Pepto-Bismol

Manufacturer: Savings Distributors LLC
Effective date: 2019-07-25
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:59:56

Label at a glance#

ProductPepto-Bismol

Active ingredientBISMUTH SUBSALICYLATE

Label structure10 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, magnesium 9 mg ● salicylate 101 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 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

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 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.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN 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 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, magnesium 9 mg

● salicylate 101 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, flavor, magnesium stearate, mannitol, povidone, saccharin sodium, talc

Questions?

OTC - QUESTIONS SECTION

1-800-717-3786

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
308760	bismuth subsalicylate 262 MG Oral Tablet	PSN	1
702384	Pepto-Bismol 262 MG Oral Tablet	PSN	1
702384	bismuth subsalicylate 262 MG Oral Tablet [Pepto-bismol]	SBD	1
308760	bismuth subsalicylate 262 MG Oral Tablet	SCD	1
702384	Pepto-bismol 262 MG Oral Tablet	SY	1

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
73097-010-02	2023-01-30	C162847	48780-1	f386c649-d9f7-0266-e053-dadaa90a7c1a	Pepto-Bismol
73097-010-40	2023-01-30	C162847	48780-1	f386c649-d9f7-0266-e053-dadaa90a7c1a	Pepto-Bismol
73097-010-50	2023-01-30	C162847	48780-1	f386c649-d9f7-0266-e053-dadaa90a7c1a	Pepto-Bismol

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
73097-010-02	Pepto-Bismol	2 in 1 POUCH	TABLET	2	1
73097-010-40	Pepto-Bismol	20 in 1 CARTON	TABLET	20	1
73097-010-40	Pepto-Bismol	2 in 1 POUCH	TABLET	2	1
73097-010-50	Pepto-Bismol	25 in 1 CARTON	TABLET	25	1
73097-010-50	Pepto-Bismol	2 in 1 POUCH	TABLET	2	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
73097-010	PEPTO-BISMOL (BISMUTH SUBSALICYLATE) TABLET [SAVINGS DISTRIBUTORS LLC]	1	Legacy NDC, 5 package rows	20190726_8e84b0e3-a872-5437-e053-2a95a90abd19.zip

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

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
73097-010	73097-010-40, 73097-010-02, 73097-010-50
58933-477

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
CALCIUM CARBONATE	H0G9379FGK	IACT
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

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
8e850907-6f87-33c4-e053-2a95a90a1ac1			8e84b0e3-a872-5437-e053-2a95a90abd19	2019-07-25	Warnings	Exact identifier spl id: 8e850907-6f87-33c4-e053-2a95a90a1ac1 spl set id: 8e84b0e3-a872-5437-e053-2a95a90abd19

Reported adverse events (FAERS/openFDA)#

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