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NDC 70000-0045-01 Stomach Relief Ultra 525 mg/15mL Details

Stomach Relief Ultra 525 mg/15mL

Stomach Relief Ultra is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Cardinal Health (Leader) 70000. 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: 70000-0045-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Bismuth Subsalicylate

Product Information

NDC	70000-0045
Product ID	70000-0045_db5d6bf5-885d-40b4-ba34-6d108c313ac0
Associated GPIs	47300010001830
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 Ultra
Proprietary Name Suffix	n/a
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	Cardinal Health (Leader) 70000
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 70000-0045-01 (70000004501)

Pricing Information
NDC Package Code	70000-0045-1
Billing NDC	70000004501
Package	355 mL in 1 BOTTLE, PLASTIC (70000-0045-1)
Marketing Start Date	2020-02-25
NDC Exclude Flag	N
Price Per Unit	0.00845
Pricing Unit	ML
Effective Date	2023-03-22
NDC Description	STOMACH RELIEF 525 MG/15 ML
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	4, 5
Classification for Rate Setting	G
As of Date	2024-02-21

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL 5f7a0905-344b-40e1-8b32-171dabb560b3 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 5 mg
each 15 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 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

COMPARE TO PEPTO-BISMOL® ULTRA active ingredient*

Ultra

Stomach Relief

Bismuth Subsalicylate 525 mg per 15 mL

Upset Stomach Reliever / Antidiarrheal

Relieves

Heartburn, Indigestion, Nausea, Upset Stomach, Diarrhea

2x Strength per Ounce†

Alcohol Free

Sugar Free

FL OZ (mL)

†vs Original Pepto-Bismol®

*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 CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com

Package Label

LEADER Ultra Stomach Relief

INGREDIENTS AND APPEARANCE

STOMACH RELIEF ULTRA

bismuth subsalicylate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70000-0045
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)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70000-0045-1	355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/25/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part335	02/25/2020

Labeler - Cardinal Health (Leader) 70000 (063997360)

Revised: 11/2022

Document Id: db5d6bf5-885d-40b4-ba34-6d108c313ac0

Set id: 5f7a0905-344b-40e1-8b32-171dabb560b3

Version: 3

Effective Time: 20221111