FDA.reportPublic FDA data

Stomach Relief

Manufacturer
ATLANTIC BIOLOGICALS CORP.
Effective date
2025-05-12
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:00:52

Label at a glance#

ProductStomach Relief Regular Strength
Active ingredientBISMUTH SUBSALICYLATE
Label structure9 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

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)...

Storage and handling

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)

Label contents#

Full prescribing information#

Active ingredient (in each 30 mL dose)

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

  • 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

STORAGE AND HANDLING SECTION

  • 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

INACTIVE INGREDIENT SECTION

benzoic acid, D&C red #22, D&C red #28, flavor, glycerin, purified water, sucralose, xanthan gum

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-645-2158

Distributed by:

ATLANTIC BIOLOGICALS CORP.

20101 N.E 16th PLACE

MIAMI, FL 33179

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to the active ingredient in Pepto-Bismol®*

Regular Strength

Stomach Relief

Bismuth Subsalicylate

Upset Stomach Reliever/Antidiarrheal

Relieves:

• Heartburn • Indigestion • Nausea

Alcohol Free • Sugar Free

image descriptionimage description

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308762bismuth subsalicylate 525 MG in 30 mL Oral SuspensionPSN5
308762bismuth subsalicylate 17.5 MG/ML Oral SuspensionSCD5
308762bismuth subsalicylate 1.75 % Oral SuspensionSY5
308762bismuth subsalicylate 262 MG per 15 ML Oral SuspensionSY5
308762bismuth subsalicylate 524 MG per 30 ML Oral SuspensionSY5
308762bismuth subsalicylate 525 MG per 30 ML Oral SuspensionSY5

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
17856-1286-12024-04-19C16284748780-1d6a99b39-e38a-a426-e053-dadaa90af4c2Drug Facts
17856-1286-22024-04-19C16284748780-1d6a99b39-e38a-a426-e053-dadaa90af4c2Drug Facts
17856-1286-12024-01-30C16284748780-1d6a99b39-e38a-a426-e053-dadaa90af4c2Drug Facts
17856-1286-22024-01-30C16284748780-1d6a99b39-e38a-a426-e053-dadaa90af4c2Drug Facts
17856-1286-12022-05-19C16284748780-1d6a99b39-e38a-a426-e053-dadaa90af4c2Drug Facts
17856-1286-22022-05-19C16284748780-1d6a99b39-e38a-a426-e053-dadaa90af4c2Drug Facts
17856-1286-12022-01-28C16284748780-1d6a99b39-e38a-a426-e053-dadaa90af4c2Drug Facts
17856-1286-22022-01-28C16284748780-1d6a99b39-e38a-a426-e053-dadaa90af4c2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-1286-1Stomach ReliefRegular Strength50 in 1 BOX, UNIT-DOSELIQUID505
17856-1286-2Stomach ReliefRegular Strength50 in 1 BOX, UNIT-DOSELIQUID505
17856-1286-3Stomach ReliefRegular Strength15 mL in 1 CUP, UNIT-DOSELIQUID155
17856-1286-4Stomach ReliefRegular Strength30 mL in 1 CUP, UNIT-DOSELIQUID305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-1286STOMACH RELIEF REGULAR STRENGTH (BISMUTH SUBSALICYLATE) LIQUID [ATLANTIC BIOLOGICALS CORP.]5Current NDC, Legacy NDC, 4 package rows20250514_5c02d0ba-91e4-4bd2-ac66-6905323653b2.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
17856-128617856-1286-3, 17856-1286-1, 17856-1286-4, 17856-1286-2
0536-1286

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZOIC ACID8SKN0B0MIMIACT
D&C RED NO. 221678RKX8RTIACT
D&C RED NO. 28767IP0Y5NHIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
XANTHAN GUMTTV12P4NEEIACT
SUCRALOSE96K6UQ3ZD4IACT
BISMUTH SUBSALICYLATE62TEY51RR1ACTIB

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stomach Relief Regular StrengthBISMUTH SUBSALICYLATERugby Laboratories6166c04e-20c6-4678-b16d-5174744456982026-06-26WarningsExact identifier
ndc (product): 0536-1286
Stomach Relief Regular StrengthBISMUTH SUBSALICYLATEATLANTIC BIOLOGICALS CORP.5c02d0ba-91e4-4bd2-ac66-6905323653b22025-05-12WarningsExact identifier
ndc (package): 17856-1286-4
ndc (package): 17856-1286-1
ndc (package): 17856-1286-2
ndc (package): 17856-1286-3
ndc (product): 17856-1286
ndc11 (package): 17856128602
ndc11 (package): 17856128601
ndc11 (package): 17856128603
ndc11 (package): 17856128604
spl id: 34f36bfa-3ffc-825c-e063-6394a90a45b9
spl set id: 5c02d0ba-91e4-4bd2-ac66-6905323653b2

Reported adverse events (FAERS/openFDA)#

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