Stomach Relief

Manufacturer: SDA Laboratories, Inc.
Effective date: 2013-08-03
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:36:31

Label at a glance#

ProductStomach Relief

Active ingredientBISMUTH SUBSALICYLATE

Label structure9 sections

Indications and uses

controls diarrhea relieves upset stomach due to overindulgence in food or drink

Dosage and administration

drink plenty of clear fluids to help prevent dehydration caused by diarrhea repeat dosage every 1/2 to 1 hour as needed do not take more than 8 doses in 24 hours use untill diarrhea stops but not more than 2 days adults and children 12 years and over: 2 tablets children under 12 years: ask a doctor

Storage and handling

each tablet contains: calcium 77 mg, salicylate 102 mg store at 15 to 30 0 C (59 to 86 0 F) protect from moisture

Contacts and useful links#

PhoneLabel contact1-(714)-903-7952

Label contents#

Full prescribing information#

Active Ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Bismuth subsalicylate 262mg

Purposes

OTC - PURPOSE SECTION

Anti-diarrheal/ Upset stomach reliever

Uses

INDICATIONS & USAGE SECTION

controls diarrhea
relieves upset stomach due to overindulgence in food or drink

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 symtoms could be an early sign of Reye's syndrome, a rare but serious illness.

Allergy alert: Do not take if you are

allergic to salicylates (including aspirin)
taking other salicylate products

Do not use

OTC - DO NOT USE SECTION

if you have bloody or black stool
if you have an ulcer or 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

OTC - ASK DOCTOR/PHARMACIST SECTION

talking 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.

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

drink plenty of clear fluids to help prevent dehydration caused by diarrhea
repeat dosage every 1/2 to 1 hour as needed
do not take more than 8 doses in 24 hours
use untill diarrhea stops but not more than 2 days
adults and children 12 years and over: 2 tablets
children under 12 years: ask a doctor

Other information

STORAGE AND HANDLING SECTION

each tablet contains: calcium 77 mg, salicylate 102 mg
store at 15 to 30⁰C (59 to 86⁰F)
protect from moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

calcium carbonate, D&C red #27(Al-lake), dextrose, flavor(cherry), magnesium stearate, maltodextrin, silicon dioxide, sorbitol

Questions or comments?

OTC - QUESTIONS SECTION

Adverse drug event call 1-(714)-903-7952

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 66424-045-30

Stomach Relief

Bismuth Subsalicylate 262 mg

Anti-Diarrheal/ Upset Stomach Reliever

Helps to Relieve:

Upset Stomach
Diarrhea
Indigestion
Heartburn
Nausea

†Compare to the Active Ingredients in Pepto-Bismol

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL UNDER CAP IS BROKEN OR MISSING

†This product is not manufactured or distributed by Proctor & Gamble, owner of the registered trademark Pepto-Bismol

Stomach Relief label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
308761	bismuth subsalicylate 262 MG Chewable Tablet	PSN	1
308761	bismuth subsalicylate 262 MG Chewable Tablet	SCD	1

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
BISMUTH CATION Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0be8e4ae-4d57-49f3-b3a9-e4728b4e8d15	Product name	1	20240313
dea2eded-d1e7-46bb-9a3d-f8dc20de6277	Product name	1	20190408
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
66424-045-30	2020-01-31	C162847	48780-1	9d75b9d0-3e5c-f424-e053-dadaa90a57ce	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
66424-045-30	Stomach Relief	30 in 1 BOTTLE, PLASTIC	TABLET, CHEWABLE	30		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
66424-045	STOMACH RELIEF (BISMUTH SUBSALICYLATE) TABLET, CHEWABLE [SDA LABORATORIES, INC.]	1	Legacy NDC, 1 package rows	20130809_c0a08a05-01e4-43a6-a9e8-70accedde2e6.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
BISMUTH SUBSALICYLATE	ACTIVE INGREDIENT	62TEY51RR1	1
BISMUTH CATION	ACTIVE MOIETY	ZS9CD1I8YE	1
CALCIUM CARBONATE	INACTIVE INGREDIENT	H0G9379FGK	1
D&C RED NO. 27	INACTIVE INGREDIENT	2LRS185U6K	1
DEXTROSE	INACTIVE INGREDIENT	IY9XDZ35W2	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	1
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	1

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

Stomach Relief
Bismuth Subsalicylate
BISMUTH CATION
CALCIUM CARBONATE
D&C RED NO. 27
DEXTROSE
MAGNESIUM STEARATE
MALTODEXTRIN
SILICON DIOXIDE
SORBITOL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
66424-045	66424-045-30

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
BISMUTH SUBSALICYLATE	62TEY51RR1	ACTIB
CALCIUM CARBONATE	H0G9379FGK	IACT
D&C RED NO. 27	2LRS185U6K	IACT
DEXTROSE	IY9XDZ35W2	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
MALTODEXTRIN	7CVR7L4A2D	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
SORBITOL	506T60A25R	IACT

Source Document#

Source XML · Source PDF

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 · 187 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	RING / VAGINAL		2 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
MALTODEXTRIN	MALTODEXTRIN	7CVR7L4A2D	GRANULE, FOR SUSPENSION / ORAL		952 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	CREAM, AUGMENTED / TOPICAL	15 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET / SUBLINGUAL	50.5 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
DEXTROSE	DEXTROSE	IY9XDZ35W2	INJECTION / INTRAMUSCULAR	5 %w/v		Exact identifier — unii candidate 21 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	POWDER / ORAL		36000 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
DEXTROSE	DEXTROSE	IY9XDZ35W2	POWDER / VAGINAL	430 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	LIQUID / ORAL		53460 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	AEROSOL, FOAM / TOPICAL	4.95 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
CALCIUM CARBONATE	CALCIUM CARBONATE	H0G9379FGK	TABLET, COATED / ORAL	64.8 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	GUM, CHEWING / ORAL		6168 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
DEXTROSE	DEXTROSE	IY9XDZ35W2	TABLET, CHEWABLE / ORAL		1286 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, COATED / ORAL		3 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
DEXTROSE	DEXTROSE	IY9XDZ35W2	TABLET / ORAL	183.66 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	SOLUTION / ORAL		336 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
D&C RED NO. 27	D&C RED NO. 27	2LRS185U6K	TABLET, EXTENDED RELEASE / ORAL	1.43 mg		Exact identifier — unii candidate 4 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	DROPS / ORAL	NA		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
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CREAM / VAGINAL		51 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TAMPON / VAGINAL	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / VAGINAL	8 %w/w		Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, EXTENDED RELEASE / ORAL		450 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
DEXTROSE	DEXTROSE	IY9XDZ35W2	SPRAY, METERED / NASAL	50 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
DEXTROSE	DEXTROSE	IY9XDZ35W2	SYRUP / ORAL	620 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	OINTMENT / TOPICAL	10 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	FILM, SOLUBLE / ORAL		2 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET / ORAL	337.28 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, EXTENDED RELEASE / ORAL		168 mg	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
SORBITOL	SORBITOL	506T60A25R	TABLET, CHEWABLE / ORAL		3555 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SYRUP / ORAL	4370 mg/5ml		Exact identifier — unii candidate 44 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	GRANULE, FOR SUSPENSION / ORAL		14 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
MALTODEXTRIN	MALTODEXTRIN	7CVR7L4A2D	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 15 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	INJECTION / INTRAVENOUS		1276 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		2 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	INJECTION / INTRALESIONAL	45 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SOLUTION / ORAL		29268 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	POWDER, FOR SUSPENSION / ORAL		12000 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
CALCIUM CARBONATE	CALCIUM CARBONATE	H0G9379FGK	CAPSULE, DELAYED RELEASE / ORAL		20 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	SYSTEM / TRANSDERMAL		35 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	SUSPENSION, EXTENDED RELEASE / ORAL		70 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS	1.04 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
MALTODEXTRIN	MALTODEXTRIN	7CVR7L4A2D	TABLET, CHEWABLE / ORAL	292 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
CALCIUM CARBONATE	CALCIUM CARBONATE	H0G9379FGK	TABLET, EXTENDED RELEASE / ORAL	229.7 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
CALCIUM CARBONATE	CALCIUM CARBONATE	H0G9379FGK	TABLET / ORAL		793 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	LIQUID / TOPICAL	1 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
MALTODEXTRIN	MALTODEXTRIN	7CVR7L4A2D	PASTE / ORAL		1050 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
DEXTROSE	DEXTROSE	IY9XDZ35W2	TABLET, EXTENDED RELEASE / ORAL	103.95 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / NASAL		20 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
MALTODEXTRIN	MALTODEXTRIN	7CVR7L4A2D	TABLET, COATED / ORAL	5.6 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
DEXTROSE	DEXTROSE	IY9XDZ35W2	POWDER, FOR SOLUTION / ORAL	NA		Exact identifier — unii candidate 21 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	POWDER / RESPIRATORY (INHALATION)	0.13 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / SUBLINGUAL		10 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	CONCENTRATE / ORAL	600 mg/1ml		Exact identifier — unii candidate 44 equally ranked IID candidates
DEXTROSE	DEXTROSE	IY9XDZ35W2	SOLUTION / ORAL	2489 mg/5ml		Exact identifier — unii candidate 21 equally ranked IID candidates
MALTODEXTRIN	MALTODEXTRIN	7CVR7L4A2D	TABLET, EFFERVESCENT / ORAL		14404 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	SUSPENSION, EXTENDED RELEASE / ORAL		71 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	GUM, CHEWING / BUCCAL		5110 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	POWDER, FOR SUSPENSION / ORAL		120 mg	Exact identifier — unii candidate 39 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
e00c89cf-22f2-4da7-b3d6-32962dc1de39			c0a08a05-01e4-43a6-a9e8-70accedde2e6	2013-08-03	Warnings	Exact identifier spl id: e00c89cf-22f2-4da7-b3d6-32962dc1de39 spl set id: c0a08a05-01e4-43a6-a9e8-70accedde2e6

Reported adverse events (FAERS/openFDA)#

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