Bismutina

Manufacturer
Menper Distributors, Inc. | RNV, LLC
Effective date
2025-07-22
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:08:12

Label at a glance#

ProductBismutina
Active ingredientBISMUTH SUBSALICYLATE
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients

Bismuth Subsalicylate 525 mg

OTC - PURPOSE SECTION

Purpose

Upset Stomach Reliever and Antidiarrheal

INDICATIONS & USAGE SECTION

Uses

relieves

  • traveler's diarrhea
  • diarrhea
  • upset stomach due to overindulgence in food and drink, including:
  • heartburn
  • 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 there 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 

  • an ulcer
  • a bleeding problem
  • bloody or black stool

Ask a doctor before use if you have 

  • fever
  • mucus in the stool

Ask a doctor or pharmacist before use if you are taking any drug for 

  • anticoagulation (thinning the blood)
  • diabetes
  • gout
  • arthritis

When using this product, a temporary, but harmless, darking of the stool and/or tongue may occur.

Stop use and ask a doctor if

  • symptoms get worse or last for more than two 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 reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions

  • drink plenty of clear fluids to help prevent dehydration cause by diarrhea
  • shake well before use
  • adults and children 12 years of age and over:
  • 2 tablespoonfuls (30 mL) every 1/2 hour or 4 tablespoonfuls (60 mL) every hour as needed for diarrhea/traveler's diarrhea  
  • 2 tablespoonfuls (30 mL) every 1/2 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
  • do not exceed 8 doses (16 tablesproonfuls or 240 mL) in 24 hours
  • use until diarrhea stops but not more than 2 days
  • Children under 12 years: ask a doctor

INACTIVE INGREDIENT SECTION

Inactive ingredients

benzoic acid, citric acid, FD&C yellow #5, flavor, salicylic acid, sodium citrate, sodium salicylate, sorbic acid, sucralose, water, xanthan gum

OTC - QUESTIONS SECTION

Questions? call 1-800-560-5223 M-F 9 AM to 5 PM Eastern Time

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

bismutinabismutina

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308762bismuth subsalicylate 525 MG in 30 mL Oral SuspensionPSN3
308762bismuth subsalicylate 17.5 MG/ML Oral SuspensionSCD3
308762bismuth subsalicylate 1.75 % Oral SuspensionSY3
308762bismuth subsalicylate 262 MG per 15 ML Oral SuspensionSY3
308762bismuth subsalicylate 524 MG per 30 ML Oral SuspensionSY3
308762bismuth subsalicylate 525 MG per 30 ML Oral SuspensionSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53145-475-082023-07-28C16284748780-10191ceaa-653d-198a-e063-dbdaa90aec3eBismutina

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53145-475-08Bismutina240 mL in 1 BOTTLELIQUID2403

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53145-47553145-475-08

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

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
BismutinaBISMUTH SUBSALICYLATEMenper Distributors, Inc.14bbbdbb-87c8-47a9-9147-7e0f1b75c7b92025-07-22WarningsExact identifier
ndc (package): 53145-475-08
ndc (product): 53145-475
ndc11 (package): 53145047508
spl id: 3a8b33c7-04b9-345d-e063-6294a90abba9
spl set id: 14bbbdbb-87c8-47a9-9147-7e0f1b75c7b9

Reported adverse events (FAERS/openFDA)#

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