Topcare Stomach Relief

Manufacturer: Topco Associates LLC
Effective date: 2018-02-14
Label type: HUMAN OTC DRUG LABEL
Version: 5
Source: legacy-cache
Hydrated at: 2026-08-02 01:02:55

Label at a glance#

ProductTopcare Stomach Relief

Active ingredientBISMUTH SUBSALICYLATE

Label structure9 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

• shake well before use • only use the dose cup provided • adults and children 12 years and over: 1 dose (30 mL) every hour as needed • do not exceed 4 doses (120 mL) 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 30 mL contains: sodium 12 mg • salicylate 457 mg • low sodium • store at 20-25°C (68-77°F). Avoid excessive heat (over 104°F or (40°C). • protect from freezing • for health information visit www.more-info.info

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-888-423-0139

Websitewww.more-info.info

www.more-info.info

Label contents#

Full prescribing information#

Active ingredient (in each 30 mL)

OTC - ACTIVE INGREDIENT SECTION

Bismuth subsalicylate 1050 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: 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

OTC - DO NOT USE SECTION

if you have

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
diarrhea lasts more than 2 days
ringing in the ears or loss of hearing occurs

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 (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

shake well before use
only use the dose cup provided
adults and children 12 years and over: 1 dose (30 mL) every hour as needed
do not exceed 4 doses (120 mL) 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 30 mL contains: sodium 12 mg
salicylate 457 mg
low sodium
store at 20-25°C (68-77°F). Avoid excessive heat (over 104°F or (40°C).
protect from freezing
for health information visit www.more-info.info

Inactive ingredients

INACTIVE INGREDIENT SECTION

D&C red #22, D&C red #28, glycerin, hydroxyethyl cellulose, methyl salicylate, microcrystalline cellulose and carboxymethylcellulose sodium, purified water, saccharin sodium, salicylic acid, simethicone, sodium salicylate, sorbic acid, xanthan gum

Questions or comments?

OTC - QUESTIONS SECTION

1-888-423-0139

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COMPARE TO PEPTO-BISMOL® MAX STRENGTH ACTIVE INGREDIENT

MAXIMUM STRENGTH

Stomach Relief

BISMUTH SUBSALICYLATE 1050 mg per 30 mL

UPSET STOMACH RELIEVER/ANTIDIARRHEAL

5 SYMPTOM DIGESTIVE RELIEF

Heartburn

Indigestion

Upset Stomach

Nausea

Diarrhea

OUR PHARMACISTS RECOMMEND

8 FL OZ (237 mL)

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
36800-337-34	ML - Milliliter	36800-337	0a50a4e4-6964-41b2-8f6e-429c7a911343	1	2012-07-24
36800-337-40	ML - Milliliter	36800-337	97a904e1-76fd-4bb5-aa42-ef423c8460e1	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
BISMUTH SUBSALICYLATE	ACTIVE INGREDIENT	62TEY51RR1	3
BISMUTH CATION	ACTIVE MOIETY	ZS9CD1I8YE	3
D&C RED NO. 22	INACTIVE INGREDIENT	1678RKX8RT	3
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	3
MAGNESIUM ALUMINUM SILICATE	INACTIVE INGREDIENT	6M3P64V0NC	3
METHYL SALICYLATE	INACTIVE INGREDIENT	LAV5U5022Y	3
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	3
SALICYLIC ACID	INACTIVE INGREDIENT	O414PZ4LPZ	3
SODIUM SALICYLATE	INACTIVE INGREDIENT	WIQ1H85SYP	3
SORBIC ACID	INACTIVE INGREDIENT	X045WJ989B	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	3
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	3

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

Topcare Stomach Relief
Bismuth subsalicylate
SALICYLIC ACID
BISMUTH CATION
D&C RED NO. 22
D&C RED NO. 28
GLYCERIN
METHYL SALICYLATE
CELLULOSE, MICROCRYSTALLINE
CARBOXYMETHYLCELLULOSE SODIUM
WATER
SACCHARIN SODIUM
DIMETHICONE
SILICON DIOXIDE
SODIUM SALICYLATE
SORBIC ACID
XANTHAN GUM

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
36800-337	36800-337-34, 36800-337-40

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
BISMUTH SUBSALICYLATE	62TEY51RR1	ACTIB
D&C RED NO. 22	1678RKX8RT	IACT
D&C RED NO. 28	767IP0Y5NH	IACT
GLYCERIN	PDC6A3C0OX	IACT
METHYL SALICYLATE	LAV5U5022Y	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	IACT
WATER	059QF0KO0R	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT
SALICYLIC ACID	O414PZ4LPZ	IACT
DIMETHICONE	92RU3N3Y1O	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
SODIUM SALICYLATE	WIQ1H85SYP	IACT
SORBIC ACID	X045WJ989B	IACT
XANTHAN GUM	TTV12P4NEE	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 3 · 123 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
SORBIC ACID	SORBIC ACID	X045WJ989B	SOLUTION/ DROPS / OPHTHALMIC	0.2 %w/v		Exact identifier — unii candidate 19 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SOLUTION, GEL FORMING, EXTENDED RELEASE / OPHTHALMIC	0.6 %w/w		Exact identifier — unii candidate 29 equally ranked IID candidates
D&C RED NO. 28	D&C RED NO. 28	767IP0Y5NH	TABLET / ORAL	NA		Exact identifier — unii candidate 11 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	SOLUTION / ORAL		665 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SORBIC ACID	SORBIC ACID	X045WJ989B	GEL / TOPICAL		2 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
METHYL SALICYLATE	METHYL SALICYLATE	LAV5U5022Y	DOUCHE / VAGINAL	0.05 %w/w		Exact identifier — unii candidate 8 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	PASTE / ORAL		1050 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	AEROSOL, FOAM / TOPICAL	0.27 %w/w		Exact identifier — unii candidate 29 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SUSPENSION / ORAL		360 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	FILM / BUCCAL		3 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	TABLET / RECTAL	0.6 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	TROCHE / ORAL		948 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATE	MAGNESIUM ALUMINUM SILICATE	6M3P64V0NC	CONCENTRATE / ORAL	410 mg/5ml		Exact identifier — unii candidate 17 equally ranked IID candidates
METHYL SALICYLATE	METHYL SALICYLATE	LAV5U5022Y	POWDER / TOPICAL	NA		Exact identifier — unii candidate 8 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATE	MAGNESIUM ALUMINUM SILICATE	6M3P64V0NC	TABLET, CHEWABLE / ORAL	12 mg		Exact identifier — unii candidate 17 equally ranked IID candidates
D&C RED NO. 28	D&C RED NO. 28	767IP0Y5NH	CAPSULE, EXTENDED RELEASE / ORAL	0.2 mg		Exact identifier — unii candidate 11 equally ranked IID candidates
SORBIC ACID	SORBIC ACID	X045WJ989B	LOTION / TOPICAL		4 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATE	MAGNESIUM ALUMINUM SILICATE	6M3P64V0NC	CAPSULE / ORAL		60 mg	Exact identifier — unii candidate 17 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		36 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	TABLET, ORALLY DISINTEGRATING / ORAL	0.15 mg		Exact identifier — unii candidate 29 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SUSPENSION / RECTAL		452 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
METHYL SALICYLATE	METHYL SALICYLATE	LAV5U5022Y	CAPSULE / ORAL	16 mg		Exact identifier — unii candidate 8 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	OINTMENT / TOPICAL	NA		Exact identifier — unii candidate 34 equally ranked IID candidates
D&C RED NO. 22	D&C RED NO. 22	1678RKX8RT	SUSPENSION / ORAL	NA		Exact identifier — unii candidate 5 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	ELIXIR / ORAL	15 mg/5ml		Exact identifier — unii candidate 34 equally ranked IID candidates
METHYL SALICYLATE	METHYL SALICYLATE	LAV5U5022Y	PASTE, DENTIFRICE / DENTAL	1.1 %w/w		Exact identifier — unii candidate 8 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	SUSPENSION / RECTAL		290 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
METHYL SALICYLATE	METHYL SALICYLATE	LAV5U5022Y	POWDER, DENTIFRICE / DENTAL	NA		Exact identifier — unii candidate 8 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	SOLUTION / DENTAL	0.05 %w/v		Exact identifier — unii candidate 34 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	GEL / DENTAL	0.3 %w/w		Exact identifier — unii candidate 34 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	TABLET, FILM COATED / ORAL	2 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	POWDER / ORAL	275 mg		Exact identifier — unii candidate 29 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	GRANULE, FOR SUSPENSION / ORAL		450 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	SOLUTION / RECTAL		665 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	POWDER, FOR SUSPENSION / ORAL		600 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
SORBIC ACID	SORBIC ACID	X045WJ989B	TABLET, COATED / ORAL		1 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	SUSPENSION / ORAL	5000 mg/5ml		Exact identifier — unii candidate 34 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATE	MAGNESIUM ALUMINUM SILICATE	6M3P64V0NC	LOTION / TOPICAL	1.5 %w/w		Exact identifier — unii candidate 17 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	TABLET, CHEWABLE / ORAL		84 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
D&C RED NO. 28	D&C RED NO. 28	767IP0Y5NH	SUSPENSION / ORAL	2.5 mg/5ml		Exact identifier — unii candidate 11 equally ranked IID candidates
SORBIC ACID	SORBIC ACID	X045WJ989B	CONCENTRATE / ORAL		1 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	TABLET / SUBLINGUAL		7 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATE	MAGNESIUM ALUMINUM SILICATE	6M3P64V0NC	TABLET, EXTENDED RELEASE / ORAL		70 mg	Exact identifier — unii candidate 17 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATE	MAGNESIUM ALUMINUM SILICATE	6M3P64V0NC	SUSPENSION/ DROPS / ORAL	4.15 mg/2.5ml		Exact identifier — unii candidate 17 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	PASTE / DENTAL	0.3 %w/w		Exact identifier — unii candidate 34 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SUSPENSION / TOPICAL	0.11 %w/v		Exact identifier — unii candidate 29 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	CREAM / TOPICAL		46 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	GEL / TOPICAL		58 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATE	MAGNESIUM ALUMINUM SILICATE	6M3P64V0NC	GRANULE, FOR SUSPENSION / ORAL	12.5 mg/5ml		Exact identifier — unii candidate 17 equally ranked IID candidates
METHYL SALICYLATE	METHYL SALICYLATE	LAV5U5022Y	LOZENGE / ORAL		53 mg	Exact identifier — unii candidate 8 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	WAFER / ORAL	8 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
METHYL SALICYLATE	METHYL SALICYLATE	LAV5U5022Y	GEL / TOPICAL	0.05 %w/w		Exact identifier — unii candidate 8 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SUSPENSION/ DROPS / ORAL		22 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
D&C RED NO. 28	D&C RED NO. 28	767IP0Y5NH	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 11 equally ranked IID candidates
D&C RED NO. 28	D&C RED NO. 28	767IP0Y5NH	POWDER, FOR SOLUTION / ORAL		3 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	TABLET, EXTENDED RELEASE / ORAL		528 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	LIQUID / ORAL		3 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SOLUTION / ORAL		84 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
SORBIC ACID	SORBIC ACID	X045WJ989B	TABLET, DELAYED RELEASE / ORAL	0.03 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	SYRUP / ORAL		24 mg	Exact identifier — unii candidate 34 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
f536f0a6-3e0b-497b-98e5-45367fce225a			4c2f2bfe-759b-43c8-a772-0212e456da1c	2020-04-15	Warnings	Exact identifier spl set id: 4c2f2bfe-759b-43c8-a772-0212e456da1c

Reported adverse events (FAERS/openFDA)#

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