BISMUTH- bismuth subsalicylate tablet

Bismuth by

Drug Labeling and Warnings

Bismuth by is a Otc medication manufactured, distributed, or labeled by Allegiant Health. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

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

Purpose

Antidiarrheal/Antacid

Uses

• relieves
• travelers’ 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

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

Ask a doctor before use if you have

• fever
• mucus in the stool

Ask a doctor or pharmacist before use if you

are taking any drug for

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

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  n diarrhea lasts more than 2 days

When using this product

a temporary, but harmless, darkening of the stool and/or tongue may occur

If pregnant or breast-feeding

ask a health professional before use.

Keep Out of Reach of Children

In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) right away. 

Directions

• chew or dissolve in mouth
• Adults and children over 12 years : 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
• drink plenty of clear fluids to prevent dehydration caused by diarrhea 

Inactive Ingredients

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

Package/Label Principal Display Panel

Bismuth subsalicylate 262mg

INGREDIENTS AND APPEARANCE

BISMUTH 
bismuth subsalicylate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69168-046
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (BISMUTH CATION - UNII:ZS9CD1I8YE)	BISMUTH SUBSALICYLATE	262 mg

Inactive Ingredients
Ingredient Name	Strength
ASPARTAME (UNII: Z0H242BBR1)
CALCIUM CARBONATE (UNII: H0G9379FGK)
D&C RED NO. 27 (UNII: 2LRS185U6K)
DEXTRATES (UNII: G263MI44RU)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ACACIA (UNII: 5C5403N26O)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
PEPPERMINT (UNII: V95R5KMY2B)

Product Characteristics
Color	PINK	Score	no score
Shape	ROUND	Size	17mm
Flavor		Imprint Code	RH046
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69168-046-69	12 in 1 CELLO PACK; Type 0: Not a Combination Product	12/23/2014
2	NDC: 69168-046-88	30 in 1 CELLO PACK; Type 0: Not a Combination Product	12/23/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part335	12/23/2014

Labeler - Allegiant Health (079501930)