FDA.reportPublic FDA data

Pepto Relief

Manufacturer
Richmond Pharmaceuticals, Inc | Advance Pharmaceutical Inc.
Effective date
2017-10-30
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:52:49

Label at a glance#

ProductPepto Relief
Active ingredientBISMUTH SUBSALICYLATE
Label structure11 sections

Indications and uses

Controls diarrhea Relieves upset stomach due to overindulgence in food or drink

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

Label contents#

Full prescribing information#

Drug Facts

SPL UNCLASSIFIED SECTION

.

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

(in each tablet)

Bismuth subsalicylate 262 mg

Purpose

OTC - PURPOSE SECTION

Anti-diarrheal/Upset stomach reliever

Uses

INDICATIONS & USAGE SECTION

  • Controls diarrhea
  • Relieves upset stomach due to overindulgence in food or drink

Warnings

WARNINGS SECTION

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

DOSAGE & ADMINISTRATION SECTION

  • 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

SPL UNCLASSIFIED SECTION

  • Each tablet contains: calcium 77 mg, salicylate 102 mg
  • store at 15°-30°C (59°-86°F)
  • protect from moisture

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

calcium carbonate, D&C red # 27 (Al-lake), dextrose, flavor (cherry), magnesium stearate, maltodextrin, silicon dioxide, sorbitol

Questions or Comments

SPL UNCLASSIFIED SECTION

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Call 804-270-4498, 8.30 am – 4.30 pm EST Monday - Friday

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC:  54738-102-30

– 30 TABLETS

NDC: 54738-102-48- 48  TABLETS

IMG_4675IMG_4675

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308761bismuth subsalicylate 262 MG Chewable TabletPSN2
308761bismuth subsalicylate 262 MG Chewable TabletSCD2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BISMUTH CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130054738102307GTIN-13: 0054738102307
EAN-13: 0054738102307
GTIN-12: 054738102307
UPC-A: 054738102307
GTIN storage (14 digits): 00054738102307		IMG_4675.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0be8e4ae-4d57-49f3-b3a9-e4728b4e8d15Product name120240313
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54738-102-30Pepto Relief30 in 1 BOTTLETABLET, CHEWABLE302
54738-102-48Pepto Relief48 in 1 BOTTLETABLET, CHEWABLE482

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54738-102PEPTO RELIEF (BISMUTH SUBSALICYLATE) TABLET, CHEWABLE [RICHMOND PHARMACEUTICALS, INC]2Current NDC, Legacy NDC, 2 package rows20171030_a6f383b4-47f9-4837-93e2-2ca114fb20b9.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54738-102-30EA - Each54738-10246da8983-4f4e-421f-958d-fb46c3679e8712017-11-06

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54738-10254738-102-30, 54738-102-48

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
CALCIUM CARBONATEH0G9379FGKIACT
D&C RED NO. 272LRS185U6KIACT
DEXTROSEIY9XDZ35W2IACT
CHERRYBUC5I9595WIACT
MAGNESIUM STEARATE70097M6I30IACT
MALTODEXTRIN7CVR7L4A2DIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SORBITOL506T60A25RIACT
BISMUTH SUBSALICYLATE62TEY51RR1ACTIB

Source Document#

Source XML

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pepto ReliefBISMUTH SUBSALICYLATERichmond Pharmaceuticals, Inca6f383b4-47f9-4837-93e2-2ca114fb20b92017-10-30WarningsExact identifier
ndc (package): 54738-102-48
ndc (package): 54738-102-30
ndc (product): 54738-102
ndc11 (package): 54738010248
ndc11 (package): 54738010230
spl id: 5cc53a8f-4daa-7cff-e053-2991aa0a383b
spl set id: a6f383b4-47f9-4837-93e2-2ca114fb20b9

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.