Bismatrol

Manufacturer: Aidarex Pharmaceuticals LLC
Effective date: 2013-12-13
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:38:23

Label at a glance#

ProductBismatrol

Active ingredientBISMUTH SUBSALICYLATE

Label structure9 sections

Indications and uses

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

Dosage and administration

shake well before use for accurate dosing, use dose cup adults and children 12 years and over: 1 dose (2 tbsp or 30 mL) every 1/2 to 1 hour as needed do not exceed 8 doses (16 tbsp or 240 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 Tbsp contains: sodium 5 mg, salicylate 130 mg, potassium 15 mg protect from freezing avoid excessive heat (over 104 o F or 40 o C) TAMPER EVIDENT: Do not use if imprinted shrinkband is missing or broken .

Label contents#

Full prescribing information#

Active ingredient (in each 15 mL tbsp)

OTC - ACTIVE INGREDIENT SECTION

Bismuth subsalicylate 262 mg

Purpose

OTC - PURPOSE SECTION

Upset stomach reliever and anti-diarrheal

Uses

INDICATIONS & USAGE SECTION

relieves:

diarrhea
heartburn
indigestion
nausea
upset stomach associated with these symptoms

Warnings

WARNINGS SECTION

Reye's syndrome: Children and teenagers who have or are recovering from children 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

OTC - ASK DOCTOR/PHARMACIST SECTION

taking any drug for

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

shake well before use
for accurate dosing, use dose cup
adults and children 12 years and over: 1 dose (2 tbsp or 30 mL) every 1/2 to 1 hour as needed
do not exceed 8 doses (16 tbsp or 240 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 Tbsp contains: sodium 5 mg, salicylate 130 mg, potassium 15 mg
protect from freezing
avoid excessive heat (over 104^oF or 40^oC)
TAMPER EVIDENT:Do not use if imprinted shrinkband is missing or broken.

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzoic acid, D and C red 22, D and C red 28, flavor, hydroxy ethyl cellulose, potassium hydroxide, purified water, saccharin sodium, salicylic acid, simethicone, xanthan gum.

Repackaged By :
Aidarex Pharmaceuticals LLC,
Corona, CA 92880

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bismatrol

soothing, coating action provides

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

compare to the active ingredient in pepto-bismol^®

8 FL OZ (236 mL)

KEEP OUT OF REACH OF CHILDREN SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN SECTION.

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
308762	bismuth subsalicylate 525 MG in 30 mL Oral Suspension	PSN	1
308762	bismuth subsalicylate 17.5 MG/ML Oral Suspension	SCD	1
308762	bismuth subsalicylate 1.75 % Oral Suspension	SY	1
308762	bismuth subsalicylate 262 MG per 15 ML Oral Suspension	SY	1
308762	bismuth subsalicylate 524 MG per 30 ML Oral Suspension	SY	1
308762	bismuth subsalicylate 525 MG per 30 ML Oral Suspension	SY	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
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
dea2eded-d1e7-46bb-9a3d-f8dc20de6277	Product name	1	20190408
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53217-060-01	2020-01-31	C162847	48780-1	9d75b9d1-2544-f424-e053-dadaa90a57ce	Bismatrol

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53217-060-01	Bismatrol	236 mL in 1 BOTTLE, PLASTIC	LIQUID	236		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53217-060	BISMATROL (BISMUTH SUBSALICYLATE) LIQUID [AIDAREX PHARMACEUTICALS LLC]	1	Legacy NDC, 1 package rows	20140214_6b4d6e96-4d67-43cd-b4ff-8d02e80e0b3c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
53217-060-01	ML - Milliliter	53217-060	9928f783-a993-40ff-8da2-475112c0c3cb	1	2015-10-02
0904-1313-09	ML - Milliliter	0904-1313	56076192-e0b3-49bb-ba2d-88b6f259e9c2	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
BISMUTH SUBSALICYLATE	ACTIVE INGREDIENT	62TEY51RR1	1
BISMUTH CATION	ACTIVE MOIETY	ZS9CD1I8YE	1
BENZOIC ACID	INACTIVE INGREDIENT	8SKN0B0MIM	1
D&C RED NO. 22	INACTIVE INGREDIENT	1678RKX8RT	1
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	1
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	1
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)	INACTIVE INGREDIENT	S38J6RZN16	1
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	1
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	1
SALICYLIC ACID	INACTIVE INGREDIENT	O414PZ4LPZ	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	1

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

Bismatrol
Bismuth Subsalicylate
BISMUTH CATION
BENZOIC ACID
D&C RED NO. 22
D&C RED NO. 28
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)
POTASSIUM HYDROXIDE
WATER
SACCHARIN SODIUM
SALICYLIC ACID
DIMETHICONE
XANTHAN GUM

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
53217-060	53217-060-01
0904-1313

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
BISMUTH SUBSALICYLATE	62TEY51RR1	ACTIB
BENZOIC ACID	8SKN0B0MIM	IACT
D&C RED NO. 22	1678RKX8RT	IACT
D&C RED NO. 28	767IP0Y5NH	IACT
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)	S38J6RZN16	IACT
POTASSIUM HYDROXIDE	WZH3C48M4T	IACT
WATER	059QF0KO0R	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT
SALICYLIC ACID	O414PZ4LPZ	IACT
DIMETHICONE	92RU3N3Y1O	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 · 130 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	SUSPENSION / RECTAL	0.1 %w/w		Exact identifier — unii candidate 23 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	CONCENTRATE / ORAL		6 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	FILM, SOLUBLE / ORAL		1 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	TABLET / ORAL		43 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	PASTE / ORAL		3 mg	Exact identifier — unii candidate 34 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
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)	HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)	S38J6RZN16	GEL / TOPICAL		4 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	LOZENGE / ORAL		1264 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
D&C RED NO. 22	D&C RED NO. 22	1678RKX8RT	TABLET, COATED / ORAL	NA		Exact identifier — unii candidate 5 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	TABLET / SUBLINGUAL		7 mg	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
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SUSPENSION/ DROPS / ORAL		22 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SUSPENSION / TOPICAL	0.11 %w/v		Exact identifier — unii candidate 29 equally ranked IID candidates
D&C RED NO. 22	D&C RED NO. 22	1678RKX8RT	CAPSULE / ORAL	0.02 mg		Exact identifier — unii candidate 5 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	LIQUID / ORAL		3 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
D&C RED NO. 28	D&C RED NO. 28	767IP0Y5NH	SOAP / TOPICAL	NA		Exact identifier — unii candidate 11 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	TABLET, ORALLY DISINTEGRATING / ORAL		10 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	OINTMENT / DENTAL	NA		Exact identifier — unii candidate 34 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	MOUTHWASH / BUCCAL	NA		Exact identifier — unii candidate 23 equally ranked IID candidates
POTASSIUM HYDROXIDE	POTASSIUM HYDROXIDE	WZH3C48M4T	CAPSULE, EXTENDED RELEASE / ORAL	0.07 mg		Exact identifier — unii candidate 13 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)	HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)	S38J6RZN16	SOLUTION / TOPICAL	0.21 %w/v		Exact identifier — unii candidate 15 equally ranked IID candidates
D&C RED NO. 28	D&C RED NO. 28	767IP0Y5NH	CAPSULE, COATED PELLETS / ORAL	NA		Exact identifier — unii candidate 11 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	POWDER / ORAL	275 mg		Exact identifier — unii candidate 29 equally ranked IID candidates
POTASSIUM HYDROXIDE	POTASSIUM HYDROXIDE	WZH3C48M4T	SOLUTION / TOPICAL	14.02 %w/w		Exact identifier — unii candidate 13 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	POWDER, FOR SUSPENSION / ORAL		600 mg	Exact identifier — unii candidate 29 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
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	SOLUTION / RECTAL		665 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)	HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)	S38J6RZN16	SOLUTION / ORAL		3 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	ENEMA / RECTAL		150 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
D&C RED NO. 28	D&C RED NO. 28	767IP0Y5NH	CAPSULE, DELAYED RELEASE / ORAL		1 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	TABLET / RECTAL	0.6 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
D&C RED NO. 22	D&C RED NO. 22	1678RKX8RT	TABLET, DELAYED RELEASE / ORAL	0.38 mg		Exact identifier — unii candidate 5 equally ranked IID candidates
POTASSIUM HYDROXIDE	POTASSIUM HYDROXIDE	WZH3C48M4T	INJECTION / INTRAVENOUS	ADJ PH		Exact identifier — unii candidate 13 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	GRANULE, FOR SOLUTION / ORAL	5.5 mg/120ml		Exact identifier — unii candidate 34 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	SOLUTION / ORAL		100 mg	Exact identifier — unii candidate 23 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	CONCENTRATE / ORAL	12.5 mg/5ml		Exact identifier — unii candidate 23 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)	HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)	S38J6RZN16	SUSPENSION / ORAL		100 mg	Exact identifier — unii candidate 15 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
POTASSIUM HYDROXIDE	POTASSIUM HYDROXIDE	WZH3C48M4T	PASTILLE / ORAL	ADJ PH		Exact identifier — unii candidate 13 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SUSPENSION / ORAL		360 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	POWDER, FOR SOLUTION / ORAL	10 mg/5ml		Exact identifier — unii candidate 29 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
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	GEL / TOPICAL		58 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
POTASSIUM HYDROXIDE	POTASSIUM HYDROXIDE	WZH3C48M4T	CAPSULE / ORAL		172 mg	Exact identifier — unii candidate 13 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)	HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)	S38J6RZN16	TABLET, CHEWABLE / ORAL	5.9 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
D&C RED NO. 28	D&C RED NO. 28	767IP0Y5NH	AEROSOL / TOPICAL	NA		Exact identifier — unii candidate 11 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	TABLET, FILM COATED / ORAL	NA		Exact identifier — unii candidate 23 equally ranked IID candidates
POTASSIUM HYDROXIDE	POTASSIUM HYDROXIDE	WZH3C48M4T	AEROSOL, FOAM / TOPICAL	ADJ PH		Exact identifier — unii candidate 13 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
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)	HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)	S38J6RZN16	SYRUP / ORAL	2 mg/5ml		Exact identifier — unii candidate 15 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	SOLUTION / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 23 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	SUPPOSITORY / VAGINAL	2 mg		Exact identifier — unii candidate 23 equally ranked IID candidates
POTASSIUM HYDROXIDE	POTASSIUM HYDROXIDE	WZH3C48M4T	CREAM / TOPICAL	0.5 %w/w		Exact identifier — unii candidate 13 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	ELIXIR / ORAL	15 mg/5ml		Exact identifier — unii candidate 34 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	CREAM / TOPICAL		46 mg	Exact identifier — unii candidate 29 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

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
55591708-1dc9-45bb-8870-12609d4b51c7			6b4d6e96-4d67-43cd-b4ff-8d02e80e0b3c	2013-12-13	Warnings	Exact identifier spl id: 55591708-1dc9-45bb-8870-12609d4b51c7 spl set id: 6b4d6e96-4d67-43cd-b4ff-8d02e80e0b3c

Reported adverse events (FAERS/openFDA)#

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