Bismuth Subsalicylate - Kesin Pharma

Manufacturer
Kesin Pharma
Effective date
2026-11-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-11-03 06:06:31

Label at a glance#

ProductBismuth Subsalicylate
Active ingredientBISMUTH SUBSALICYLATE
Label structure17 sections

Indications and uses

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

Dosage and administration

shake well before use adults and children 12 years and over: 30 mL (1 dose) every 1/2 hour or 60 mL (2 doses) every hour as needed for diarrhea/traveler’s diarrhea 30 mL (1 dose) every 1/2 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 no more than 2 days children under 12 years: ask a doctor drink plenty of ...

Label contents#

Full prescribing information#

Active ingredient (in each 15 mL dose)

OTC - ACTIVE INGREDIENT SECTION

Bismuth subsalicylate 262 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:
  • heartbun
  • indigestion
  • nausea
  • gas
  • belching
  • fullness

Warnings

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

OTC - ASK DOCTOR/PHARMACIST SECTION

if you are taking any drug for

  • anticoagulation (thinning 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

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • shake well before use
  • adults and children 12 years and over:
  • 30 mL (1 dose) every 1/2 hour or 60 mL (2 doses) every hour as needed for
  • diarrhea/traveler’s diarrhea
  • 30 mL (1 dose) every 1/2 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 no 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

OTHER SAFETY INFORMATION

  • each 15 mL dose contains: sodium 11 mg
  • salicylate 125 mg
  • protect from freezing
  • avoid excessive heat (over 104°F or 40°C)
  • Bismuth subsalicylate is a pink liquid with mint odor and available in the following:

NDC 81033-046-15: 15 mL unit-dose cup
NDC 81033-046-34: Carton containing 30 unit-dose cups of 15 mL each

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, benzoic acid, D&C Red #22, D&C Red #28, flavor, purified water, salicylic acid, sodium citrate, sodium

salicylate, sorbic acid, sucralose, xanthan gum.

Questions or comments

OTC - QUESTIONS SECTION

Call 1-833-537-4679

SPL UNCLASSIFIED SECTION

*This product is not manufactured or distributed by The Procter and Gamble Company. Pepto-Bismol® is a registered
trademark of The Procter and Gamble Company.

Distributed by:
Kesin Pharma
Oldsmar, FL 34677
PIS-046-V01
Rev. 08/2026

Kesin Pharma LogoKesin Pharma Logo

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 81033-046-34

Bismuth Subsalicylate Liquid

262 mg per 15 mL

Delivers 15 mL

30 x 15 mL Unit Dose Cups

Bismuth Carton 30 ctBismuth Carton 30 ct

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeCode 128(01)00381033046341(17)000000(10)K0000000GTIN-14: 00381033046341
GTIN-12: 381033046341
UPC-A: 381033046341
EAN-13: 0381033046341
GTIN storage (14 digits): 00381033046341
Bismuth_15mL_Carton_30ct.jpg

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81033-04681033-046-15, 81033-046-34
84379-283

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 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
Revasol Peptic ReliefBISMUTH SUBSALICYLATERnv LLC30dc3a0a-3496-4bdf-e063-6394a90a62fd2025-03-21WarningsExact identifier
ndc (product): 84379-283

Reported adverse events (FAERS/openFDA)#

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