Indications and uses
relieves travelers’ diarrhea diarrhea upset stomach due to overindulgence in food and drink including: heartburn indigestion nausea gas belching fullness
Bismuth
- Manufacturer
- Safecor Health, LLC | Allegiant Health
- Effective date
- 2025-06-07
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 20:37:05
Label at a glance#
ProductBismuth
Active ingredientBISMUTH SUBSALICYLATE
Label structure9 sections
Dosage and administration
Chew or dissolve in mouth Adults and children 12 years and over : 2 tablets (1 dose) every ½ hour or 4 tablets (2 doses) every hour as needed for diarrhea 2 tablets (1 dose) every ½ hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea) Do not exceed 8 doses (16 tablets) in 24 hours Use until diarrhea stops but no more than 2 days Children under 12 years of age: ask a doctor Drink plenty...
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredient
Bismuth subsalicylate 262 mg (each tablet contains 102 mg salicylate)
Purpose
Antidiarrheal/Antacid
Uses
- relieves
- travelers’ diarrhea
- diarrhea
- upset stomach due to overindulgence in food and drink including:
- heartburn
- indigestion
- nausea
- gas
- belching
- fullness
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 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
- 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
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
When using this product
a temporary, but harmless, darkening of the stool and/or tongue may occur
If pregnant or breast-feeding
ask a health professional before use.
Keep Out of Reach of Children
In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) right away.
Directions
- Chew or dissolve in mouth
- Adults and children 12 years and over : 2 tablets (1 dose) every ½ hour or 4 tablets (2 doses) every hour as needed for diarrhea
- 2 tablets (1 dose) every ½ hour as needed for overindulgence
- (upset stomach, heartburn, indigestion, nausea)
- Do not exceed 8 doses (16 tablets) in 24 hours
- Use until diarrhea stops but no more than 2 days
- Children under 12 years of age: ask a doctor
- Drink plenty of clear fluids to help prevent dehydration caused by diarrhea
Other Information
Phenylketonurics: contains phenylalanine 1.1 mg per tablet
Calcium content per tablet: ·73 mg
• save carton for full directions and warnings
• store at room temperature 15°- 30°C (59°- 86°F)
Inactive Ingredients
acacia gum, aspartame, calcium carbonate, D&C red #27 aluminum lake, dextrates, magnesium stearate, maltodextrin, microcrystalline cellulose, peppermint flavor, silicon dioxide
BISMUTH SUBSALICYLATE
262 mg Chewable Tablet
Contains 100 Unit Dose Blisters NDC: 48433-127-01
3 48433 127 10 0
GTIN: 00348433127100
SN: 222202401
Exp: 2024-03-27
Lot: 22A0078
These unit dose packages meet USP specifications for light resistance.
The package design is not child resistant. For institutional use only.
Distributed by Safecor Health, LLC 317 New Boston St, Woburn MA 01801
06/2022 PN5728
Package/Label Principal Display Panel
Bismuth Subsalicylate
262 mg
Chewable Tablet
Mfg: Allegiant Health
Exp:02/03/24
Lot22A0016
PKG BY: Safecor Health
Woburn, MA
4843312701
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 48433-127-01 | EA - Each | 48433-127 | d4f27b6f-7f22-410c-97e3-e904fd824f22 | 1 | 2022-11-07 |
| 48433-127-10 | EA - Each | 48433-127 | 87095a11-cf6a-4ad5-9673-138a33613bd6 | 1 | 2023-10-16 |
Products#
Every source-derived product name is available through these pages.
- Bismuth
- Bismuth subsalicylate
- BISMUTH CATION
- ASPARTAME
- CALCIUM CARBONATE
- D&C RED NO. 27
- DEXTRATES
- MAGNESIUM STEARATE
- CELLULOSE, MICROCRYSTALLINE
- SILICON DIOXIDE
- ACACIA
- MALTODEXTRIN
- PEPPERMINT
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 48433-127 | 48433-127-01, 48433-127-10 |
| 69168-046 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| BISMUTH SUBSALICYLATE | 62TEY51RR1 | ACTIB |
| ASPARTAME | Z0H242BBR1 | IACT |
| CALCIUM CARBONATE | H0G9379FGK | IACT |
| D&C RED NO. 27 | 2LRS185U6K | IACT |
| DEXTRATES | G263MI44RU | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| ACACIA | 5C5403N26O | IACT |
| MALTODEXTRIN | 7CVR7L4A2D | IACT |
| PEPPERMINT | V95R5KMY2B | 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 |
|---|---|---|---|---|---|---|
| 4eb5995d-4af4-40fd-ac62-a4906fac1aea | ba4d807b-4c9b-48ba-a8ea-1f6358a825d7 | 2025-06-07 | Warnings | 4eb5995d-4af4-40fd-ac62-a4906fac1aea ba4d807b-4c9b-48ba-a8ea-1f6358a825d7 | ||
| Bismuth | BISMUTH SUBSALICYLATE | Allegiant Health | 015ca07a-f6b5-4741-a7b0-821cf6d4e418 | 2018-11-07 | Warnings | 69168-046 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.