Bismutina

Manufacturer: Menper Distributors, Inc.
Effective date: 2020-02-03
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: legacy-cache
Hydrated at: 2026-08-01 23:41:40

Label at a glance#

ProductBismutina

Active ingredientBISMUTH SUBSALICYLATE

Label structure16 sections

Indications and uses

Relieves: Diarrhea Upset stomach due to over indulgence in food and drink, including : Heartburn Indigestion Nausea gas belching

Dosage and administration

shake well before use for accurate dosing use dose cup adults and children 12 years of age and over: 1 dose (2 tbsp or 30 mL) every 1/2 hours to 1 hour as needed no not exceed 8 doses (16 Tbsp or 240 mL) in 24 hours Use until diarrhea stops, but no more than 2 days. Children under 12 years: consult a doctor drink prenty of water or clear fluids to help prevent dehydration cause by diarrhea

Contacts and useful links#

PhoneLabel contact1-800-560-5223

Label contents#

Full prescribing information#

Active Ingredient(in each 15 mL tablespoon)

OTC - ACTIVE INGREDIENT SECTION

Bismuth Subsalycilate 262 mg..................................... Upset Stomag reliever and antidiarrheal

Purpose

OTC - PURPOSE SECTION

upset stomach reliever and antidiarrheal

Uses

INDICATIONS & USAGE SECTION

Relieves:

Diarrhea
Upset stomach due to over indulgence in food and drink, including :
Heartburn
Indigestion
Nausea
gas
belching

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 or vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

OTC - DO NOT USE SECTION

Allergy Alert: Contains salicylate. Do not take if you are:

Allergic to salicilates (including aspirin)
Taking other salicylate products

Do not use 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 doctor or pharmacist before use if you are taking any drugs for

OTC - ASK DOCTOR/PHARMACIST SECTION

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
diarreah 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 the reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

in case of accidental overdose. get medical help or contact a Poison Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

shake well before use
for accurate dosing use dose cup
adults and children 12 years of age and over: 1 dose (2 tbsp or 30 mL) every 1/2 hours to 1 hour as needed
no not exceed 8 doses (16 Tbsp or 240 mL) in 24 hours
Use until diarrhea stops, but no more than 2 days.
Children under 12 years: consult a doctor
drink prenty of water or clear fluids to help prevent dehydration cause by diarrhea

Other safety information

OTHER SAFETY INFORMATION

Low sodium
Sugar free
Salicylate 130 mg
Protect from freezing
Avoid excessive heat (more tha 104° F or 40° C)
Tamper-Evident: Do not use if printed cello-band is torn, broken or missing.

inactive ingredients

INACTIVE INGREDIENT SECTION

benzoic acid, FD&C yellow #5, flavor, kaolin, magnesium aluminium silicate,salicylic acid, sodium saccharin, sodium salicylate, sorbic acid, sucralose, sucrose, water, xanthan gum

Questions?

OTC - QUESTIONS SECTION

call 1-800-560-5223 M-F 9 AM to 5 PM Eastern Time

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BISMUTINA

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53145-055-08	2020-02-07	C162847	48780-1	9d75b9d0-db79-f424-e053-dadaa90a57ce	0c793691-4388-40f1-8f61-fb1ca36096f6
53145-055-08	2020-01-31	C162847	48780-1	9d75b9d0-db79-f424-e053-dadaa90a57ce	0c793691-4388-40f1-8f61-fb1ca36096f6

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
BISMUTH SUBSALICYLATE	ACTIVE INGREDIENT	62TEY51RR1	2
SALICYLIC ACID	ACTIVE MOIETY	O414PZ4LPZ	2
BENZOIC ACID	INACTIVE INGREDIENT	8SKN0B0MIM	2
FD&C YELLOW NO. 5	INACTIVE INGREDIENT	I753WB2F1M	2
KAOLIN	INACTIVE INGREDIENT	24H4NWX5CO	2
MAGNESIUM ALUMINUM SILICATE	INACTIVE INGREDIENT	6M3P64V0NC	2
SALICYLIC ACID	INACTIVE INGREDIENT	O414PZ4LPZ	2
SODIUM SALICYLATE	INACTIVE INGREDIENT	WIQ1H85SYP	2
SORBIC ACID	INACTIVE INGREDIENT	X045WJ989B	2
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	2
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	2

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

Bismutina
Bismuth Subsalycilate
BISMUTH SUBSALICYLATE
SALICYLIC ACID
BENZOIC ACID
FD&C YELLOW NO. 5
KAOLIN
MAGNESIUM ALUMINUM SILICATE
SACCHARIN SODIUM
SODIUM SALICYLATE
SORBIC ACID
SUCRALOSE
SUCROSE
WATER
XANTHAN GUM

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
53145-055	53145-055-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
BISMUTH SUBSALICYLATE	62TEY51RR1	ACTIB
BENZOIC ACID	8SKN0B0MIM	IACT
FD&C YELLOW NO. 5	I753WB2F1M	IACT
KAOLIN	24H4NWX5CO	IACT
MAGNESIUM ALUMINUM SILICATE	6M3P64V0NC	IACT
SALICYLIC ACID	O414PZ4LPZ	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT
SODIUM SALICYLATE	WIQ1H85SYP	IACT
SORBIC ACID	X045WJ989B	IACT
SUCRALOSE	96K6UQ3ZD4	IACT
SUCROSE	C151H8M554	IACT
WATER	059QF0KO0R	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 · 145 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	CAPSULE / ORAL	652 mg		Exact identifier — unii candidate 22 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
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	PASTE / ORAL		1050 mg	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
MAGNESIUM ALUMINUM SILICATE	MAGNESIUM ALUMINUM SILICATE	6M3P64V0NC	SUSPENSION / RECTAL		14480 mg	Exact identifier — unii candidate 17 equally ranked IID candidates
SORBIC ACID	SORBIC ACID	X045WJ989B	OINTMENT / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 19 equally ranked IID candidates
SORBIC ACID	SORBIC ACID	X045WJ989B	TABLET, COATED / ORAL		1 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	POWDER, FOR SUSPENSION / ORAL		600 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
KAOLIN	KAOLIN	24H4NWX5CO	CAPSULE, COATED PELLETS / ORAL		234 mg	Exact identifier — unii candidate 13 equally ranked IID candidates
KAOLIN	KAOLIN	24H4NWX5CO	SYRUP / ORAL	10 mg/1ml		Exact identifier — unii candidate 13 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATE	MAGNESIUM ALUMINUM SILICATE	6M3P64V0NC	POWDER, FOR SUSPENSION / ORAL	NA		Exact identifier — unii candidate 17 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	CREAM / VAGINAL		10 mg	Exact identifier — unii candidate 23 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	TABLET / SUBLINGUAL	0.11 mg		Exact identifier — unii candidate 22 equally ranked IID candidates
KAOLIN	KAOLIN	24H4NWX5CO	TABLET, EXTENDED RELEASE / ORAL	66 mg		Exact identifier — unii candidate 13 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	TABLET, EXTENDED RELEASE / ORAL		528 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	TABLET, DELAYED RELEASE / ORAL		3 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	TABLET, FILM COATED / ORAL	0.08 mg		Exact identifier — unii candidate 29 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SUSPENSION, EXTENDED RELEASE / ORAL	186.8 mg		Exact identifier — unii candidate 29 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	SOLUTION / ORAL		800 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	SOLUTION / ORAL	1 mg/1ml		Exact identifier — unii candidate 22 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	ENEMA / RECTAL		150 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
SORBIC ACID	SORBIC ACID	X045WJ989B	EMULSION / OPHTHALMIC		1 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
KAOLIN	KAOLIN	24H4NWX5CO	POWDER, FOR SUSPENSION / ORAL	NA		Exact identifier — unii candidate 13 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	AEROSOL, FOAM / VAGINAL	0.1 %w/w		Exact identifier — unii candidate 23 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	FILM, SOLUBLE / ORAL		1 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	AEROSOL, FOAM / TOPICAL		1 mg	Exact identifier — unii candidate 23 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATE	MAGNESIUM ALUMINUM SILICATE	6M3P64V0NC	OINTMENT / VAGINAL		231 mg	Exact identifier — unii candidate 17 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	LIQUID / ORAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	GRANULE, FOR SUSPENSION / ORAL		450 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
KAOLIN	KAOLIN	24H4NWX5CO	TABLET, COATED / ORAL	52.44 mg		Exact identifier — unii candidate 13 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SUSPENSION / OPHTHALMIC		2 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	ELIXIR / ORAL		90 mg	Exact identifier — unii candidate 23 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	INJECTION, SOLUTION / INTRAMUSCULAR	0.2 %w/v		Exact identifier — unii candidate 23 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	SOLUTION / IRRIGATION	0.02 %w/v		Exact identifier — unii candidate 23 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATE	MAGNESIUM ALUMINUM SILICATE	6M3P64V0NC	CAPSULE / ORAL		60 mg	Exact identifier — unii candidate 17 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	SYRUP / ORAL		20 mg	Exact identifier — unii candidate 23 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	TABLET / ORAL		45 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	TABLET, FOR SUSPENSION / ORAL		65 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	TABLET / ORAL		56 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	CONCENTRATE / ORAL	12.5 mg/5ml		Exact identifier — unii candidate 23 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	LOZENGE / ORAL		115 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SUSPENSION/ DROPS / ORAL		22 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
SORBIC ACID	SORBIC ACID	X045WJ989B	GEL / TOPICAL		2 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	GEL / TOPICAL		58 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	LOZENGE / ORAL		1264 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	LOTION / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 23 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	SYRUP / ORAL	0.1 mg		Exact identifier — unii candidate 22 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	GEL / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 23 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
KAOLIN	KAOLIN	24H4NWX5CO	POWDER / TOPICAL		10056 mg	Exact identifier — unii candidate 13 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATE	MAGNESIUM ALUMINUM SILICATE	6M3P64V0NC	SYRUP / ORAL	100 mg/1ml		Exact identifier — unii candidate 17 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	LIQUID / ORAL	2 mg/1ml		Exact identifier — unii candidate 23 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	SOLUTION / TOPICAL	0.06 %w/w		Exact identifier — unii candidate 22 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	LOZENGE / BUCCAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	MOUTHWASH / BUCCAL	NA		Exact identifier — unii candidate 23 equally ranked IID candidates
KAOLIN	KAOLIN	24H4NWX5CO	TABLET / ORAL	150 mg		Exact identifier — unii candidate 13 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	TABLET, FILM COATED / ORAL	NA		Exact identifier — unii candidate 23 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	TABLET, FILM COATED / ORAL	1.68 mg		Exact identifier — unii candidate 22 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATE	MAGNESIUM ALUMINUM SILICATE	6M3P64V0NC	PASTE, DENTIFRICE / DENTAL	0.4 %w/w		Exact identifier — unii candidate 17 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
fd5c8571-c34c-4ff6-aa2f-4e960851ec69			0c793691-4388-40f1-8f61-fb1ca36096f6	2020-04-18	Warnings	Exact identifier spl set id: 0c793691-4388-40f1-8f61-fb1ca36096f6

Reported adverse events (FAERS/openFDA)#

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