UPSET STOMACH RELIEF-BISMUTH SUBSALICYLATE 262 MG- bismuth subsalicylate 262 mg capsule, liquid filled

Upset Stomach Relief-Bismuth Subsalicylate 262 mg by

Drug Labeling and Warnings

Upset Stomach Relief-Bismuth Subsalicylate 262 mg by is a Otc medication manufactured, distributed, or labeled by Pioneer Life Sciences, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient (in each softgel)

Bismuth subsalicylate 262 mg

Purpose

Upset stomach reliever and antidiarrheal

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

Do not use if you have ■ an ulcer ■ a bleeding problem ■ bloody or black stool

ASK DOCTOR

Ask a doctor before use if you have ■ fever ■ mucus in the stool

ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are taking any drug for ■ anticoagulation (thinning the blood) ■ diabetes ■ gout ■ arthritis

WHEN USING

When using this product a temporary, but harmless, darkening of the stool and/or tongue may occur

STOP USE

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

PREGNANCY OR BREAST FEEDING

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 overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

■ swallow with water, do not chew
■ adults and children 12 years and over:
■ 2 softgels every ½ hour or 4 softgels every hour as needed for diarrhea
■ 2 softgels every ½ hour to 1 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
■ low sodium
■ do not exceed 25°C

Inactive ingredients

Polyethylene Glycol-400, Polysorbate 80, Soya Lecithin, Povidone (PVPK 30), Gelatin, Glycerin, Sorbitol Sorbitan Solution, D & C Red 33 , Titanium Dioxide, Purified Water

Questions or Comments?

Call +1 (732) 994-2808 or email support@gencare.health

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

UPSET STOMACH RELIEF-BISMUTH SUBSALICYLATE 262 MG 
bismuth subsalicylate 262 mg capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72090-053
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
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SOYBEAN LECITHIN (UNII: 1DI56QDM62)
POVIDONE K30 (UNII: U725QWY32X)
Gelatin (UNII: 2G86QN327L)
Glycerin (UNII: PDC6A3C0OX)
SORBITOL SOLUTION (UNII: 8KW3E207O2)
SORBITAN (UNII: 6O92ICV9RU)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
Titanium Dioxide (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	pink (Opaque baby pink)	Score	no score
Shape	OVAL (Oblong)	Size	20mm
Flavor		Imprint Code	SD30
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72090-053-01	48 in 1 BOTTLE; Type 0: Not a Combination Product	06/27/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M008	06/27/2025

Labeler - Pioneer Life Sciences, LLC (014092742)