Stomach Relief

Manufacturer
Demoulas Super Markets Inc | AptaPharma Inc.
Effective date
2023-12-29
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:06:00

Label at a glance#

ProductStomach Relief Maximum Strength
Active ingredientBISMUTH SUBSALICYLATE
Label structure18 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.

SPL UNCLASSIFIED SECTION

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

Slop 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, xanthan gum

OTC - QUESTIONS SECTION

Questions? 1-877-798-5944

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MARKET
BASKET®
"MORE FOR YOUR DOLLAR"

*COMPARE TO
The active ingredient in
PEPTO-BISMOL™ Maximum Strength

Stomach Relief↓
MAXIMUM STRENGTH

Bismuth Subsalicylate
Antidiarrheal / Upset Stomach Reliever

5 Symptom Relief of:
• Nausea           • Upset Stomach
• Heartburn       • Diarrhea
• Indigestion

8 FL OZ (237 mL)

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

*This product is not manufactured or distributed by Procter & Gamble,
Inc., the distributor of Pepto-Bismol™​.

DISTRIBUTED BY                                                         Made in USA
DEMOULAS SUPERMARKETS INC.                         LR·089 REV01
875 EAST STREET
TEWKSBURY, MA 01876

0   49705 73076   8                                                             PEEL

                                                                                          HERE  

↓Principal Display Label↓

53942-558-26 Max 8OZ53942-558-26 Max 8OZ

                                              Stomach Relief, Maximum Strength by Market Basket®

res

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
53942-558-26Stomach ReliefMaximum Strength237 mL in 1 BOTTLESUSPENSION2372

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53942-558STOMACH RELIEF MAXIMUM STRENGTH (BISMUTH SUBSALICYLATE) SUSPENSION [DEMOULAS SUPER MARKETS INC]2Current NDC, Legacy NDC, 1 package rows20231230_b2d55045-d4a4-4167-a20c-42932f35bab2.zip

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
53942-55853942-558-26

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 Maximum StrengthBISMUTH SUBSALICYLATEDemoulas Super Markets Incb2d55045-d4a4-4167-a20c-42932f35bab22023-12-29WarningsExact identifier
ndc (package): 53942-558-26
ndc (product): 53942-558
ndc11 (package): 53942055826
spl id: 9c832971-fd38-4183-acd5-d520aae9c8f6
spl set id: b2d55045-d4a4-4167-a20c-42932f35bab2

Reported adverse events (FAERS/openFDA)#

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