverse events (FAERS/openFDA)#

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