Stomach relief

Manufacturer: Strategic Sourcing Services LLC
Effective date: 2022-01-06
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: legacy-cache
Hydrated at: 2026-08-01 22:19:02

Label at a glance#

ProductStomach relief

Active ingredientBISMUTH SUBSALICYLATE

Label structure8 sections

Indications and uses

relieves: indigestion nausea heartburn diarrhea upset stomach associated with these symptoms

Dosage and administration

Swallow caplet(s) with water, do not chew adults and children 12 years and over: 2 caplets every 1/2 to 1 hour as needed do not take more than 8 doses (16 caplets) in 24 hours use until diarrhea stops but not more than 2 days children under 12 years: ask a doctor drink plenty of fluids to help prevent dehydration which may accompany diarrhea.

Storage and handling

each caplet contains: calcium 27 mg, salicylate 102 mg and sodium 2 mg very low sodium TAMPER EVIDENT: Do not use if printed seal under cap is torn or missing. store at room temperature, in a dry place

Label contents#

Full prescribing information#

Active ingredient (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Bismuth subsalicylate 262 mg

Purpose

OTC - PURPOSE SECTION

Upset stomach reliever and anti-diarrheal

Uses

INDICATIONS & USAGE SECTION

relieves:

indigestion
nausea
heartburn
diarrhea
upset stomach associated with these symptoms

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: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

bloody or black stool
an ulcer
a bleeding problem

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 taking any drug for

OTC - ASK DOCTOR/PHARMACIST SECTION

anticoagulation (thinning of 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, ask a health professional before use. Keep out of reach of children.

OTC - PREGNANCY OR BREAST FEEDING SECTION

In case of overdose, get medical help or contact a poison control center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

Swallow caplet(s) with water, do not chew
adults and children 12 years and over: 2 caplets every 1/2 to 1 hour as needed
do not take more than 8 doses (16 caplets) in 24 hours
use until diarrhea stops but not more than 2 days
children under 12 years: ask a doctor
drink plenty of fluids to help prevent dehydration which may accompany diarrhea.

Other information

STORAGE AND HANDLING SECTION

each caplet contains: calcium 27 mg, salicylate 102 mg and sodium 2 mg
very low sodium
TAMPER EVIDENT: Do not use if printed seal under cap is torn or missing.
store at room temperature, in a dry place

Inactive ingredients

INACTIVE INGREDIENT SECTION

calcium carbonate, colloidal silicon dioxide, D&C red 27 aluminum lake, magnesium stearate, mannitol, microcrystalline cellulose, polysorbate 80, sodium starch glycolate.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

sunmark

COMPARE TO PEPTO-BISMOL^® ACTIVE INGREDIENT

NDC # 49348-511-59

stomach relief

Soothing relief for upset stomach, indigestion, nausea, heartburn and diarrhea

ORIGINAL FORMULA

40 CAPLETS

image description

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49348-511-59	EA - Each	49348-511	a3f5260c-1f44-406b-885e-2f7257f6ff6e	1	2014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
BISMUTH SUBSALICYLATE	ACTIVE INGREDIENT	62TEY51RR1	1
SALICYLIC ACID	ACTIVE MOIETY	O414PZ4LPZ	1
CALCIUM CARBONATE	INACTIVE INGREDIENT	H0G9379FGK	1
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	1
D&C RED NO. 27	INACTIVE INGREDIENT	2LRS185U6K	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	1
SODIUM STARCH GLYCOLATE TYPE A CORN	INACTIVE INGREDIENT	AG9B65PV6B	1

Products#

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

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

Stomach relief
Bismuth subsalicylate
SALICYLIC ACID
BISMUTH CATION
CALCIUM CARBONATE
SILICON DIOXIDE
D&C RED NO. 27
MAGNESIUM STEARATE
POLYSORBATE 80
SODIUM STARCH GLYCOLATE TYPE A CORN
MICROCRYSTALLINE CELLULOSE
MANNITOL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
49348-511	49348-511-59

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
BISMUTH SUBSALICYLATE	62TEY51RR1	ACTIB
CALCIUM CARBONATE	H0G9379FGK	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
D&C RED NO. 27	2LRS185U6K	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
POLYSORBATE 80	6OZP39ZG8H	IACT
SODIUM STARCH GLYCOLATE TYPE A CORN	AG9B65PV6B	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT
MANNITOL	3OWL53L36A	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 · 185 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
CALCIUM CARBONATE	CALCIUM CARBONATE	H0G9379FGK	CAPSULE, DELAYED RELEASE / ORAL		20 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	CAPSULE, EXTENDED RELEASE / ORAL		117 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SPRAY, METERED / NASAL	0.1 mg/1ml		Exact identifier — unii candidate 78 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / BUCCAL	17.5 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GRANULE, FOR SOLUTION / ORAL	1.8 mg/120ml		Exact identifier — unii candidate 49 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	CAPSULE, DELAYED RELEASE / ORAL		23 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		336 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	CAPSULE / ORAL	256.4 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	SUSPENSION, EXTENDED RELEASE / ORAL		70 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	IMPLANT / INTRAVITREAL	NA		Exact identifier — unii candidate 39 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	GRANULE, FOR SUSPENSION / ORAL		240 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, POWDER, FOR SUSPENSION / INTRAMUSCULAR		4 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SUSPENSION / RESPIRATORY (INHALATION)		1 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	POWDER / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GRANULE, DELAYED RELEASE / ORAL	3.2 mg		Exact identifier — unii candidate 49 equally ranked IID candidates
CALCIUM CARBONATE	CALCIUM CARBONATE	H0G9379FGK	TABLET / ORAL		793 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION / INTRAVENOUS		4680 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	DROPS / AURICULAR (OTIC)	0.02 %w/w		Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, SOLUTION / INTRAMUSCULAR	5 %w/v		Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	53 mg		Exact identifier — unii candidate 78 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, DELAYED RELEASE / ORAL		40 mg	Exact identifier — unii candidate 49 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
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION / INTRASYNOVIAL	0.2 %w/v		Exact identifier — unii candidate 78 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	GRANULE, FOR SUSPENSION / ORAL		14 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	TABLET, EXTENDED RELEASE / ORAL		10 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	DROPS / ORAL	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION / INTRA-ARTICULAR		4 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	TABLET, ORALLY DISINTEGRATING / ORAL		1 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	TABLET, FILM COATED / ORAL	24 mg		Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, POWDER, FOR SUSPENSION / INTRA-ARTICULAR		5 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	CAPSULE, DELAYED RELEASE / ORAL		1060 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
CALCIUM CARBONATE	CALCIUM CARBONATE	H0G9379FGK	CAPSULE / ORAL	349.9 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	TABLET, CHEWABLE / ORAL		84 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS		900 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SUSPENSION / SUBCUTANEOUS	0.3 %w/v		Exact identifier — unii candidate 78 equally ranked IID candidates
CALCIUM CARBONATE	CALCIUM CARBONATE	H0G9379FGK	CAPSULE, EXTENDED RELEASE / ORAL	4 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	LOZENGE / ORAL		120 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	POWDER, FOR SUSPENSION / ORAL		396 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	TABLET / ORAL		233 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	INSERT / VAGINAL		8 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	POWDER / ORAL		25 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		47 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SOLUTION / OPHTHALMIC		8 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SOLUTION, GEL FORMING, EXTENDED RELEASE / OPHTHALMIC	0.05 %w/w		Exact identifier — unii candidate 78 equally ranked IID candidates
CALCIUM CARBONATE	CALCIUM CARBONATE	H0G9379FGK	SOLUTION / INTRAVENOUS	4.02 %w/v		Exact identifier — unii candidate 15 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	ELIXIR / ORAL	2.5 mg/15ml		Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SOLUTION / RECTAL		315 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	CREAM / VAGINAL	0.4 %w/w		Exact identifier — unii candidate 78 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, FILM COATED / ORAL		166 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, ORALLY DISINTEGRATING / ORAL		187 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	SYSTEM / INTRAVITREAL	0.02 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, COATED PELLETS / ORAL		69 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
CALCIUM CARBONATE	CALCIUM CARBONATE	H0G9379FGK	POWDER, DENTIFRICE / DENTAL	0.5 mg/mg		Exact identifier — unii candidate 15 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION / INTRALESIONAL		4 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	INSERT / VAGINAL		69 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
CALCIUM CARBONATE	CALCIUM CARBONATE	H0G9379FGK	GUM, CHEWING / BUCCAL		3492 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, SUSPENSION / INTRAMUSCULAR		4 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GRANULE / ORAL	5000 mg		Exact identifier — unii candidate 49 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TAMPON / VAGINAL	NA		Exact identifier — unii candidate 49 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
6216355f-c93d-4247-af6c-8799b01e60fd			e0439ad7-ce90-407f-ae50-1ec1bb11d715	2024-12-20	Warnings	Exact identifier spl set id: e0439ad7-ce90-407f-ae50-1ec1bb11d715

Reported adverse events (FAERS/openFDA)#

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