QUALITY CHOICE ULTRA STRENGTH STOMACH RELIEF- bismuth subsalicylate liquid

QUALITY CHOICE by

Drug Labeling and Warnings

QUALITY CHOICE by is a Otc medication manufactured, distributed, or labeled by QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each 15 mL dose)

Bismuth subsalicylate 525 mg

Purpose

Upset stomach reliever/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

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 at 1-800-222-1222.

Directions

• shake well before use
• Only use dose cup provided
• adults and children 12 years and over
  • 15 mL (1 dose) every ½ hour or 30 mL (2 doses) every hour as needed for diarrhea/traveler’s diarrhea.
  • 15 mL (1 dose) every ½ hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
  • do not exceed 8 doses (120 mL) 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 15 mL dose cup contains:potassium 7 mg, sodium 5 mg
• salicylate 230 mg
• low sodium
• sugar free
• protect from freezing
• avoid excessive heat (more than 104ºF or 40ºC)
• TAMPER EVIDENT: Do not use if imprinted shrink band is missing or broken

Inactive ingredients

Carboxymethylcellulose sodium, D&C Red No. 22, D&C Red No. 28, flavor, gellan gum, microcrystalline cellulose, potassium hydroxide, potassium sorbate, purified water, salicylic acid, simethicone emulsion, sodium benzoate, sucralose, xanthan gum.

Principal Display Panel

*Compare to the active ingredient in Pepto-Bismol® Ultra Strength

QUALITY CHOICE

Ultra Strength

Stomach Relief

Bismuth Subsalicylate 525 mg

Upset Stomach Reliever/ Antidiarrheal

Relieves:

Nausea, Heartburn, Indigestion, Upset Stomach & Diarrhea

2X CONCENTRATED FORMULA**

Original Flavor

8 FL OZ (236 mL)

100% QC SATISFACTION GURANTEED

*This product is not manufactured or distributed by The Procter & Gamble, distributors of Pepto-Bismol ®Ultra Strength.

Distributed by CDMA, Inc.

Novi, MI 48375

www.qualitychoice.com

Questions: 800-935-2362

INGREDIENTS AND APPEARANCE

QUALITY CHOICE   ULTRA STRENGTH STOMACH RELIEF
bismuth subsalicylate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83324-337
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (BISMUTH CATION - UNII:ZS9CD1I8YE, SALICYLIC ACID - UNII:O414PZ4LPZ)	BISMUTH SUBSALICYLATE	525 mg  in 15 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
D&C RED NO. 22 (UNII: 1678RKX8RT)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
GELLAN GUM (HIGH ACYL) (UNII: W1L7G7ROMD)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
WATER (UNII: 059QF0KO0R)
SALICYLIC ACID (UNII: O414PZ4LPZ)
DIMETHICONE, UNSPECIFIED (UNII: 92RU3N3Y1O)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	pink (viscous)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83324-337-08	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/07/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M008	07/07/2025

Labeler - QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION) (011920774)