BISMUTH CHEWABLE- bismuth subsalicylate 262 mg tablet, chewable 
Marc Glassman, Inc.

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046 - Bismuth

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

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) 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

Bismuth

 

BISMUTH CHEWABLE 
bismuth subsalicylate 262 mg tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68998-046
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ) BISMUTH SUBSALICYLATE262 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorpinkScoreno score
ShapeROUNDSize17mm
FlavorPEPPERMINTImprint Code RH;046
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68998-046-8830 in 1 CARTON04/28/2003
11 in 1 CELLO PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00804/28/2003
Labeler - Marc Glassman, Inc. (094487477)

Revised: 12/2016
Document Id: 81a0328d-4a00-4331-b9c3-aaedaf455e51
Set id: cdfcfdc2-ed5e-49d8-b16f-e32748d82e3e
Version: 7
Effective Time: 20161219
 
Marc Glassman, Inc.