Indications and uses
relieves travelers’ diarrhea diarrhea upset stomach due to overindulgence in food and drink including: heartburn indigestion nausea gas belching fullness
Pep Tum
- Manufacturer
- First Aid Direct
- Effective date
- 2017-12-22
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 8
- Source
- full-release
- Hydrated at
- 2026-05-31 23:57:02
Label at a glance#
ProductPep Tum
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 1/2 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 not more than 2 days Children under 12 years of age: ask a doctor drink plen...
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredient (in each tablet)
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
- bloody or black stool
- an ulcer
- a bleeding problem
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, get medical help or contact a 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 1/2 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 not 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
Inactive Ingredients
acacia gum, aspartame, calcium carbonate, D&C red #27 aluminum lake, dextrates,
magnesium stearate, maltodextrin, microcrystalline cellulose, peppermint flavor, silicon dioxide
Other Information
- Phenylketonurics: contains phenylalanine 1.1mg per tablet
Calcium content per tablet: 73mg - store at room temperature 15°– 30°C (59°– 86°F)
- avoid excessive heat (over 40°C or 104°F)
- do not use if cellophane unit is torn
Package/Label Principal Display Panel
DailyMed RxNorm Mappings#
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| dea2eded-d1e7-46bb-9a3d-f8dc20de6277 | Product name | 1 | 20190408 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53117-046-85 | Pep Tum | 1 in 1 CELLO PACK | TABLET, CHEWABLE | 1 | 8 | |
| 53117-046-85 | Pep Tum | 30 in 1 CARTON | TABLET, CHEWABLE | 30 | 8 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Pep Tum
- Bismuth subsalicylate
- SALICYLIC ACID
- ASPARTAME
- CALCIUM CARBONATE
- D&C RED NO. 27
- DEXTRATES
- MAGNESIUM STEARATE
- CELLULOSE, MICROCRYSTALLINE
- SILICON DIOXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 53117-046 | 53117-046-85 |
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 |
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 |
|---|---|---|---|---|---|---|
| Pep Tum | BISMUTH SUBSALICYLATE | First Aid Direct | bf966e9f-2f95-41cd-a6e5-b8eb521181d8 | 2017-12-22 | Warnings | 53117-046-85 53117-046 53117004685 affef754-2097-48fc-975b-63a35c991da7 bf966e9f-2f95-41cd-a6e5-b8eb521181d8 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.