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 00:05:59

Label at a glance#

ProductStomach Relief Regular 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    525 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 1/2 to 1 hour as needed
■ do not exceed 8 doses (240 mL or 16 TBSP) in 24 hours
■ use until diarrhea stops but not more than 2 days
■ children under 12 years: ask adoctor
■ 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 256 mg ■ protect from freezing ■ avoid excessive
heat (over 104ºF or 40ºC) ■ Iow 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

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™

Stomach
Relief
REGULAR STRENGTH

Bismuth Subsalicylate
Antidiarrheal / Upset Stomach Reliever

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

12 FL OZ (354 mL)

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

*This product is not manufactured or distributed by
Proctor & Gamble, Inc., the distributor of Pepto-BismolTM

Made in USA                 LR-088   REV01
DISTRIBUTED BY
DEMOULAS SUPERMARKETS INC.
875 EAST STREET - TEWKSBURY, MA 01876

0   49705 73077   5

53942-557-28 Regulr 12OZ53942-557-28 Regulr 12OZ

                                              Stomach Relief, Regular Strength by Market Basket®

res

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308762bismuth subsalicylate 525 MG in 30 mL Oral SuspensionPSN2
308762bismuth subsalicylate 17.5 MG/ML Oral SuspensionSCD2
308762bismuth subsalicylate 1.75 % Oral SuspensionSY2
308762bismuth subsalicylate 262 MG per 15 ML Oral SuspensionSY2
308762bismuth subsalicylate 524 MG per 30 ML Oral SuspensionSY2
308762bismuth subsalicylate 525 MG per 30 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
53942-557-28Stomach ReliefRegular Strength354 mL in 1 BOTTLESUSPENSION3542

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53942-557STOMACH RELIEF REGULAR STRENGTH (BISMUTH SUBSALICYLATE) SUSPENSION [DEMOULAS SUPER MARKETS INC]2Current NDC, Legacy NDC, 1 package rows20231230_9a95d198-f3ba-4bc3-a6f1-e065eb7e86f0.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
53942-55753942-557-28

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 Regular StrengthBISMUTH SUBSALICYLATEDemoulas Super Markets Inc9a95d198-f3ba-4bc3-a6f1-e065eb7e86f02023-12-29WarningsExact identifier
ndc (package): 53942-557-28
ndc (product): 53942-557
ndc11 (package): 53942055728
spl id: 67d9d4ea-ca8d-4405-8437-578ca53ce0e9
spl set id: 9a95d198-f3ba-4bc3-a6f1-e065eb7e86f0

Reported adverse events (FAERS/openFDA)#

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