STOMACH RELIEF- bismuth subsalicylate capsule, liquid filled 
Spirit Pharmaceuticals LLC

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Stomach Relief

Drug Facts

Active Ingredient (in each tablet)

Bismuth subsalicylate 262 mg

Purpose

Upset stomach reliever and anti-diarrheal

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 if you are

you are taking any drug for • anticoagulation (thinning the blood) • diabetes • gout • arthritis

When using this product

• 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. (1-800-222-1222)

Directions

• swallow with water, do not chew • adults and children 12 years and over: • 2 softgels (1 dose) every 1/2 hour or 4 softgels (2 doses) every hour as needed for diarrhea • 2 soft gels (1 dose) every 1/2 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea) • do not exceed 8 doses (16 softgels) in 24 hours • use until diarrhea stops but not more than 2 days • children under 12 years: ask a doctor • drink plenty of clear fluids to help prevent dehydration caused by diarrhea

Other information

• each softgel contains: Salicylate 99 mg • very low sodium • store between 15–30°C (59–86°F)

Inactive ingredients

Aerosil, beeswax, FD&C Red No. 33, FD&C Yellow No. 6, gelatin, glycerin, light liquid paraffin, purified water, soya lecithin, sodium carboxy methyl cellulose, sorbitol solution, titanium dioxide

Questions or comments?

1-888-333-9792

Pouch

Stomach Relief

STOMACH RELIEF 
bismuth subsalicylate capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68210-4170
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
SYNTHETIC BEESWAX (UNII: 08MNR5YE2R)  
SILICON (UNII: Z4152N8IUI)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
PARAFFIN (UNII: I9O0E3H2ZE)  
WATER (UNII: 059QF0KO0R)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
HYDROXYMETHYL CELLULOSE (UNII: 273FM27VK1)  
SORBITOL SOLUTION (UNII: 8KW3E207O2)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorpinkScoreno score
ShapeCAPSULESize14mm
FlavorImprint Code 262
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68210-4170-110 in 1 POUCH; Type 0: Not a Combination Product11/22/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00811/22/2021
Labeler - Spirit Pharmaceuticals LLC (179621011)

Revised: 12/2023
Document Id: 0befda4d-7104-1da8-e063-6394a90a1600
Set id: 37cb2581-3f94-4085-ac77-76b8f77a2486
Version: 4
Effective Time: 20231207
 
Spirit Pharmaceuticals LLC