Search by Drug Name or NDC

NDC 46122-0595-34 Stomach Relief 525 mg/15mL Details

Stomach Relief 525 mg/15mL

Stomach Relief is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by AmerisourceBergen (Good Neighbor Pharmacy) 46122. 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: 46122-0595-34
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Bismuth Subsalicylate

Product Information

NDC	46122-0595
Product ID	46122-595_7b1e8d32-5301-4f00-a710-366fd91bb8d4
Associated GPIs
GCN Sequence Number	002859
GCN Sequence Number Description	bismuth subsalicylate ORAL SUSP 525MG/15ML ORAL
HIC3	D6D
HIC3 Description	ANTIDIARRHEALS
GCN	26971
HICL Sequence Number	001246
HICL Sequence Number Description	BISMUTH SUBSALICYLATE
Brand/Generic	Generic
Proprietary Name	Stomach Relief
Proprietary Name Suffix	Ultra
Non-Proprietary Name	Bismuth subsalicylate
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	ORAL
Active Ingredient Strength	525
Active Ingredient Units	mg/15mL
Substance Name	BISMUTH SUBSALICYLATE
Labeler Name	AmerisourceBergen (Good Neighbor Pharmacy) 46122
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 46122-0595-34 (46122059534)

Pricing Information	N/A
NDC Package Code	46122-595-34
Billing NDC	46122059534
Package	237 mL in 1 BOTTLE, PLASTIC (46122-595-34)
Marketing Start Date	2019-03-31
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 7e046e8e-f38e-4897-b70b-6d8f75287f46 Details

Active ingredient (in each 15 mL)

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
- 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

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

do not take more than 8 doses (120 mL) in 24 hours
use until diarrhea stops but not more than 2 days
drink plenty of clear fluids to help prevent dehydration caused by diarrhea
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:
- 15 mL (1dose) every 1/2 or 30 mL (2 doses) every hour as needed diarrhea/traveler's diarrhea
- 15 mL (1 dose) every 1/2 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
children under 12 years of age: ask a doctor

Other information

each 15 mL contains: sodium 6 mg
each 15 mL contains: salicylate 227 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, magnesium aluminum silicate, methylcellulose, purified water, saccharin sodium, salicylic acid, sodium salicylate, sorbic acid

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to Ultra Pepto-Bismol® active ingredient*

ULTRA

Stomach Relief

2x Strength Per Ounce†

Upset Stomach Reliever/Antidiarrheal

(Bismuth Subsalicylate 525 mg)

Soothing Relief For 5 Symptoms:

Upset Stomach
Indigestion
Heartburn
Diarrhea
Nausea

Alcohol Free

Sugar Free

†vs. Original Pepto-Bismol®

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.

Distributed by AmerisouceBergen

1300 Morris Drive, Chesterbrook,, PA 19087

www.mygnp.com

Package Label

GOOD NEIGHBOR PHARMACY Ultra Stomach Relief

INGREDIENTS AND APPEARANCE

STOMACH RELIEF ULTRA

bismuth subsalicylate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:46122-595
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 15 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:46122-595-34	237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/31/2019	01/03/2025

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part335	03/31/2019	01/03/2025

Labeler - AmerisourceBergen (Good Neighbor Pharmacy) 46122 (007914906)

Revised: 10/2021

Document Id: 7b1e8d32-5301-4f00-a710-366fd91bb8d4

Set id: 7e046e8e-f38e-4897-b70b-6d8f75287f46

Version: 2

Effective Time: 20211015