Maximum strength Stomach Relief

Manufacturer
WinCo Foods, LLC
Effective date
2014-11-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:41:04

Label at a glance#

ProductMaximum strength Stomach Relief
Active ingredientBISMUTH SUBSALICYLATE
Label structure8 sections

Indications and uses

relieves: diarrhea heartburn indigestion nausea upset stomach associated with these symptoms

Dosage and administration

shake well before use for accurate dosing, use dose cup adults and children 12 years and over: 1 dose (2 tbsp or 30 mL) every hour as needed do not exceed 4 doses (8 tbsp or 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 clear fluids to help prevent dehydration caused by diarrhea

Storage and handling

each Tbsp contains: sodium 5 mg, salicylate 236 mg, potassium 15 mg protect from freezing avoid excessive heat (over 104 o F or 40 o C) TAMPER EVIDENT: Do not use if imprinted shrinkband is missing or broken .

Label contents#

Full prescribing information#

Active ingredient (in each 15 mL tbsp)

OTC - ACTIVE INGREDIENT SECTION

Bismuth subsalicylate 525 mg

Purpose

OTC - PURPOSE SECTION

Upset stomach reliever and anti-diarrheal

Uses

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 children 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

  • bloody or black stool
  • an ulcer
  • 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 taking any drug for

OTC - ASK DOCTOR/PHARMACIST SECTION

  • 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 a 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, ask a health professional before use. Keep out of reach of children.

OTC - PREGNANCY OR BREAST FEEDING SECTION

In case of overdose, get medical help or contact a Poison control center  immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • shake well before use
  • for accurate dosing, use dose cup
  • adults and children 12 years and over: 1 dose (2 tbsp or 30 mL) every hour as needed
  • do not exceed 4 doses (8 tbsp or 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 clear fluids to help prevent dehydration caused by diarrhea

Other information

STORAGE AND HANDLING SECTION

  • each Tbsp contains: sodium 5 mg, salicylate 236 mg, potassium 15 mg
  • protect from freezing
  • avoid excessive heat (over 104oF or 40oC)
  • TAMPER EVIDENT: Do not use if imprinted shrinkband is missing or broken.

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzoic acid, D&C red 22, D&Cred 28, flavor, hydroxy ethyl cellulose, potassium hydroxide, purified water, saccharin sodium, salicylic acid, simethicone, xanthan gum.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

*Compare to the active ingredient in PEPTO-BISMOL® Maximum Strength

Maximum Strength Stomach Relief

Bismuth Subsalicylate / Upset Stomach Reliever & Anti-diarrheal

Soothing Relief for: Upset Stomach, Indigestion, Nausea, Heartburn & Diarrhea

8 FL OZ (236 mL)

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308763bismuth subsalicylate 1050 MG in 30 mL Oral SuspensionPSN1
308763bismuth subsalicylate 35 MG/ML Oral SuspensionSCD1
308763bismuth subsalicylate 1050 MG per 30 ML Oral SuspensionSY1
308763bismuth subsalicylate 525 MG per 15 ML Oral SuspensionSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BISMUTH CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

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
67091-234-232020-01-31C16284748780-19d75b9d0-be7e-f424-e053-dadaa90a57ceMaximum Strength Stomach Relief Liquid

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67091-234-23Maximum strength Stomach Relief236 mL in 1 BOTTLELIQUID2361

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67091-234MAXIMUM STRENGTH STOMACH RELIEF (BISMUTH SUBSALICYLATE) LIQUID [WINCO FOODS, LLC]1Legacy NDC, 1 package rows20141212_f3323f03-eea3-49cf-acef-66873ae0eef2.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BISMUTH SUBSALICYLATEACTIVE INGREDIENT62TEY51RR11
BISMUTH CATIONACTIVE MOIETYZS9CD1I8YE1
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIM1
D&C RED NO. 22INACTIVE INGREDIENT1678RKX8RT1
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NH1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1O1
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)INACTIVE INGREDIENTS38J6RZN161
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4T1
SACCHARIN SODIUM DIHYDRATEINACTIVE INGREDIENTSB8ZUX40TY1
SALICYLIC ACIDINACTIVE INGREDIENTO414PZ4LPZ1
WATERINACTIVE INGREDIENT059QF0KO0R1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEE1

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
67091-23467091-234-23

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

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 3 · 130 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
D&C RED NO. 28D&C RED NO. 28767IP0Y5NHPOWDER, FOR SUSPENSION / ORAL0.7 mg/5mlExact identifier — unii candidate
11 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESUSPENSION / RECTAL452 mgExact identifier — unii candidate
29 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEENEMA / RECTAL150 mgExact identifier — unii candidate
29 equally ranked IID candidates
D&C RED NO. 28D&C RED NO. 28767IP0Y5NHCAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
11 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16TABLET, CHEWABLE / ORAL5.9 mgExact identifier — unii candidate
15 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMMOUTHWASH / BUCCALNAExact identifier — unii candidate
23 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATESACCHARIN SODIUMSB8ZUX40TYPASTE / ORAL3 mgExact identifier — unii candidate
34 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATESACCHARIN SODIUMSB8ZUX40TYGRANULE, FOR SOLUTION / ORAL5.5 mg/120mlExact identifier — unii candidate
34 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATESACCHARIN SODIUMSB8ZUX40TYSYRUP / ORAL24 mgExact identifier — unii candidate
34 equally ranked IID candidates
D&C RED NO. 28D&C RED NO. 28767IP0Y5NHCAPSULE, DELAYED RELEASE / ORAL1 mgExact identifier — unii candidate
11 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATESACCHARIN SODIUMSB8ZUX40TYTABLET / ORAL43 mgExact identifier — unii candidate
34 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMINJECTION, SOLUTION / INTRAMUSCULAR0.2 %w/vExact identifier — unii candidate
23 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEPOWDER / ORAL275 mgExact identifier — unii candidate
29 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESOLUTION, GEL FORMING, EXTENDED RELEASE / OPHTHALMIC0.6 %w/wExact identifier — unii candidate
29 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATESACCHARIN SODIUMSB8ZUX40TYTABLET, ORALLY DISINTEGRATING / ORAL10 mgExact identifier — unii candidate
34 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATESACCHARIN SODIUMSB8ZUX40TYPOWDER, FOR SUSPENSION / ORAL85 mgExact identifier — unii candidate
34 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16SOLUTION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
15 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESUSPENSION / TOPICAL0.11 %w/vExact identifier — unii candidate
29 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMAEROSOL, FOAM / TOPICAL1 mgExact identifier — unii candidate
23 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16GEL / TOPICAL4 mgExact identifier — unii candidate
15 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATESACCHARIN SODIUMSB8ZUX40TYAEROSOL, METERED / RESPIRATORY (INHALATION)0.05 %w/wExact identifier — unii candidate
34 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEETROCHE / ORAL948 mgExact identifier — unii candidate
29 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMCONCENTRATE / ORAL12.5 mg/5mlExact identifier — unii candidate
23 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMTABLET, COATED / ORALNAExact identifier — unii candidate
23 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMTABLET, FILM COATED / ORALNAExact identifier — unii candidate
23 equally ranked IID candidates
D&C RED NO. 28D&C RED NO. 28767IP0Y5NHAEROSOL / TOPICALNAExact identifier — unii candidate
11 equally ranked IID candidates
D&C RED NO. 22D&C RED NO. 221678RKX8RTTABLET, DELAYED RELEASE / ORAL0.38 mgExact identifier — unii candidate
5 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMSUSPENSION / RECTAL0.1 %w/wExact identifier — unii candidate
23 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATESACCHARIN SODIUMSB8ZUX40TYOINTMENT / DENTALNAExact identifier — unii candidate
34 equally ranked IID candidates
D&C RED NO. 22D&C RED NO. 221678RKX8RTSUSPENSION / ORALNAExact identifier — unii candidate
5 equally ranked IID candidates
D&C RED NO. 22D&C RED NO. 221678RKX8RTCAPSULE / ORAL0.02 mgExact identifier — unii candidate
5 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATESACCHARIN SODIUMSB8ZUX40TYINJECTION / INTRAMUSCULAR22 mgExact identifier — unii candidate
34 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATESACCHARIN SODIUMSB8ZUX40TYINJECTION / INTRAVENOUS22 mgExact identifier — unii candidate
34 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEETABLET, ORALLY DISINTEGRATING / ORAL0.15 mgExact identifier — unii candidate
29 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATESACCHARIN SODIUMSB8ZUX40TYSOLUTION / RECTAL665 mgExact identifier — unii candidate
34 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESUSPENSION / OPHTHALMIC2 mgExact identifier — unii candidate
29 equally ranked IID candidates
POTASSIUM HYDROXIDEPOTASSIUM HYDROXIDEWZH3C48M4TSOLUTION / TOPICAL14.02 %w/wExact identifier — unii candidate
13 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMGEL / TOPICAL0.1 %w/wExact identifier — unii candidate
23 equally ranked IID candidates
D&C RED NO. 28D&C RED NO. 28767IP0Y5NHSOAP / TOPICALNAExact identifier — unii candidate
11 equally ranked IID candidates
POTASSIUM HYDROXIDEPOTASSIUM HYDROXIDEWZH3C48M4TGEL / TOPICAL3 mgExact identifier — unii candidate
13 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMSOLUTION / IRRIGATION0.02 %w/vExact identifier — unii candidate
23 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATESACCHARIN SODIUMSB8ZUX40TYSUSPENSION / RECTAL290 mgExact identifier — unii candidate
34 equally ranked IID candidates
POTASSIUM HYDROXIDEPOTASSIUM HYDROXIDEWZH3C48M4TINJECTION / INTRAVENOUSADJ PHExact identifier — unii candidate
13 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMGEL / RECTAL11 mgExact identifier — unii candidate
23 equally ranked IID candidates
POTASSIUM HYDROXIDEPOTASSIUM HYDROXIDEWZH3C48M4TPASTILLE / ORALADJ PHExact identifier — unii candidate
13 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATESACCHARIN SODIUMSB8ZUX40TYCAPSULE / ORAL24 mgExact identifier — unii candidate
34 equally ranked IID candidates
POTASSIUM HYDROXIDEPOTASSIUM HYDROXIDEWZH3C48M4TCREAM / VAGINAL3 mgExact identifier — unii candidate
13 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMAEROSOL, FOAM / VAGINAL0.1 %w/wExact identifier — unii candidate
23 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMCREAM / TOPICAL6 mgExact identifier — unii candidate
23 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16SYRUP / ORAL2 mg/5mlExact identifier — unii candidate
15 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMCREAM / VAGINAL10 mgExact identifier — unii candidate
23 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16SOLUTION / ORAL3 mgExact identifier — unii candidate
15 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATESACCHARIN SODIUMSB8ZUX40TYOINTMENT / TOPICALNAExact identifier — unii candidate
34 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATESACCHARIN SODIUMSB8ZUX40TYTABLET / SUBLINGUAL7 mgExact identifier — unii candidate
34 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEGRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL2350 mgExact identifier — unii candidate
29 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATESACCHARIN SODIUMSB8ZUX40TYTABLET, FOR SUSPENSION / ORAL6 mgExact identifier — unii candidate
34 equally ranked IID candidates
D&C RED NO. 28D&C RED NO. 28767IP0Y5NHTABLET / ORALNAExact identifier — unii candidate
11 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16SUSPENSION / TOPICAL0.69 %w/vExact identifier — unii candidate
15 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESOLUTION / OPHTHALMIC0.6 %w/vExact identifier — unii candidate
29 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16LOTION / TOPICAL0.2 %w/vExact identifier — unii candidate
15 equally ranked IID candidates

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
61b94eed-aada-4453-8659-4d9f57705d0bf3323f03-eea3-49cf-acef-66873ae0eef22014-11-25WarningsExact identifier
spl id: 61b94eed-aada-4453-8659-4d9f57705d0b
spl set id: f3323f03-eea3-49cf-acef-66873ae0eef2

Reported adverse events (FAERS/openFDA)#

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