BISMUTH SUBSALICYLATE- bismuth subsalicylate capsule, gelatin coated 
Spirit Pharmaceuticals LLC

----------

Stomach Relief Softgels

Drug Facts

Active ingredient ( in each softgel)                        Purpose

Bismuth subsalicylate 262 mg ................Upset stomach reliever and anti-diarrheal

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 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

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

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

beeswax, collidal silicon dioxide, FD&C Red#33, FD&C Yellow#6, gelatin, glycerin, light liquid paraffin, povidone, purified water, soya lecithin, sodium carboxymethyl cellulose, sorbitol sorbitan solution, titanium dioxide

Questions or comments?

1-888-333-9792

PRINCIPAL DISPLAY PANEL

Stomach relief

Bismuth Subsalicylate 262 mg
Upset Stomach Reliever/Antidiarrheal

Soothing relief for 5 symptoms:
• Heartburn • Indigestion • Upset stomach
• Nausea • Diarrhea

12 Softgels

Stomach Relief

BISMUTH SUBSALICYLATE 
bismuth subsalicylate capsule, gelatin coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68210-5018
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)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
POVIDONE (UNII: FZ989GH94E)  
SORBITOL (UNII: 506T60A25R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorpinkScoreno score
ShapeOVAL (Oblong shaped) Size21mm
FlavorImprint Code 262
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68210-5018-11 in 1 CARTON07/19/2023
112 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00807/19/2023
Labeler - Spirit Pharmaceuticals LLC (179621011)

Revised: 12/2023
Document Id: 0c04f115-6b0a-417f-e063-6394a90ac489
Set id: 10143ff8-61f1-4275-89e5-8bd46c662f5a
Version: 3
Effective Time: 20231208
 
Spirit Pharmaceuticals LLC