Indications and uses
relieves: • diarrhea • heartburn • indigestion • nausea • upset stomach associated with these symptoms
Bismatrol
- Manufacturer
- Proficient Rx LP
- Effective date
- 2019-11-01
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 23:58:20
Label at a glance#
ProductBismatrol
Active ingredientBISMUTH SUBSALICYLATE
Label structure8 sections
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 1/2 to 1 hour as needed • do not exceed 8 doses (16 tbsp or 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
Storage and handling
• each Tbsp contains: sodium 5 mg, salicylate 130 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)
Bismuth subsalicylate 262 mg
Purpose
Upset stomach reliever and anti-diarrheal
Uses
relieves:
- diarrhea
- heartburn
- indigestion
- nausea
- upset stomach associated with these symptoms
Warnings
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
- bloody or black stool
- an ulcer
- a bleeding problem
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 of the blood)
- diabetes
- gout
- arthritis
When using this product
a temporary, but harmless darkening of the stool and/or tongue may occur
Stop use and ask a doctor if
- 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.
In case of overdose, get medical help or contact a Poison control center immediately.
Keep Out of Reach of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.
Directions
- 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 1/2 to 1 hour as needed
- do not exceed 8 doses (16 tbsp or 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
- each Tbsp contains: sodium 5 mg, salicylate 130 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
benzoic acid, D and C red 22, D and C red 28, flavor, hydroxy ethyl cellulose, potassium hydroxide, purified water, saccharin sodium, salicylic acid, simethicone, xanthan gum.
Principal Display Panel
Bismatrol
soothing, coating action provides
fast relief for heartburn, indigestion, nausea, upset stomach and diarrhea
compare to the active ingredient in pepto-bismol®
8 FL OZ (236 mL)
Relabeled by:
Proficient Rx LP
Thousand Oaks, CA 91320
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0904-1313-09 | ML - Milliliter | 0904-1313 | 56076192-e0b3-49bb-ba2d-88b6f259e9c2 | 1 | 2013-02-13 |
Products#
Every source-derived product name is available through these pages.
- Bismatrol
- Bismuth Subsalicylate
- BISMUTH CATION
- BENZOIC ACID
- D&C RED NO. 22
- D&C RED NO. 28
- HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)
- POTASSIUM HYDROXIDE
- WATER
- SACCHARIN SODIUM
- SALICYLIC ACID
- DIMETHICONE
- XANTHAN GUM
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 63187-651 | 63187-651-08 |
| 0904-1313 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| BISMUTH SUBSALICYLATE | 62TEY51RR1 | ACTIB |
| BENZOIC ACID | 8SKN0B0MIM | IACT |
| D&C RED NO. 22 | 1678RKX8RT | IACT |
| D&C RED NO. 28 | 767IP0Y5NH | IACT |
| HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) | S38J6RZN16 | IACT |
| POTASSIUM HYDROXIDE | WZH3C48M4T | IACT |
| WATER | 059QF0KO0R | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| SALICYLIC ACID | O414PZ4LPZ | IACT |
| DIMETHICONE | 92RU3N3Y1O | IACT |
| XANTHAN GUM | TTV12P4NEE | IACT |
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 |
|---|---|---|---|---|---|---|
| acfa3b01-b770-48b1-a12c-e2c922eb6246 | 6510a588-f2dc-4a71-aef0-b8fbe8fd615b | 2024-10-01 | Warnings | 6510a588-f2dc-4a71-aef0-b8fbe8fd615b |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.