BISMUTH CHEWABLE- bismuth subsalicylate 262 mg tablet, chewable

Bismuth Chewable by

Drug Labeling and Warnings

Bismuth Chewable by is a Otc medication manufactured, distributed, or labeled by Marc Glassman, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

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

Purpose

Antidiarrheal/Antacid

Uses

■ controls diarrhea   

■ relieves heartburn, indigestion, nausea and upset stomach

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 before use if

you are taking a drug for  

■ anticoagulation (thinning of the blood)   

■ diabetes   

■ gout   

■ arthritis

When using this product

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

Stop use and ask a doctor if

■ symptoms get worse  

■ ringing in the ears or loss of hearing occurs  

■ diarrhea lasts for more than 2 days

Pregnancy/Breastfeeding

If pregnant or breast feeding, ask a health professional before use.

Keep out of reach of children

Keep out of reach of children. In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) immediately.

Directions

■ 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

■ 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

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

Principal Display Panel

Bismuth

 

INGREDIENTS AND APPEARANCE

BISMUTH CHEWABLE 
bismuth subsalicylate 262 mg tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68998-046
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
ASPARTAME (UNII: Z0H242BBR1)
CALCIUM CARBONATE (UNII: H0G9379FGK)
D&C RED NO. 27 (UNII: 2LRS185U6K)
DEXTRATES (UNII: G263MI44RU)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	PINK	Score	no score
Shape	ROUND	Size	17mm
Flavor	PEPPERMINT	Imprint Code	RH;046
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68998-046-88	30 in 1 CARTON	04/28/2003
1		1 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	04/28/2003

Labeler - Marc Glassman, Inc. (094487477)