Ultra Strength Stomach Relief

Manufacturer
Retail Business Services, LLC. | Guardian Drug Company
Effective date
2025-07-21
Label type
Human OTC Drug Label
Version
2
Source
full-release
Hydrated at
2026-06-01 01:08:05

Label at a glance#

ProductUltra Strength Stomach Relief
Active ingredientBISMUTH SUBSALICYLATE
Label structure15 sections

Dosage and administration

shake well before use mL = milliliter TBSP = tablespoon adults and children 12 years and over: 1 dose (1 TBSP or 15 mL) every 1/2 hour as needed do not exceed 8 doses (120 mL) in 24 hours use until diarrhea stops but not more than 2 days children under 12 years: ask a doctor drink plenty of fluids to help prevent dehydration caused by diarrhea

Storage and handling

each 15 mL or 1 TBSP contains: potassium 15 mg salicylate 236 mg sodium 5 mg protect from freezing avoid excessive heat (over 104 o F or 40 o C) dosage cup provided

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 and anti-diarrheal

USE(S)

INDICATIONS & USAGE SECTION

relieves:


  • diarrhea
  • heartburn
  • indigestion
  • nausea
  • upset stomach associated with these symptoms

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 IF YOU HAVE

OTC - DO NOT USE SECTION

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

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 


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

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 DOCTOR IF

OTC - STOP USE SECTION

  • symptoms get worse
  • 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 CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center immediately.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • shake well before use
  • mL = milliliter
  • TBSP = tablespoon
  • adults and children 12 years and over: 1 dose (1 TBSP or 15 mL) every 1/2 hour as needed
  • do not exceed 8 doses (120 mL) in 24 hours
  • use until diarrhea stops but not more than 2 days
  • children under 12 years: ask a doctor
  • drink plenty of fluids to help prevent dehydration caused by diarrhea

OTHER INFORMATION

STORAGE AND HANDLING SECTION

  • each 15 mL or 1 TBSP contains:
  • potassium 15 mg
  • salicylate 236 mg
  • sodium 5 mg
  • protect from freezing
  • avoid excessive heat (over 104oF or 40oC)
  • dosage cup provided

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

benzoic acid, D&C red # 22, D&C red # 28, flavor, hydroxyethyl cellulose, potassium hydroxide, purified water, saccharin sodium, salicylic acid, simethicone, xanthan gum

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CAREOne

 

NDC 72476-528-04

Compare to the active ingredient in Pepto-Bismol@ Ultra Strength*


Bismuth Subsalicylate 525 mg

Upset stomach reliever/Antidiarrheal


Original Flavor

SOOTHING RELIEF FOR:

Upset stomach, Indigestion,

Nausea, Heartburn, Diarrhea


PROTECTIVE COATING



8 FL OZ (236 mL)  

3-528-8-care-o.jpg
3-528-8-care-o.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308763bismuth subsalicylate 1050 MG in 30 mL Oral SuspensionPSN2
308763bismuth subsalicylate 35 MG/ML Oral SuspensionSCD2
308763bismuth subsalicylate 1050 MG per 30 ML Oral SuspensionSY2
308763bismuth subsalicylate 525 MG per 15 ML Oral SuspensionSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72476-528-04Ultra Strength Stomach Relief236 mL in 1 BOTTLELIQUID2362

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
72476-52872476-528-04

Ingredients#

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

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

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
Ultra Strength Stomach ReliefBISMUTH SUBSALICYLATE 525 MGRetail Business Services, LLC.338ca589-91ff-30ed-e063-6294a90a243a2025-07-21WarningsExact identifier
ndc (package): 72476-528-04
ndc (product): 72476-528
ndc11 (package): 72476052804
spl id: 353b6d69-568e-42c7-bcf9-1f16e2263dc4
spl set id: 338ca589-91ff-30ed-e063-6294a90a243a

Reported adverse events (FAERS/openFDA)#

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