FDA.reportPublic FDA data

Bismuth Chewable

Manufacturer
Marc Glassman, Inc.
Effective date
2016-12-19
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-05-31 23:56:53

Label at a glance#

ProductBismuth Chewable
Active ingredientBISMUTH SUBSALICYLATE
Label structure8 sections

Indications and uses

■ controls diarrhea    ■ relieves heartburn, indigestion, nausea and upset stomach

Dosage and administration

■ drink plenty of clear fluids to help revent deydration caused by diarrhea  ■  Adults and children 12 years and over: 2 tablets every ½ to 1 hour or 4 tablets every hour as needed ■ do not exceed 16 tablets in 24 hours   ■ use until diarrhea stops but no more than 2 days  ■  Children under 12 years of age: ask a doctor

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

 Bismuth subsalicylate 262mg (each tablet contains 102mg salicylate)

Purpose

OTC - PURPOSE SECTION

Antidiarrheal/Antacid

Uses

INDICATIONS & USAGE SECTION

■ controls diarrhea   

■ relieves heartburn, indigestion, nausea and upset stomach

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

Do not use if you have

OTC - DO NOT USE SECTION

■ bloody or black stool  

■ an ulcer 

■ a bleeding problem

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

OTC - ASK DOCTOR/PHARMACIST SECTION

you are taking a drug for  

■ anticoagulation (thinning of 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  

■ ringing in the ears or loss of hearing occurs  

■ diarrhea lasts for more than 2 days

Pregnancy/Breastfeeding

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 accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

■ drink plenty of clear fluids to help revent deydration caused by diarrhea 

■ Adults and children 12 years and over: 2 tablets every ½ to 1 hour or 4 tablets every hour as needed

■ do not exceed 16 tablets in 24 hours  

■ use until diarrhea stops but no more than 2 days 

■ Children under 12 years of age: ask a doctor

Other information

SPL UNCLASSIFIED SECTION

■ Phenylketonurics: contains phenylalanine 1.1mg per tablet  

■ Calcium content per tablet: 73mg  

■ save carton for full directions and warnings   

■ store at room temperature  15°– 30°C (59°– 86°F)    

■ do not use if cellophane unit is torn

Inactive ingredients

INACTIVE INGREDIENT SECTION

acacia gum, aspartame, calcium carbonate, D&C red # 27 aluminum lake, dextrates, magnesium stearate, maltodextrin, microcrystalline cellulose, peppermint flavor, silicon dioxide

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BismuthBismuth 

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308761bismuth subsalicylate 262 MG Chewable TabletPSN7
308761bismuth subsalicylate 262 MG Chewable TabletSCD7

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
68998-046-88Bismuth Chewable1 in 1 CELLO PACKTABLET, CHEWABLE17
68998-046-88Bismuth Chewable30 in 1 CARTONTABLET, CHEWABLE307

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68998-046BISMUTH CHEWABLE (BISMUTH SUBSALICYLATE 262 MG) TABLET, CHEWABLE [MARC GLASSMAN, INC.]7Current NDC, Legacy NDC, 2 package rows20231018_cdfcfdc2-ed5e-49d8-b16f-e32748d82e3e.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68998-04668998-046-88

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
BISMUTH SUBSALICYLATE62TEY51RR1ACTIB
ASPARTAMEZ0H242BBR1IACT
CALCIUM CARBONATEH0G9379FGKIACT
D&C RED NO. 272LRS185U6KIACT
DEXTRATESG263MI44RUIACT
MAGNESIUM STEARATE70097M6I30IACT
MALTODEXTRIN7CVR7L4A2DIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
SILICON DIOXIDEETJ7Z6XBU4IACT

Source Document#

Source XML · Source PDF

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 ChewableBISMUTH SUBSALICYLATE 262 MGMarc Glassman, Inc.cdfcfdc2-ed5e-49d8-b16f-e32748d82e3e2016-12-19WarningsExact identifier
ndc (package): 68998-046-88
ndc (product): 68998-046
ndc11 (package): 68998004688
spl id: 81a0328d-4a00-4331-b9c3-aaedaf455e51
spl set id: cdfcfdc2-ed5e-49d8-b16f-e32748d82e3e

Reported adverse events (FAERS/openFDA)#

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