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NDC 30142-0371-12 Stomach Relief 1050 mg/30mL Details

Stomach Relief 1050 mg/30mL

Stomach Relief is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by The Kroger Co.. 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: 30142-0371-12
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Bismuth Subsalicylate

Product Information

NDC	30142-0371
Product ID	30142-371_ca95dc3f-135d-420b-a68b-b834ba3b691e
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	Maximum Strength
Non-Proprietary Name	Bismuth subsalicylate
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	ORAL
Active Ingredient Strength	1050
Active Ingredient Units	mg/30mL
Substance Name	BISMUTH SUBSALICYLATE
Labeler Name	The Kroger Co.
Pharmaceutical Class	Bismuth [CS], Bismuth [EPC]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part335
Listing Certified Through	n/a

Package

Package Images

NDC 30142-0371-12 (30142037112)

Pricing Information	N/A
NDC Package Code	30142-371-12
Billing NDC	30142037112
Package	354 mL in 1 BOTTLE, PLASTIC (30142-371-12)
Marketing Start Date	2016-03-31
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 9f2b858e-9515-4816-ac80-155316a26c7a Details

Active ingredient (in each 30 mL)

Bismuth subsalicylate 1050 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
- fullness
- belching

Warnings

Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms ahould 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

a sodium-restricted diet
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) righy 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 hour as needed
- do not take more than 4 doses (120 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: sodium 19 mg
each 30 mL contains: salicylate 455 mg
sugar free
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, magnesium aluminum silicate, methylcellulose, purified water, saccharin sodium, salicylic acid, sodium salicylate, sorbic acid

Questions or comments?

Call 1-800-632-6900

Principal Display Panel

Compare To the active ingredient of PEPTO-BISMOL® *See side panel

MAXIMUM STRENGTH

Stomach Relief

UPSET STOMACH RELIEVER / ANTIDIARRHEAL

Bismuth subsalicylate 1050 mg

Protective Coating Action

Soothing Relief for 5 Symptoms:

Heartburn
Indigestion
Upset Stomach
Nausea
Diarrhea

FL OZ (mL)

GLUTEN FREE

*PEPTO-BISMOL® IS A REGISTERED TRADEMARK OF PROCTER & GAMBLE, CINCINNATI, OH 45202. PROCTER & GAMBLE IS NOT AFFILIATED WITH THE KROGER CO. OR THIS PRODUCT.

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

DISTRIBUTED BY THE KROGER CO.

CINCINNATI, OHIO 45202

www.kroger.com

Package Label

Kroger Maximum Strength Stomach Relief

INGREDIENTS AND APPEARANCE

STOMACH RELIEF MAXIMUM STRENGTH

bismuth subsalicylate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:30142-371
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	1050 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)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SALICYLIC ACID (UNII: O414PZ4LPZ)
SODIUM SALICYLATE (UNII: WIQ1H85SYP)
SORBIC ACID (UNII: X045WJ989B)
METHYLCELLULOSE (1500 CPS) (UNII: P0NTE48364)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:30142-371-12	354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/31/2016	02/23/2024

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part335	03/31/2016	02/23/2024

Labeler - The Kroger Co. (006999528)

Revised: 11/2021

Document Id: ca95dc3f-135d-420b-a68b-b834ba3b691e

Set id: 9f2b858e-9515-4816-ac80-155316a26c7a

Version: 3

Effective Time: 20211108