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#
Contacts and useful links#
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
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 308762 | bismuth subsalicylate 525 MG in 30 mL Oral Suspension | PSN | 3 |
| 308762 | bismuth subsalicylate 17.5 MG/ML Oral Suspension | SCD | 3 |
| 308762 | bismuth subsalicylate 1.75 % Oral Suspension | SY | 3 |
| 308762 | bismuth subsalicylate 262 MG per 15 ML Oral Suspension | SY | 3 |
| 308762 | bismuth subsalicylate 524 MG per 30 ML Oral Suspension | SY | 3 |
| 308762 | bismuth subsalicylate 525 MG per 30 ML Oral Suspension | SY | 3 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e2db08c6-133f-4f4f-afb4-e90a2418d6f6 | Product name | 1 | 20230320 |
| c6f86816-7da6-43ea-8c25-ac9758311cc5 | Product name | 1 | 20220118 |
| ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906 | Product name | 7 | 20210625 |
| f52be47f-7aa7-46c0-b1fa-50c18dd50206 | Product name | 1 | 20201029 |
| dea2eded-d1e7-46bb-9a3d-f8dc20de6277 | Product name | 1 | 20190408 |
| 11ed6f83-cdd2-4637-8379-b1a1d3ae3cde | Product name | 1 | 20181101 |
| 86c45a79-b9f0-4476-a27c-6e10db098497 | Product name | 1 | 20180125 |
| 252e11b6-1a9a-4283-a242-df2c129c496d | Product name | 3 | 20170717 |
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 53145-475-08 | 2023-07-28 | C162847 | 48780-1 | 0191ceaa-653d-198a-e063-dbdaa90aec3e | Bismutina |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53145-475-08 | Bismutina | 240 mL in 1 BOTTLE | LIQUID | 240 | 3 |
Products#
Every source-derived product name is available through these pages.
- Bismutina
- Bismuth subsalicylate
- BENZOIC ACID
- ANHYDROUS CITRIC ACID
- FD&C YELLOW NO. 5
- SALICYLIC ACID
- SODIUM CITRATE
- SODIUM SALICYLATE
- SORBIC ACID
- SUCRALOSE
- WATER
- XANTHAN GUM
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 53145-475 | 53145-475-08 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| BENZOIC ACID | 8SKN0B0MIM | IACT |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| FD&C YELLOW NO. 5 | I753WB2F1M | IACT |
| SALICYLIC ACID | O414PZ4LPZ | IACT |
| SODIUM CITRATE | 1Q73Q2JULR | IACT |
| SODIUM SALICYLATE | WIQ1H85SYP | IACT |
| SORBIC ACID | X045WJ989B | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| WATER | 059QF0KO0R | IACT |
| XANTHAN GUM | TTV12P4NEE | IACT |
| BISMUTH SUBSALICYLATE | 62TEY51RR1 | ACTIB |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Bismutina | BISMUTH SUBSALICYLATE | Menper Distributors, Inc. | 14bbbdbb-87c8-47a9-9147-7e0f1b75c7b9 | 2025-07-22 | Warnings | 53145-475-08 53145-475 53145047508 3a8b33c7-04b9-345d-e063-6294a90abba9 14bbbdbb-87c8-47a9-9147-7e0f1b75c7b9 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
