Pepto-Bismol

Manufacturer: Procter & Gamble Manufacturing México, S. de R.L. de C.V.
Effective date: 2024-10-10
Label type: HUMAN OTC DRUG LABEL
Version: 7
Source: full-release
Hydrated at: 2026-06-01 00:24:16

Label at a glance#

ProductPepto-Bismol Diarrhea

Active ingredientBISMUTH SUBSALICYLATE

Label structure12 sections

Indications and uses

relieves travelers' diarrhea diarrhea

Dosage and administration

swallow with water, do not chew adults and children 12 years and over: 1 caplet every ½ hour or 2 caplets every hour as needed do not exceed 8 caplets 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 caplet contains: calcium 54 mg salicylate 199 mg very low sodium avoid excessive heat (over 104°F or 40°C)

Contacts and useful links#

PhoneLabel contact1-800-717-3786

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Bismuth subsalicylate 525 mg

Purpose

OTC - PURPOSE SECTION

Antidiarrheal

Uses

INDICATIONS & USAGE SECTION

relieves

travelers' diarrhea
diarrhea

Warnings

WARNINGS SECTION

Reye's syndrome:

SPL UNCLASSIFIED SECTION

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:

SPL UNCLASSIFIED SECTION

Contains salicylate .

Do not take if you are

allergic to salicylates (including aspirin)
taking other salicylate products

Do not use if you have

OTC - DO NOT USE SECTION

an ulcer
a bleeding problem
bloody or black stool

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

fever
mucus in the stool

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking any drug for

anticoagulation (thinning the blood)
diabetes
gout
arthritis

When using this product

OTC - WHEN USING SECTION

a temporary, but harmless, darkening of the stool and/or tongue may occur

Stop use and ask a doctor if

OTC - STOP USE SECTION

symptoms get worse
ringing in the ears or loss of hearing occurs
diarrhea lasts more than 2 days

If pregnant or breast feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OVERDOSAGE SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

swallow with water, do not chew
adults and children 12 years and over:
1 caplet every ½ hour or 2 caplets every hour as needed
do not exceed 8 caplets 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

STORAGE AND HANDLING SECTION

each caplet contains: calcium 54 mg
salicylate 199 mg
very low sodium
avoid excessive heat (over 104°F or 40°C)

Inactive ingredients

INACTIVE INGREDIENT SECTION

calcium carbonate, D&C Red No. 27 aluminum lake, magnesium stearate, mannitol, microcrystalline cellulose, polysorbate 80, povidone, silicon dioxide, sodium starch glycolate

Questions?

OTC - QUESTIONS SECTION

1-800-717-3786

SPL UNCLASSIFIED SECTION

TAMPER EVIDENT: Do not use if inner printed seal on bottle is broken or missing.

SPL UNCLASSIFIED SECTION

MADE IN MEXICO
DIST. BY PROCTER & GAMBLE,

CINCINNATI OH 45202

PRINCIPAL DISPLAY PANEL - 12 Caplet Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pepto ^®
Diarrhea

Bismuth Subsalicylate

Antidiarrheal

2x CONCENTRATED FORMULA*

COATS & KILLS BACTERIA THAT CAUSE DIARRHEA

12 CAPLETS

391

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1998447	bismuth subsalicylate 525 MG Oral Tablet	PSN	7
1998449	Pepto-Bismol ULTRA 525 MG Oral Tablet	PSN	7
1998449	bismuth subsalicylate 525 MG Oral Tablet [Pepto-bismol]	SBD	7
1998447	bismuth subsalicylate 525 MG Oral Tablet	SCD	7
1998449	Pepto-bismol 525 MG Oral Tablet	SY	7

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277	Product name	1	20190408

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
58933-391-12	2021-06-10	C162847	48780-1	ba0f9c33-10b7-a910-e053-dadaa90a0b85	Pepto Bismol ® Diarrhea Caplets
58933-391-12	2021-01-29	C162847	48780-1	ba0f9c33-10b7-a910-e053-dadaa90a0b85	Pepto Bismol ® Diarrhea Caplets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
58933-391-12	Pepto-BismolDiarrhea	12 in 1 BOTTLE	TABLET	12		7
58933-391-12	Pepto-BismolDiarrhea	1 in 1 CARTON	TABLET	1		7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58933-391	PEPTO-BISMOL DIARRHEA (BISMUTH SUBSALICYLATE) TABLET [PROCTER & GAMBLE MANUFACTURING M&EACUTE;XICO, S. DE R.L. DE C.V.]	7	Legacy NDC, 2 package rows	20241012_84ef6f9a-ba4e-66b1-e053-2991aa0a0c34.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

Pepto-Bismol Diarrhea
Bismuth subsalicylate
CALCIUM CARBONATE
MAGNESIUM STEARATE
MANNITOL
CELLULOSE, MICROCRYSTALLINE
POLYSORBATE 80
POVIDONE
D&C RED NO. 27 ALUMINUM LAKE
SODIUM STARCH GLYCOLATE TYPE A POTATO
SILICON DIOXIDE
SALICYLIC ACID

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
58933-391	58933-391-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CALCIUM CARBONATE	H0G9379FGK	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
MANNITOL	3OWL53L36A	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
POLYSORBATE 80	6OZP39ZG8H	IACT
POVIDONE	FZ989GH94E	IACT
D&C RED NO. 27 ALUMINUM LAKE	ZK64F7XSTX	IACT
SODIUM STARCH GLYCOLATE TYPE A POTATO	5856J3G2A2	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
BISMUTH SUBSALICYLATE	62TEY51RR1	ACTIB

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
24258be2-15d5-aa51-e063-6394a90a05e9			84ef6f9a-ba4e-66b1-e053-2991aa0a0c34	2024-10-10	Warnings	Exact identifier spl id: 24258be2-15d5-aa51-e063-6394a90a05e9 spl set id: 84ef6f9a-ba4e-66b1-e053-2991aa0a0c34

Reported adverse events (FAERS/openFDA)#

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