Pepto-Bismol® Tablets

Manufacturer: The Procter & Gamble Manufacturing Company
Effective date: 2023-10-12
Label type: HUMAN OTC DRUG LABEL
Version: 13
Source: legacy-cache
Hydrated at: 2026-08-01 21:24:17

Label at a glance#

ProductPepto-Bismol

Active ingredientBISMUTH SUBSALICYLATE

Label structure20 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 (1 dose) every ½ hour or 4 tablets (2 doses) every hour as needed for diarrhea 2 tablets (1 dose) every ½ 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: ask a doctor drink plenty of cle...

Storage and handling

each tablet contains : calcium 140 mg, magnesium 9 mg salicylate 101 mg 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 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

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 or last more than 2 days
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

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 ½ 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: 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, magnesium 9 mg
salicylate 101 mg
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, flavor, magnesium stearate, mannitol, povidone, saccharin sodium, talc

Questions?

OTC - QUESTIONS SECTION

1-800-717-3786

SPL UNCLASSIFIED SECTION

TAMPER EVIDENT: Do not use if the printed inner wrap is broken or missing.

SPL UNCLASSIFIED SECTION

MADE IN MEXICO

DIST. BY PROCTER & GAMBLE

CINCINNATI OH 45202

PRINCIPAL DISPLAY PANEL - 12 Chewable Tablet Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pepto
Bismol®

Bismuth Subsalicylate
Upset Stomach Reliever/ Antidiarrheal

CHEWABLES

5 SYMPTOM

RELIEF

NAUSEA
HEARTBURN
INDIGESTION
UPSET STOMACH
DIARRHEA

12 CHEWABLE TABLETS

477

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
37000-477-01	2021-02-12	C162847	48780-1	ba0f9c33-404d-a910-e053-dadaa90a0b85	Pepto-Bismol® Tablets
37000-477-09	2021-02-12	C162847	48780-1	ba0f9c33-404d-a910-e053-dadaa90a0b85	Pepto-Bismol® Tablets
37000-477-10	2021-02-12	C162847	48780-1	ba0f9c33-404d-a910-e053-dadaa90a0b85	Pepto-Bismol® Tablets
37000-477-12	2021-02-12	C162847	48780-1	ba0f9c33-404d-a910-e053-dadaa90a0b85	Pepto-Bismol® Tablets
37000-477-24	2021-02-12	C162847	48780-1	ba0f9c33-404d-a910-e053-dadaa90a0b85	Pepto-Bismol® Tablets
37000-477-01	2021-01-29	C162847	48780-1	ba0f9c33-404d-a910-e053-dadaa90a0b85	Pepto-Bismol® Tablets
37000-477-09	2021-01-29	C162847	48780-1	ba0f9c33-404d-a910-e053-dadaa90a0b85	Pepto-Bismol® Tablets
37000-477-10	2021-01-29	C162847	48780-1	ba0f9c33-404d-a910-e053-dadaa90a0b85	Pepto-Bismol® Tablets
37000-477-12	2021-01-29	C162847	48780-1	ba0f9c33-404d-a910-e053-dadaa90a0b85	Pepto-Bismol® Tablets
37000-477-24	2021-01-29	C162847	48780-1	ba0f9c33-404d-a910-e053-dadaa90a0b85	Pepto-Bismol® Tablets

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
37000-477-09	EA - Each	37000-477	0242e6e2-de1b-426d-afce-d5e27e0ea3b0	1	2015-10-02
37000-477-10	EA - Each	37000-477	e4fa3a27-8011-4582-8a10-be0ed001120b	1	2015-10-02
37000-477-12	EA - Each	37000-477	de063b90-0b74-4b42-881b-efa0a8f316e6	1	2015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Bismuth subsalicylate	ACTIVE INGREDIENT	62TEY51RR1	1
bismuth subsalicylate	ACTIVE MOIETY	62TEY51RR1	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
povidone	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 · 10 matching rows.

Pepto-Bismol
Bismuth subsalicylate
MAGNESIUM STEARATE
MANNITOL
POVIDONE
D&C RED NO. 27 ALUMINUM LAKE
SACCHARIN SODIUM
TALC
SALICYLIC ACID
CALCIUM CARBONATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
37000-477	37000-477-01, 37000-477-12, 37000-477-09, 37000-477-10, 37000-477-90

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
MAGNESIUM STEARATE	70097M6I30	IACT
MANNITOL	3OWL53L36A	IACT
POVIDONE	FZ989GH94E	IACT
D&C RED NO. 27 ALUMINUM LAKE	ZK64F7XSTX	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT
TALC	7SEV7J4R1U	IACT
BISMUTH SUBSALICYLATE	62TEY51RR1	ACTIB
CALCIUM CARBONATE	H0G9379FGK	IACT

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
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	POWDER / ORAL		25 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
talc	TALC	7SEV7J4R1U	TABLET, DELAYED RELEASE PARTICLES / ORAL		56 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	IMPLANT / SUBCUTANEOUS	0.5 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
D&C Red No. 27	D&C RED NO. 27	2LRS185U6K	TABLET, CHEWABLE / ORAL		7 mg	Exact identifier — unii candidate 4 equally ranked IID candidates
povidone	POVIDONE	FZ989GH94E	SOLUTION / OPHTHALMIC	1.8 %w/v		Exact identifier — unii candidate 30 equally ranked IID candidates
calcium carbonate	CALCIUM CARBONATE	H0G9379FGK	CAPSULE, DELAYED RELEASE / ORAL		20 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
povidone	POVIDONE	FZ989GH94E	SOLUTION / ORAL		3000 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
D&C Red No. 27	D&C RED NO. 27	2LRS185U6K	POWDER, FOR SUSPENSION / ORAL	1.67 mg/5ml		Exact identifier — unii candidate 4 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	SUSPENSION / ORAL		64 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
mannitol	MANNITOL	3OWL53L36A	POWDER, FOR SUSPENSION / INTRAMUSCULAR	6.75 %w/v		Exact identifier — unii candidate 65 equally ranked IID candidates
povidone	POVIDONE	FZ989GH94E	FILM, EXTENDED RELEASE / TRANSDERMAL	NA		Exact identifier — unii candidate 30 equally ranked IID candidates
mannitol	MANNITOL	3OWL53L36A	SUSPENSION/ DROPS / TOPICAL	0.3 %w/v		Exact identifier — unii candidate 65 equally ranked IID candidates
povidone	POVIDONE	FZ989GH94E	TABLET / ORAL		216 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
mannitol	MANNITOL	3OWL53L36A	TABLET, CHEWABLE / ORAL		3726 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	INSERT / VAGINAL		69 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
talc	TALC	7SEV7J4R1U	OINTMENT / TOPICAL	74.6 %w/w		Exact identifier — unii candidate 35 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	IMPLANT / INTRAVITREAL	NA		Exact identifier — unii candidate 39 equally ranked IID candidates
saccharin sodium	SACCHARIN SODIUM	SB8ZUX40TY	INJECTION / INTRAMUSCULAR		22 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
povidone	POVIDONE	FZ989GH94E	TROCHE / ORAL	30 mg		Exact identifier — unii candidate 30 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	POWDER, FOR SOLUTION / ORAL		3767 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
talc	TALC	7SEV7J4R1U	CAPSULE, COATED / ORAL		87 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
saccharin sodium	SACCHARIN SODIUM	SB8ZUX40TY	TABLET / ORAL		43 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
saccharin sodium	SACCHARIN SODIUM	SB8ZUX40TY	ELIXIR / ORAL	15 mg/5ml		Exact identifier — unii candidate 34 equally ranked IID candidates
saccharin sodium	SACCHARIN SODIUM	SB8ZUX40TY	TABLET / BUCCAL	0.4 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
mannitol	MANNITOL	3OWL53L36A	SUSPENSION, EXTENDED RELEASE / ORAL	2464.6 mg		Exact identifier — unii candidate 65 equally ranked IID candidates
saccharin sodium	SACCHARIN SODIUM	SB8ZUX40TY	SOLUTION / ORAL		665 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
saccharin sodium	SACCHARIN SODIUM	SB8ZUX40TY	SOLUTION / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 34 equally ranked IID candidates
talc	TALC	7SEV7J4R1U	CAPSULE, DELAYED RELEASE / ORAL		420 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, ORALLY DISINTEGRATING / ORAL		187 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
povidone	POVIDONE	FZ989GH94E	DROPS / ORAL	NA		Exact identifier — unii candidate 30 equally ranked IID candidates
talc	TALC	7SEV7J4R1U	CAPSULE / ORAL		729 mg	Exact identifier — unii candidate 35 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
mannitol	MANNITOL	3OWL53L36A	INJECTION / SUBCUTANEOUS		675 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
mannitol	MANNITOL	3OWL53L36A	SOLUTION, CONCENTRATE / INTRAVENOUS		220 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
mannitol	MANNITOL	3OWL53L36A	INJECTION, SUSPENSION / INTRAMUSCULAR		71 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
povidone	POVIDONE	FZ989GH94E	TABLET, FILM COATED / ORAL	240 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
povidone	POVIDONE	FZ989GH94E	TABLET, COATED / ORAL	49.2 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
talc	TALC	7SEV7J4R1U	TABLET, EXTENDED RELEASE / ORAL		300 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
povidone	POVIDONE	FZ989GH94E	TABLET / SUBLINGUAL	6 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
talc	TALC	7SEV7J4R1U	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii candidate 35 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		53 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
talc	TALC	7SEV7J4R1U	TABLET, CHEWABLE / ORAL		202 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
mannitol	MANNITOL	3OWL53L36A	SOLUTION / SUBCUTANEOUS	4.54 %w/v		Exact identifier — unii candidate 65 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	CAPSULE, EXTENDED RELEASE / ORAL		117 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	TABLET / SUBLINGUAL	17.5 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
saccharin sodium	SACCHARIN SODIUM	SB8ZUX40TY	TABLET / SUBLINGUAL		7 mg	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
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	CAPSULE / ORAL	256.4 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
povidone	POVIDONE	FZ989GH94E	SUSPENSION / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 30 equally ranked IID candidates
saccharin sodium	SACCHARIN SODIUM	SB8ZUX40TY	TABLET / RECTAL	0.6 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
calcium carbonate	CALCIUM CARBONATE	H0G9379FGK	TABLET, FILM COATED / ORAL		300 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
saccharin sodium	SACCHARIN SODIUM	SB8ZUX40TY	TABLET, ORALLY DISINTEGRATING / ORAL		10 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
talc	TALC	7SEV7J4R1U	TABLET / BUCCAL	15 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
talc	TALC	7SEV7J4R1U	TABLET, FOR SUSPENSION / ORAL		24 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
povidone	POVIDONE	FZ989GH94E	SUSPENSION / OPHTHALMIC	1.8 %w/v		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
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	PELLET / ORAL		24 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
talc	TALC	7SEV7J4R1U	POWDER, FOR SUSPENSION / ORAL		735 mg	Exact identifier — unii candidate 35 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
0b662eb6-8ceb-889f-e063-6294a90a3fbf			0f02f1a4-3ea4-43de-bfdb-b9cb7626f92a	2023-11-30	Warnings	Exact identifier spl set id: 0f02f1a4-3ea4-43de-bfdb-b9cb7626f92a

Reported adverse events (FAERS/openFDA)#

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