FDA.reportPublic FDA data

Bismuth subsalicylate 525mg/30mL Suspension Regular Strength - DYE FREE

Manufacturer
Walmart Inc. | TIME CAP LABORATORIES INC | MARKSANS PHARMA LIMITED
Effective date
2026-02-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:47:07

Label at a glance#

ProductDye Free Regular Strength Stomach Relief
Active ingredientBISMUTH SUBSALICYLATE
Label structure10 sections

Indications and uses

relieves travelers’ diarrhea diarrhea upset stomach due to overindulgence in food and drink, including: heartburn indigestion nausea gas belching fullness

Dosage and administration

shake well before use only use dose cup provided adults and children 12 years and over: 30 mL (1 dose) every ½ hour or 60 mL (2 doses) every hour as needed for diarrhea / travelers’ diarrhea 30 mL (1 dose) every ½ hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea) do not exceed 8 doses (240 mL) in 24 hours use until diarrhea stops but not more than 2 days children under 12 years: ask...

Storage and handling

each 30 mL dose contains: ■ sodium 5 mg ■ salicylate 199 mg keep tightly closed protect from freezing avoid excessive heat (over 104°F or 40°C)

Label contents#

Full prescribing information#

Drug Facts

SPL UNCLASSIFIED SECTION

-

Active ingredient (in each 30 mL dose)

OTC - ACTIVE INGREDIENT SECTION

Bismuth subsalicylate 525 mg

Purpose

OTC - PURPOSE SECTION

Upset stomach reliever and antidiarrheal

Uses

INDICATIONS & USAGE SECTION

relieves

  • travelers’ diarrhea
  • diarrhea
  • upset stomach due to overindulgence in food and drink, including:

heartburn
indigestion
nausea
gas
belching
fullness

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
  • a bleeding problem
  • bloody or black stool

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 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 or last more than 2 days
  • 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 right away (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

  • shake well before use
  • only use dose cup provided
  • adults and children 12 years and over:

30 mL (1 dose) every ½ hour or 60 mL (2 doses) every hour as needed for diarrhea / travelers’ diarrhea
30 mL (1 dose) every ½ hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)

  • do not exceed 8 doses (240 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 30 mL dose contains: ■ sodium 5 mg ■ salicylate 199 mg
  • keep tightly closed
  • protect from freezing
  • avoid excessive heat (over 104°F or 40°C)

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzoic acid, flavor, glycerin, purified water, sucralose, xanthan gum

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-888-287-1915

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

bismuth-df-16oz-labelbismuth-df-16oz-label

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 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79903-427-16Dye Free Regular Strength Stomach Relief473 mL in 1 BOTTLESUSPENSION4732

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79903-42779903-427-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
SUCRALOSE96K6UQ3ZD4IACT
GLYCERINPDC6A3C0OXIACT
BISMUTH SUBSALICYLATE62TEY51RR1ACTIB
WATER059QF0KO0RIACT
XANTHAN GUMTTV12P4NEEIACT
BENZOIC ACID8SKN0B0MIMIACT

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
Dye Free Regular Strength Stomach ReliefBISMUTH SUBSALICYLATEWalmart Inc.46846abe-062d-a11f-e063-6294a90a73f32026-02-06WarningsExact identifier
ndc (package): 79903-427-16
ndc (product): 79903-427
ndc11 (package): 79903042716
spl id: 472969b5-ae52-922f-e063-6394a90a36e6
spl set id: 46846abe-062d-a11f-e063-6294a90a73f3

Reported adverse events (FAERS/openFDA)#

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