Pepto-Bismol

Manufacturer: JC World Bell Wholesale Co., Inc. | Procter & Gamble Manufactura, S. de R.L. de C.V.
Effective date: 2021-10-19
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: legacy-cache
Hydrated at: 2026-08-01 22:31:49

Label at a glance#

ProductPepto-Bismol

Active ingredientBISMUTH SUBSALICYLATE

Label structure11 sections

Indications and uses

relieves travelers' diarrhea diarrhea upset stomach due to overindulgence in food and drink, including: heartburn indigestion nausea gas belching fullness

Dosage and administration

chew or dissolve in mouth adults and children 12 years and over: 2 tablets every 1/2 to 1 hour as needed do not exceed 8 doses (16 tablets) 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 tablet contains: calcium 140 mg sodium less than 1 mg salicylate 102 mg very low sodium sugar free avoid excessive heat (over 104°F or 40°C)

Contacts and useful links#

PhoneLabel contact1-800-717-3786

Websitewww.pepto-bismol.com

www.pepto-bismol.com

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Bismuth subsalicylate 262 mg

Purposes

OTC - PURPOSE SECTION

Upset stomach reliever and antidiarrheal

Uses

INDICATIONS & USAGE SECTION

relieves

travelers' diarrhea
diarrhea
upset stomach due to overindulgence in food and drink, including:
- heartburn
- indigestion
- nausea
- gas
- belching
- fullness

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

OTC - DO NOT USE SECTION

Do not use if you have

an ulcer
a bleeding problem
bloody or black stool

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

fever
mucus in the stool

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking any drug for

anticoagulation (thinning the blood)
diabetes
gout
arthritis

OTC - WHEN USING SECTION

When using this product a temporary, but harmless, darkening of the stool and/or tongue may occur

OTC - STOP USE SECTION

Stop use and ask a doctor if

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

chew or dissolve in mouth
adults and children 12 years and over: 2 tablets every 1/2 to 1 hour as needed
do not exceed 8 doses (16 tablets) 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 tablet contains: calcium 140 mg
sodium less than 1 mg
salicylate 102 mg
very low sodium
sugar free
avoid excessive heat (over 104°F or 40°C)

Inactive ingredients

INACTIVE INGREDIENT SECTION

calcium carbonate, flavor, magnesium stearate, mannitol, povidone, red 27 aluminum lake, saccharin sodium, talc

Questions?

OTC - QUESTIONS SECTION

1-800-717-3786 www.pepto-bismol.com

SPL UNCLASSIFIED SECTION

Packaged & Distributed by:

JC World bell Wholesale Co., Inc.

Hackensack. NJ 07601

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pepto-BISMOL™

BISMUTH SUBSALICYLATE
UPSET STOMACH RELIEVER/ANTIDIARRHEAL

5 SYMPTOM RELIEF
Nausea • Heartburn • Indigestion
Upset Stomach • Diarrhea

25 CHEWABLE TABLETS

PeptoLabel

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Bismuth Subsalicylate	ACTIVE INGREDIENT	62TEY51RR1	1
Salicylic Acid	ACTIVE MOIETY	O414PZ4LPZ	1
aluminum oxide	INACTIVE INGREDIENT	LMI26O6933	1
calcium carbonate	INACTIVE INGREDIENT	H0G9379FGK	1
D&C red no. 27	INACTIVE INGREDIENT	2LRS185U6K	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	1
mannitol	INACTIVE INGREDIENT	3OWL53L36A	1
povidones	INACTIVE INGREDIENT	FZ989GH94E	1
saccharin sodium	INACTIVE INGREDIENT	SB8ZUX40TY	1
talc	INACTIVE INGREDIENT	7SEV7J4R1U	1

Products#

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

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

Pepto-Bismol
Bismuth Subsalicylate
CALCIUM CARBONATE
MAGNESIUM STEARATE
MANNITOL
POVIDONE
D&C RED NO. 27
ALUMINUM OXIDE
SACCHARIN SODIUM
TALC
BISMUTH CATION
SALICYLIC ACID

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
50269-691	50269-691-25

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
Name	UNII	Kind
CALCIUM CARBONATE	H0G9379FGK	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
MANNITOL	3OWL53L36A	IACT
POVIDONE	FZ989GH94E	IACT
D&C RED NO. 27	2LRS185U6K	IACT
ALUMINUM OXIDE	LMI26O6933	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT
TALC	7SEV7J4R1U	IACT
BISMUTH SUBSALICYLATE	62TEY51RR1	ACTIB

Source Document#

Source XML

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.

Inactive ingredient links page 1 of 4 · 224 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
mannitol	MANNITOL	3OWL53L36A	POWDER, FOR SUSPENSION / INTRAMUSCULAR	6.75 %w/v		Exact identifier — unii candidate 65 equally ranked IID candidates
povidones	POVIDONE	FZ989GH94E	SOLUTION / OPHTHALMIC	1.8 %w/v		Exact identifier — unii candidate 30 equally ranked IID candidates
mannitol	MANNITOL	3OWL53L36A	INJECTION / INTRAMUSCULAR	106.6 mg		Exact identifier — unii candidate 65 equally ranked IID candidates
talc	TALC	7SEV7J4R1U	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii candidate 35 equally ranked IID candidates
mannitol	MANNITOL	3OWL53L36A	INJECTION, SUSPENSION / INTRAVENOUS	2.5 %w/v		Exact identifier — unii candidate 65 equally ranked IID candidates
talc	TALC	7SEV7J4R1U	GRANULE / ORAL		322 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
povidones	POVIDONE	FZ989GH94E	CAPSULE, EXTENDED RELEASE / ORAL		56 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
talc	TALC	7SEV7J4R1U	CAPSULE, COATED, EXTENDED RELEASE / ORAL		20 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
talc	TALC	7SEV7J4R1U	TABLET, CHEWABLE / ORAL		202 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
saccharin sodium	SACCHARIN SODIUM	SB8ZUX40TY	PASTE / ORAL		3 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
aluminum oxide	ALUMINUM OXIDE	LMI26O6933	SPONGE / TOPICAL	NA		Exact identifier — unii candidate 2 equally ranked IID candidates
saccharin sodium	SACCHARIN SODIUM	SB8ZUX40TY	PASTE / DENTAL	0.3 %w/w		Exact identifier — unii candidate 34 equally ranked IID candidates
mannitol	MANNITOL	3OWL53L36A	SOLUTION / TOPICAL	4 %w/v		Exact identifier — unii candidate 65 equally ranked IID candidates
saccharin sodium	SACCHARIN SODIUM	SB8ZUX40TY	WAFER / ORAL	8 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
povidones	POVIDONE	FZ989GH94E	TABLET / SUBLINGUAL	6 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
saccharin sodium	SACCHARIN SODIUM	SB8ZUX40TY	TABLET / SUBLINGUAL		7 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, FOR SUSPENSION / ORAL		131 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
talc	TALC	7SEV7J4R1U	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		18 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
mannitol	MANNITOL	3OWL53L36A	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS		15400 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, FILM COATED / ORAL		96 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
D&C red no. 27	D&C RED NO. 27	2LRS185U6K	TABLET / ORAL		1 mg	Exact identifier — unii candidate 4 equally ranked IID candidates
talc	TALC	7SEV7J4R1U	POWDER / TOPICAL		9235 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
mannitol	MANNITOL	3OWL53L36A	TABLET, EXTENDED RELEASE / ORAL		1086 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
saccharin sodium	SACCHARIN SODIUM	SB8ZUX40TY	OINTMENT / DENTAL	NA		Exact identifier — unii candidate 34 equally ranked IID candidates
saccharin sodium	SACCHARIN SODIUM	SB8ZUX40TY	SYRUP / ORAL		24 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	POWDER / ORAL		25 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
mannitol	MANNITOL	3OWL53L36A	TABLET, FILM COATED / ORAL		2309 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
mannitol	MANNITOL	3OWL53L36A	TABLET, ORALLY DISINTEGRATING / SUBLINGUAL	10.25 mg		Exact identifier — unii candidate 65 equally ranked IID candidates
mannitol	MANNITOL	3OWL53L36A	POWDER, FOR SUSPENSION / ORAL		7093 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
calcium carbonate	CALCIUM CARBONATE	H0G9379FGK	SOLUTION / AURICULAR (OTIC)	0.38 %w/w		Exact identifier — unii candidate 15 equally ranked IID candidates
saccharin sodium	SACCHARIN SODIUM	SB8ZUX40TY	SOLUTION / DENTAL	0.05 %w/v		Exact identifier — unii candidate 34 equally ranked IID candidates
talc	TALC	7SEV7J4R1U	PELLET / ORAL		69 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
talc	TALC	7SEV7J4R1U	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		357 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
mannitol	MANNITOL	3OWL53L36A	POWDER / ORAL		4352 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
mannitol	MANNITOL	3OWL53L36A	CAPSULE, EXTENDED RELEASE / ORAL		160 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	CREAM / TOPICAL	NA		Exact identifier — unii candidate 39 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	IMPLANT / INTRAVITREAL	NA		Exact identifier — unii candidate 39 equally ranked IID candidates
calcium carbonate	CALCIUM CARBONATE	H0G9379FGK	SOLUTION / INTRAVENOUS	4.02 %w/v		Exact identifier — unii candidate 15 equally ranked IID candidates
mannitol	MANNITOL	3OWL53L36A	SOLUTION, GEL FORMING, EXTENDED RELEASE / OPHTHALMIC	4.35 %w/w		Exact identifier — unii candidate 65 equally ranked IID candidates
mannitol	MANNITOL	3OWL53L36A	WAFER / ORAL	642 mg		Exact identifier — unii candidate 65 equally ranked IID candidates
mannitol	MANNITOL	3OWL53L36A	SOLUTION / ORAL		869 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
talc	TALC	7SEV7J4R1U	TABLET / BUCCAL	15 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
talc	TALC	7SEV7J4R1U	LOZENGE / ORAL		50 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
mannitol	MANNITOL	3OWL53L36A	SOLUTION / OPHTHALMIC	4.7 %w/v		Exact identifier — unii candidate 65 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	GRANULE, FOR SUSPENSION / ORAL		14 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
mannitol	MANNITOL	3OWL53L36A	TABLET, COATED / ORAL	177.7 mg		Exact identifier — unii candidate 65 equally ranked IID candidates
povidones	POVIDONE	FZ989GH94E	TABLET / ORAL		216 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
mannitol	MANNITOL	3OWL53L36A	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS		658 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
povidones	POVIDONE	FZ989GH94E	TABLET, FILM COATED / ORAL	240 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
calcium carbonate	CALCIUM CARBONATE	H0G9379FGK	CAPSULE, EXTENDED RELEASE / ORAL	4 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
talc	TALC	7SEV7J4R1U	TABLET, COATED / ORAL	320.75 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
mannitol	MANNITOL	3OWL53L36A	INJECTION, POWDER, FOR SUSPENSION / SUBCUTANEOUS		180 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
povidones	POVIDONE	FZ989GH94E	TABLET, FOR SUSPENSION / ORAL	2 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
talc	TALC	7SEV7J4R1U	SUSPENSION, EXTENDED RELEASE / ORAL		46 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
mannitol	MANNITOL	3OWL53L36A	SOLUTION / INTRAVENOUS		15400 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
talc	TALC	7SEV7J4R1U	TABLET, DELAYED RELEASE / ORAL		349 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
mannitol	MANNITOL	3OWL53L36A	INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS		181 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
povidones	POVIDONE	FZ989GH94E	CAPSULE / ORAL		300 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
mannitol	MANNITOL	3OWL53L36A	POWDER / RESPIRATORY (INHALATION)		6 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
mannitol	MANNITOL	3OWL53L36A	INJECTION, SOLUTION / SUBCUTANEOUS		99 mg	Exact identifier — unii candidate 65 equally ranked IID candidates

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
ceb8bf39-a6ea-01b1-e053-2a95a90ad6b5			7c6df1c8-9241-4b56-aff7-9eb4ba612de9	2021-10-19	Warnings	Exact identifier spl id: ceb8bf39-a6ea-01b1-e053-2a95a90ad6b5 spl set id: 7c6df1c8-9241-4b56-aff7-9eb4ba612de9

Reported adverse events (FAERS/openFDA)#

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