FDA.reportPublic FDA data

Gastrobiz

Manufacturer
Allegiant Health
Effective date
2018-09-11
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 01:33:20

Label at a glance#

ProductGastrobiz
Active ingredientBISMUTH SUBSALICYLATE
Label structure8 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

chew or dissolve in mouth Adults and children 12 years and over: 2 tablets (1 dose) every ½ hour or 4 tablets (2 doses) every hour as needed for diarrhea 2 tablets (1 dose) every 1/2 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea) do not exceed 8 doses (16 tablets) in 24 hours use until diarrhea stops but not more than 2 days Children under 12 years of age: ask a doctor drink plen...

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

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: 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

OTC - DO NOT USE SECTION

if you have

  • an ulcer
  • a bleeding problem
  • bloody or black stool

Ask a doctor before use if

OTC - ASK DOCTOR SECTION

you have

  • fever
  • mucus in the stool

Ask a doctor or pharmacist before use if

OTC - ASK DOCTOR/PHARMACIST SECTION

you are taking any 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 or last more than 2 days
  • ringing in the ears or loss of hearing occurs
  • diarrhea lasts more than 2 days

Pregnancy/Breastfeeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, 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, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • chew or dissolve in mouth
  • Adults and children 12 years and over: 2 tablets (1 dose) every ½ hour or 4 tablets (2 doses) every hour as needed for diarrhea
  • 2 tablets (1 dose) every 1/2 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
  • do not exceed 8 doses (16 tablets) in 24 hours
  • use until diarrhea stops but not more than 2 days
  • Children under 12 years of age: ask a doctor
  • drink plenty of clear fluids to help prevent dehydration caused by diarrhea

Other information

SPL UNCLASSIFIED SECTION

  • Phenylketonurics: contains phenylalanine 1.1mg per tablet
  • Each tablet contains: calcium 73mg
  • save carton for full directions and warnings
  • store at room temperature 15°– 30°C (59°– 86°F)
  • avoid excessive heat (over 40°C or 104°F)
  • do not use if cellophane unit is torn
  • you may report side effects to 1888-952-0050

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

SUMMR®

Compare to Pepto Bismol® Active Ingredient

Gastrobiz

Bismuth Subsalicylate 262 mg

UPSET STOMACH RELIEVER/ANTI-DIARRHEAL

PROTECTIVE COATING ACTION

LOW SODIUM

30 CHEWABLE TABLETS

PEPPERMINT FLAVOR

Gastrobiz
Gastrobiz

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308761bismuth subsalicylate 262 MG Chewable TabletPSN9
308761bismuth subsalicylate 262 MG Chewable TabletSCD9

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130712038319756GTIN-13: 0712038319756
EAN-13: 0712038319756
GTIN-12: 712038319756
UPC-A: 712038319756
GTIN storage (14 digits): 00712038319756		gastrobiz-bismuth-subsalicylate-262mg-1.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69168-999-982020-03-13C16284748780-19d75b9d0-38d1-f424-e053-dadaa90a57ceGastrobiz Bismuth Subsalicylate 262mg
69168-999-982020-01-31C16284748780-19d75b9d0-38d1-f424-e053-dadaa90a57ceGastrobiz Bismuth Subsalicylate 262mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69168-999-98Gastrobiz1 in 1 CELLO PACKTABLET, CHEWABLE19
69168-999-98Gastrobiz30 in 1 CARTONTABLET, CHEWABLE309

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
69168-99969168-999-98

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
BISMUTH SUBSALICYLATE62TEY51RR1ACTIB
ACACIA5C5403N26OIACT
ASPARTAMEZ0H242BBR1IACT
CALCIUM CARBONATEH0G9379FGKIACT
D&C RED NO. 272LRS185U6KIACT
DEXTRATESG263MI44RUIACT
MAGNESIUM STEARATE70097M6I30IACT
MALTODEXTRIN7CVR7L4A2DIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
PEPPERMINTV95R5KMY2BIACT
SILICON DIOXIDEETJ7Z6XBU4IACT

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
GastrobizBISMUTH SUBSALICYLATEAllegiant Healthaa516512-afd7-453f-9c73-5fa930cafac32018-09-11WarningsExact identifier
ndc (package): 69168-999-98
ndc (product): 69168-999
ndc11 (package): 69168099998
spl id: b84b5c7b-afd7-4d0c-8db6-eda1bf813a75
spl set id: aa516512-afd7-453f-9c73-5fa930cafac3

Reported adverse events (FAERS/openFDA)#

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