BISMUTH SUBSALICYLATE- bismuth subsalicylate capsule, liquid filled 
Softgel Healthcare Pvt Ltd

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Bismuth Subsalicylate Capsules 262 mg

Active ingredient (in each softgel)

Bismuth subsalicylate 262 mg

Purpose

Upset stomach reliever and antidiarrheal

Uses

relieves

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 Reye’s syndrome, a rare but serious illness.

Allergy alert:

Contains salicylate. Do not take if you are

Do not use if

you have

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

taking any drug for

When using this product

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

Stop use and ask a doctor if

If pregnant or breast feeding,

ask a health professional before use

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive ingredients

Carton

BISMUTH SUBSALICYLATE 
bismuth subsalicylate capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35916-0234
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
WATER (UNII: 059QF0KO0R)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
GELATIN (UNII: 2G86QN327L)  
POVIDONE (UNII: FZ989GH94E)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
Colorpink (Opaque) Scoreno score
ShapeCAPSULE (oblong) Size21mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:35916-0234-11 in 1 CARTON05/27/2024
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00805/27/2024
Labeler - Softgel Healthcare Pvt Ltd (675584180)

Revised: 5/2024
Document Id: 18f59606-1499-bd0c-e063-6394a90a7df2
Set id: 18f59606-1498-bd0c-e063-6394a90a7df2
Version: 1
Effective Time: 20240527
 
Softgel Healthcare Pvt Ltd