Indications and uses
Controls diarrhea Relieves upset stomach due to overindulgence in food or drink
Pepto Relief
- Manufacturer
- Advance Pharmaceutical Inc.
- Effective date
- 2017-12-22
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-05-31 22:53:39
Label at a glance#
ProductPepto Relief
Active ingredientBISMUTH SUBSALICYLATE
Label structure11 sections
Dosage and administration
drink plenty of clear fluids to help prevent dehydration caused by diarrhea repeat dosage every 1/2 to 1 hour as needed do not take more than 8 doses in 24 hours use until diarrhea stops but not more than 2 days adults and children 12 years and over: 2 tablets children under 12 years: ask a doctor
Contacts and useful links#
Label contents#
Full prescribing information#
Drug Facts
.
Active Ingredient
(in each tablet)
Bismuth subsalicylate 262 mg
Purpose
Anti-diarrheal/Upset stomach reliever
Uses
- Controls diarrhea
- Relieves upset stomach due to overindulgence in food or drink
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: 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
- If you have an ulcer or 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 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.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- drink plenty of clear fluids to help prevent dehydration caused by diarrhea
- repeat dosage every 1/2 to 1 hour as needed
- do not take more than 8 doses in 24 hours
- use until diarrhea stops but not more than 2 days
- adults and children 12 years and over: 2 tablets
- children under 12 years: ask a doctor
Other Information
- Each tablet contains: calcium 77 mg, salicylate 102 mg
- store at 15°-30°C (59°-86°F)
- protect from moisture
INACTIVE INGREDIENT
calcium carbonate, D&C red # 27 (Al-lake), dextrose, flavor (cherry), magnesium stearate, maltodextrin, silicon dioxide, sorbitol
Questions or Comments
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Call 631-981-4600, 8.30 am – 4.30 pm EST Monday - Friday
Package Label
NDC: 17714-045-30 – 30 CHEWABLE TABLETS
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| BISMUTH CATION Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 0be8e4ae-4d57-49f3-b3a9-e4728b4e8d15 | Product name | 1 | 20240313 |
| dea2eded-d1e7-46bb-9a3d-f8dc20de6277 | Product name | 1 | 20190408 |
| ed912195-5da0-0f2f-6f4b-3ef17710cbe3 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 17714-045-30 | Pepto Relief | 30 in 1 BOTTLE | TABLET, CHEWABLE | 30 | 2 |
DailyMed Dashboard NDC Coverage#
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| BISMUTH SUBSALICYLATE | ACTIVE INGREDIENT | 62TEY51RR1 | 1 | |
| BISMUTH CATION | ACTIVE MOIETY | ZS9CD1I8YE | 1 | |
| CALCIUM CARBONATE | INACTIVE INGREDIENT | H0G9379FGK | 1 | |
| CHERRY | INACTIVE INGREDIENT | BUC5I9595W | 1 | |
| D&C RED NO. 27 | INACTIVE INGREDIENT | 2LRS185U6K | 1 | |
| DEXTROSE | INACTIVE INGREDIENT | IY9XDZ35W2 | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | 1 | |
| MALTODEXTRIN | INACTIVE INGREDIENT | 7CVR7L4A2D | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 1 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | 1 |
Products#
Every source-derived product name is available through these pages.
- Pepto Relief
- Bismuth subsalicylate
- CALCIUM CARBONATE
- D&C RED NO. 27
- DEXTROSE
- CHERRY
- MAGNESIUM STEARATE
- MALTODEXTRIN
- SILICON DIOXIDE
- SORBITOL
- BISMUTH CATION
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 17714-045 | 17714-045-30 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CALCIUM CARBONATE | H0G9379FGK | IACT |
| D&C RED NO. 27 | 2LRS185U6K | IACT |
| DEXTROSE | IY9XDZ35W2 | IACT |
| CHERRY | BUC5I9595W | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| MALTODEXTRIN | 7CVR7L4A2D | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| SORBITOL | 506T60A25R | IACT |
| BISMUTH SUBSALICYLATE | 62TEY51RR1 | ACTIB |
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, CHEWABLE / ORAL | 254 mg | ||
| DEXTROSE | DEXTROSE | IY9XDZ35W2 | TABLET, CHEWABLE / ORAL | 1286 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, CHEWABLE / ORAL | 254 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, CHEWABLE / ORAL | 127 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, CHEWABLE / ORAL | 127 mg | ||
| D&C RED NO. 27 | D&C RED NO. 27 | 2LRS185U6K | TABLET, CHEWABLE / ORAL | 7 mg | ||
| CALCIUM CARBONATE | CALCIUM CARBONATE | H0G9379FGK | TABLET, CHEWABLE / ORAL | 1650 mg | ||
| MALTODEXTRIN | MALTODEXTRIN | 7CVR7L4A2D | TABLET, CHEWABLE / ORAL | 292 mg | ||
| CHERRY | CHERRY | BUC5I9595W | TABLET, CHEWABLE / ORAL | NA | ||
| CALCIUM CARBONATE | CALCIUM CARBONATE | H0G9379FGK | TABLET, CHEWABLE / ORAL | 1650 mg | ||
| D&C RED NO. 27 | D&C RED NO. 27 | 2LRS185U6K | TABLET, CHEWABLE / ORAL | 7 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | TABLET, CHEWABLE / ORAL | 3555 mg | ||
| CHERRY | CHERRY | BUC5I9595W | TABLET, CHEWABLE / ORAL | NA | ||
| MALTODEXTRIN | MALTODEXTRIN | 7CVR7L4A2D | TABLET, CHEWABLE / ORAL | 292 mg | ||
| DEXTROSE | DEXTROSE | IY9XDZ35W2 | TABLET, CHEWABLE / ORAL | 1286 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | TABLET, CHEWABLE / ORAL | 3555 mg |
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 |
|---|---|---|---|---|---|---|
| Pepto Relief | BISMUTH SUBSALICYLATE | Advance Pharmaceutical Inc. | a02babe7-9255-44c7-90e1-b5ad5e59c72a | 2017-12-22 | Warnings | 17714-045-30 17714-045 17714004530 60f4322f-5cb1-096a-e053-2a91aa0a64eb a02babe7-9255-44c7-90e1-b5ad5e59c72a |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.