STOMACH RELIEF- bismuth subsalicylate liquid

Stomach Relief by

Drug Labeling and Warnings

Stomach Relief 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 30 mL)

Bismuth subsalicylate 525 mg

Purpose

Upset stomach reliever/Antidiarrheal

Uses

relieves

• diarrhea
• travelers' diarrhea  
• upset stomach due to overindulgence in food and drink, including:
  • heartburn
  • indigestion
  • nausea
  • gas
  • fullness
  • belching

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

• diabetes
• gout
• arthritis
• anticoagulation (thinning the blood)

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 childen.

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

Directions

• mL = milliliter
• shake well before using
• measure only with dosing cup provided. Do not use any other dosing device
• keep dosing cup with product
• adult and children 12 years and over:
  • 30 mL (1 dose) every 1/2 or 60 mL (2 doses) every hour as needed for diarrhea/traveler's diarrhea
  • 30 mL (1 dose) every 1/2 hour as needed for overindulgence (unset stomach, heartburn, indigestion, nausea)
  • do not exceed 8 doses (240 mL) in 24 hour
  • use until diarrhea stop but not more than 2 days
• children under 12 years of age: ask a doctor
• drink plenty of clear fluids to help prevent dehydration cause by diarrhea

Other information

• each 30 mL  contains: sodium 11 mg
• each 30 mL  contains: salicylate 206 mg
• low sodium 
• keep tightly closed
• protect from freezing
• avoid excessive heat (over 104ºF or 40ºC)

Inactive ingredients

benzoic acid, D&C red #22, D&C red #28, flavor, glycerin,purified water, sucralose, xanthan gum

Questions or comments?

Call 1-800-935-2362 Monday-Friday 9AM-5PM EST

Principal Display Panel

*Compare to the Active Ingredient in  Pepto-Bismal®

Regular Strength

Stomach Relief

Stomach Relief

Bismuth Subsalicylate | Stomach Reliever,

Antidiarrheal

For Relief of:

heartburn

Indigestion

Nausea

Upset Stomach

Diarrhea

Alcohol Free

Sugar Free

Cherry Flavor

FL OZ (mL)

*This product is not manufactured or distributed by Procter & Gamble Company. Pepto-Bismol® is a registered trademark of th Procter & Gamble Company  

TAMPER EVIDENT; DO NOT USE IF PRINTED SAFETY SEAL AROUND DOSAGE CUP OR UNDER CAP IS BROKEN OR MISSING.

Distributed by C.D.M.A., Inc©

43157 W 9 Mile Rd

Novi, MI 48375

www.qualitychoice.com

Package Label

QUALITY CHOICE Stomach Relief

INGREDIENTS AND APPEARANCE

STOMACH RELIEF 
bismuth subsalicylate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63868-832
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 30 mL

Inactive Ingredients
Ingredient Name	Strength
BENZOIC ACID (UNII: 8SKN0B0MIM)
D&C RED NO. 22 (UNII: 1678RKX8RT)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63868-832-08	237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/26/2021	03/26/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M008	03/26/2021	03/26/2026

Labeler - QUALITY CHOICE (Chain Drug Marketing Association) (011920774)