FDA.reportPublic FDA data

Stomach Relief

Manufacturer
P & L Development, LLC
Effective date
2024-04-16
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:11:11

Label at a glance#

ProductStomach Relief Ultra Strength
Active ingredientBISMUTH SUBSALICYLATE
Label structure10 sections

Indications and uses

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

Dosage and administration

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 (1 dose) every 1/2 hour or 30 mL (2 doses) every hou...

Storage and handling

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)

Label contents#

Full prescribing information#

Active ingredient (in each 15 mL )

OTC - ACTIVE INGREDIENT SECTION

Bismuth subsalicylate 525 mg

Purpose

OTC - PURPOSE SECTION

Upset stomach reliever/Antidiarrheal

Uses

INDICATIONS & USAGE SECTION

relieves

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

Warnings

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

if you have

  • an ulcer
  • a bleeding problem
  • bloody or black stool

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • fever
  • mucus in the stool

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking any drug for

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

When using this product

OTC - WHEN USING SECTION

a temporary, but harmless, darkening of the stool and/or tongue may occur.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of childen.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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 (1 dose) every 1/2 hour or 30 mL (2 doses) every hour as needed for diarrhea/traveler's diarrhea
    • 15 mL (1 dose) every 1/2 as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
  • children under 12 years of age: ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • 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

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

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

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to the active ingredient in Pepto-Bismol® Ultra*

Ultra Stomach Relief

Bismuth subsalicylate 525 mg

upset stomach reliever/antidiarrheal

Relieves:

  • heartburn
  • indigestion
  • nausea
  • upset stomach
  • diarrhea

2x strength per ounce†

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.

Manufactured by:

PL Developments

11865 S. Alameda St

Lynwood, CA 90262

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

READYinCASE Stomach Relief Ultra
READYinCASE Stomach Relief Ultra

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308763bismuth subsalicylate 1050 MG in 30 mL Oral SuspensionPSN3
308763bismuth subsalicylate 35 MG/ML Oral SuspensionSCD3
308763bismuth subsalicylate 1050 MG per 30 ML Oral SuspensionSY3
308763bismuth subsalicylate 525 MG per 15 ML Oral SuspensionSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BISMUTH CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0be8e4ae-4d57-49f3-b3a9-e4728b4e8d15Product name120240313
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49580-0842-82023-06-01C16284748780-1f386c649-e414-0266-e053-dadaa90a7c1aDrug Facts
49580-0842-82023-01-30C16284748780-1f386c649-e414-0266-e053-dadaa90a7c1aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49580-0842-8Stomach ReliefUltra Strength237 mL in 1 BOTTLE, PLASTICLIQUID2373

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49580-0842STOMACH RELIEF ULTRA STRENGTH (BISMUTH SUBSALICYLATE) LIQUID [P & L DEVELOPMENT, LLC]3Current NDC, Legacy NDC, 1 package rows20240418_cb5ca7ab-39cf-4b07-ac22-a00b214db102.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49580-084249580-0842-8

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
BISMUTH SUBSALICYLATE62TEY51RR1ACTIB
BENZOIC ACID8SKN0B0MIMIACT
D&C RED NO. 221678RKX8RTIACT
D&C RED NO. 28767IP0Y5NHIACT
MAGNESIUM ALUMINUM SILICATE6M3P64V0NCIACT
WATER059QF0KO0RIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SALICYLIC ACIDO414PZ4LPZIACT
SODIUM SALICYLATEWIQ1H85SYPIACT
SORBIC ACIDX045WJ989BIACT
METHYLCELLULOSE (1500 CPS)P0NTE48364IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stomach Relief Ultra StrengthBISMUTH SUBSALICYLATEP & L Development, LLCcb5ca7ab-39cf-4b07-ac22-a00b214db1022024-04-16WarningsExact identifier
ndc (package): 49580-0842-8
ndc (product): 49580-0842
ndc11 (package): 49580084208
spl id: 2098abda-1027-4fc4-b273-2a0f39316a41
spl set id: cb5ca7ab-39cf-4b07-ac22-a00b214db102

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.