CRANE SAFETY BISMUTH- bismuth subsalicylate tablet, chewable

Crane Safety Bismuth by

Drug Labeling and Warnings

Crane Safety Bismuth by is a Otc medication manufactured, distributed, or labeled by Crane Safety LLC, Unifirst First Aid Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (in each tablet)

Bismuth Subsalicylate 262 mg

(each tablet contains 102 mg salicylate)

Purpose

Upset stomach reliever/antidiarrheal

Uses

Temporarily relieves

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

Warnings

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

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

Ask a doctor before use if you have

• fever
• mucus in the stool

Ask a doctor or pharmacist if you are taking any drug for

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

Stop use and ask a doctor if

• symptoms get worse
• ringing in the ears or loss of hearing occurs
• diarrhea lasts more than 2 days

When using this product

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,

ask a health professional before use.

Keep this and all drugs out of reach of children.

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

Directions

• 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

• 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

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

Questions or comments?

877.506.4291

Crane Safety Bismuth Label

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

INGREDIENTS AND APPEARANCE

CRANE SAFETY BISMUTH 
bismuth subsalicylate tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73408-406(NDC:47682-406)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ)	BISMUTH SUBSALICYLATE	262 mg

Inactive Ingredients
Ingredient Name	Strength
D&C RED NO. 27 (UNII: 2LRS185U6K)
CALCIUM CARBONATE (UNII: H0G9379FGK)
DEXTRATES (UNII: G263MI44RU)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ACACIA (UNII: 5C5403N26O)
ASPARTAME (UNII: Z0H242BBR1)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
MALTODEXTRIN (UNII: 7CVR7L4A2D)

Product Characteristics
Color	pink	Score	no score
Shape	ROUND	Size	16mm
Flavor		Imprint Code	RH;046
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73408-406-20	6 in 1 BOX	01/17/2020
1		6 in 1 CELLO PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part335	01/17/2020

Labeler - Crane Safety LLC (080998015)

Registrant - Unifirst First Aid Corporation (832947092)

Establishment
Name	Address	ID/FEI	Business Operations
Medique Products		086911794	relabel(73408-406) , repack(73408-406)