FDA.reportPublic FDA data

Crane Safety Bismuth

Manufacturer
Crane Safety LLC | Unifirst First Aid Corporation
Effective date
2022-06-23
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 21:58:17

Label at a glance#

ProductCrane Safety Bismuth
Active ingredientBISMUTH SUBSALICYLATE
Label structure16 sections

Indications and uses

Temporarily relieves traveler's diarrhea diarrhea upset stomach due to overindulgence in food and drink, including: heartburn indigestion nausea gas belching fullness

Dosage and administration

do not use more than directed chew or crush tablets completely befre swallowing do not swallow tablet whole use until diarrhea stops but not more than 2 days drink plenty of clear fluids to help prevent dehydration, which may accompany diarrhea do not exceed 16 tablets in 24 hours Adults and children: (12 years and older) Chew 2 tablets every 1/2 to 1 hour or 4 tablets every hour as needed Children under 12 year s...

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Bismuth Subsalicylate 262 mg

(each tablet contains 102 mg salicylate)

Purpose

OTC - PURPOSE SECTION

Upset stomach reliever/antidiarrheal

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves

  • traveler's 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 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 if you are taking any drug for

OTC - ASK DOCTOR/PHARMACIST SECTION

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

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 more than 2 days

When using this product

OTC - WHEN USING SECTION

a temporary and harmless darkening of the tongue and/or stool may occur. Stool darkening should not be confused with melena.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep this and all drugs out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental overdose, contact a physician or poison control center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not use more than directed
  • chew or crush tablets completely befre swallowing
  • do not swallow tablet whole
  • use until diarrhea stops but not more than 2 days
  • drink plenty of clear fluids to help prevent dehydration, which may accompany diarrhea
  • do not exceed 16 tablets in 24 hours

Adults and children: (12 years and older) Chew 2 tablets every 1/2 to 1 hour or 4 tablets every hour as needed

Children under 12 years: Do not give to children under 12 years of age.

Other information

OTHER SAFETY INFORMATION

  • phenylketonurics: contains phenylalanine 1.1mg per tablet
  • each tablet contains 73mg elemental calcium
  • store at room temperature 59º-86ºF (15º-30ºC)
  • tamper-evident sealed packets
  • do not use any opened or torn packets

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

877.506.4291

Crane Safety Bismuth Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Chewable

Bismuth Tabs

Upset Stomach/Diarrhea Relief

CRANE Safety®

Bismuth Subsalicylate 262 MG

Chew or Crush Tablets Completely Before Swallowing.

Do Not Swallow Tablets Whole.

36 Tablets

Tamper Evident

C BismuthC Bismuth

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
73408-40673408-406-20

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
BISMUTH SUBSALICYLATE62TEY51RR1ACTIB
D&C RED NO. 272LRS185U6KIACT
CALCIUM CARBONATEH0G9379FGKIACT
DEXTRATESG263MI44RUIACT
MAGNESIUM STEARATE70097M6I30IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
ACACIA5C5403N26OIACT
ASPARTAMEZ0H242BBR1IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
MALTODEXTRIN7CVR7L4A2DIACT

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
e221bbce-83e0-0f03-e053-2995a90abca596391d94-678b-41d7-e053-2a95a90adf332022-06-23WarningsExact identifier
spl id: e221bbce-83e0-0f03-e053-2995a90abca5
spl set id: 96391d94-678b-41d7-e053-2a95a90adf33

Reported adverse events (FAERS/openFDA)#

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