Stomach Relief, Ultra Strength

Manufacturer
Marc Glassman, Inc.
Effective date
2025-12-26
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:28:44

Label at a glance#

ProductStomach Relief, Ultra Strength
Active ingredientBISMUTH SUBSALICYLATE
Label structure16 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient
(in each 30 mL dose cup or 2 tablespoons)
Bismuth subsalicylate 1050 mg

OTC - PURPOSE SECTION

Purposes
Bismuth subsalicylate ....................... Upset stomach reliever
                                                                and antidiarrheal

INDICATIONS & USAGE SECTION

Uses relieves ■ travelers' diarrhea ■ diarrhea ■ upset stomach
due to overindulgence of food and drink including: ■ heart burn ■
indigestion ■ nausea ■ gas ■ belching

WARNINGS SECTION

Warnings
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

OTC - DO NOT USE SECTION

Do not use if you have    ■ an ulcer
■ a bleeding problem       ■ black or bloody stool

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have
■ fever ■ mucus in stool

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are
taking any drug for ■ anticoagulation (thinning of the blood)
■ diabetes ■ gout ■ arthritis

OTC - WHEN USING SECTION

When using this product a temporary, but harmless, darkening
of the stool and/or tongue may occur

OTC - STOP USE SECTION

Stop use and ask a doctor if
■ diarrhea lasts more than 2 days
■ symptoms get worse or last more than 2 days
■ ringing in the ears or loss of hearing occurs

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast feeding, ask health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical
help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions ■ Shake well before use
■ use dose cup or tablespoon (TBSP)
■ adults and children 12 years and over: 1 dose (30 mL or 2
   TBSP) every 1 hour as needed
■ do not exceed 4 doses (120 mL or 8 TBSP) in 24 hours
■ use until diarrhea stops but not more than 2 days
■ children under 12 years: ask a doctor
■ drink plenty of clear fluids to help prevent dehydration caused by diarrhea

OTHER SAFETY INFORMATION

Other information
■ each 30 mL dose cup contains: sodium 13 mg, salicylate 455 mg ■ protect
from freezing ■ avoid excessive heat (over 104°F or 40°C) ■ low sodium

INACTIVE INGREDIENT SECTION

Inactive ingredients benzoic acid, D&C red #22, D&C red #28,
flavor, purified water, saccharin sodium, salicylic acid, sodium salicylate, xantham gum

Marc's Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68998-558-28                                          * Compare to the active

                                                              ingredients in Pepto-BismolTM

                                                                             Maximum Strength

Marc's

ULTRA STRENGTH

Stomach Relief

Antidiarrheal / Upset Stomach Reliever
Bismuth subsalicylate

5 Symptoms Relief of

• Nausea             • Upset Stomach•

• Heartburn        • Diarrhea

• Indigestion

12 FL OZ (354 mL)

TAMPER EVIDENT: Do not use if imprinted shrinkband is
missing or broken

*Thls product is not manufactured or dlstnbuted by Procter & Gamble, Inc"
distributor of Pepto BismolTM

Distributed by:                                        LR-144
Marc Glassman, Inc.
West 130th Street
Cleveland, OH 44130

Lot.
Exp.

558-28558-28

558-28558-28

res

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130094442001848GTIN-13: 0094442001848
EAN-13: 0094442001848
GTIN-12: 094442001848
UPC-A: 094442001848
GTIN storage (14 digits): 00094442001848
558-28.jpg

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68998-558-282025-12-26C16284748780-1f386c649-e17b-0266-e053-dadaa90a7c1aStomach Relief, Ultra Strength
68998-558-282023-01-30C16284748780-1f386c649-e17b-0266-e053-dadaa90a7c1aStomach Relief, Ultra Strength

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68998-558-28Stomach Relief, Ultra Strength354 mL in 1 BOTTLESUSPENSION3543

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68998-55868998-558-28

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 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
Stomach Relief, Ultra StrengthBISMUTH SUBSALICYLATEMarc Glassman, Inc.8e47d007-237c-45c7-88c5-83953a06e4bd2025-12-26WarningsExact identifier
ndc (package): 68998-558-28
ndc (product): 68998-558
ndc11 (package): 68998055828
spl id: 182ef664-b0b4-47c0-9453-27bc5d80d0f0
spl set id: 8e47d007-237c-45c7-88c5-83953a06e4bd

Reported adverse events (FAERS/openFDA)#

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