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NDC 63868-0907-08 Stomach Relief 525 mg/30mL Details

Stomach Relief 525 mg/30mL

Stomach Relief is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by QUALITY CHOICE (Chain Drug Marketing Association). The primary component is BISMUTH SUBSALICYLATE.

MedlinePlus Drug Summary

Bismuth subsalicylate is used to treat diarrhea, heartburn, and upset stomach in adults and children 12 years of age and older. Bismuth subsalicylate is in a class of medications called antidiarrheal agents. It works by decreasing the flow of fluids and electrolytes into the bowel, reduces inflammation within the intestine, and may kill the organisms that can cause diarrhea.

Related Packages: 63868-0907-08
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Bismuth Subsalicylate

Product Information

NDC	63868-0907
Product ID	63868-907_8ddf9643-2ef3-449b-b110-5fa060847080
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Stomach Relief
Proprietary Name Suffix	Regular Strength
Non-Proprietary Name	Bismuth subsalicylate
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	ORAL
Active Ingredient Strength	525
Active Ingredient Units	mg/30mL
Substance Name	BISMUTH SUBSALICYLATE
Labeler Name	QUALITY CHOICE (Chain Drug Marketing Association)
Pharmaceutical Class	Bismuth [CS], Bismuth [EPC]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part335
Listing Certified Through	2024-12-31

Package

Package Images

NDC 63868-0907-08 (63868090708)

Pricing Information	N/A
NDC Package Code	63868-907-08
Billing NDC	63868090708
Package	237 mL in 1 BOTTLE, PLASTIC (63868-907-08)
Marketing Start Date	2022-01-28
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 638ab578-5883-4569-8e14-ed977e5db877 Details

Active ingredient (in each 30 mL dose)

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
adults 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 (upset stomach, heartburn, indigestion, nausea)
- do not exceed 8 doses (240 mL) in 24 hours
- use until diarrhea stops but not more than 2 days
children under 12 years of age: ask a doctor
drink plenty of clear fluids to help prevent dehydration caused by diarrhea

Other information

each 30 mL contains: potassium 8 mg sodium 9 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 on Pepto Bismol®

Regular Strength

Stomach Relief

Bismuth Subsalicylate | Upset Stomach Reliever,

Antidiarrheal

For Relief of :

Heartburn

Indigestion

Nausea

Upset Stomach

Diarrhea

Alcohol Free

Sugar Free

FL OZ (mL)

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

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

43157 W 9 Mile Rd

Novi, MI 48375

www.qualitychoice.com

Package Label

QUALITY CHOICE Regular Strength Stomach Relief

INGREDIENTS AND APPEARANCE

STOMACH RELIEF REGULAR STRENGTH

bismuth subsalicylate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63868-907
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (BISMUTH CATION - UNII:ZS9CD1I8YE, SALICYLIC ACID - UNII:O414PZ4LPZ)	BISMUTH SUBSALICYLATE	525 mg in 30 mL

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63868-907-08	237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/28/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part335	01/28/2022

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

Revised: 6/2022

Document Id: 8ddf9643-2ef3-449b-b110-5fa060847080

Set id: 638ab578-5883-4569-8e14-ed977e5db877

Version: 1

Effective Time: 20220624