Major Bismatrol Chewable Tablets

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 22:38:22

Label at a glance#

ProductBismatrol

Active ingredientBISMUTH SUBSALICYLATE

Label structure7 sections

Indications and uses

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

Dosage and administration

chew or dissolve in mouth adults and children 12 years and over: 2 tablets every 1/2 to 1 hour as needed do not take more than 8 doses (16 tablets) in 24 hours children under 12 years: ask a doctor drink plenty of fluids to help prevent dehydration which may accompany diarrhea. Other information: each tablet contains: sodium less than 1 mg salicylate 102 mg calcium 140 mg very low sodium avoid excessive heat (over...

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Bismuth subsalicylate 262 mg

(total salicylate 102 mg per tablet)

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 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 stools
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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

chew or dissolve in mouth
adults and children 12 years and over: 2 tablets every 1/2 to 1 hour as needed
do not take more than 8 doses (16 tablets) in 24 hours
children under 12 years: ask a doctor
drink plenty of fluids to help prevent dehydration which may accompany diarrhea.

Other information: each tablet contains:

sodium less than 1 mg
salicylate 102 mg
calcium 140 mg
very low sodium
avoid excessive heat (over 104˚F or 40˚C)
TAMPER EVIDENT: Do not use if individual compartments are torn or missing.

Inactive ingredients

INACTIVE INGREDIENT SECTION

calcium carbonate, D and C red 27 aluminum lake, flavor, magnesium stearate, mannitol, pregelatinized starch, saccharin sodium.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bismatrol Chewable Tablets

soothing, coating action provides fast relief for heartburn, indigestion, nausea, upset stomach and diarrhea

compare to the active ingredient in Pepto-Bismol^®

30 chewable tablets

Repackaged By :
Aidarex Pharmaceuticals LLC,
Corona, CA 92880

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
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
dea2eded-d1e7-46bb-9a3d-f8dc20de6277	Product name	1	20190408
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53217-058-01	2020-01-31	C162847	48780-1	9d75b9d0-a2d0-f424-e053-dadaa90a57ce	Major Bismatrol Chewable Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53217-058-01	Bismatrol	30 in 1 BLISTER PACK	TABLET, CHEWABLE	30		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53217-058	BISMATROL (BISMUTH SUBSALICYLATE) TABLET, CHEWABLE [AIDAREX PHARMACEUTICALS LLC]	1	Legacy NDC, 1 package rows	20140214_4706704a-d970-48b8-89d4-c73a8fb761ca.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
53217-058-01	EA - Each	53217-058	3174e246-2a9a-4d11-993c-9f6bcf009a4d	1	2015-12-02
0904-1315-46	EA - Each	0904-1315	2b54e32c-200b-45ca-93e6-9d2ab9e2321c	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
CALCIUM CARBONATE	INACTIVE INGREDIENT	H0G9379FGK	1
D&C RED NO. 27	INACTIVE INGREDIENT	2LRS185U6K	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	1
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	1
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	1

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

Bismatrol
Bismuth subsalicylate
BISMUTH CATION
CALCIUM CARBONATE
D&C RED NO. 27
MAGNESIUM STEARATE
MANNITOL
STARCH, CORN
SACCHARIN SODIUM

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
53217-058	53217-058-01
0904-1315

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
BISMUTH SUBSALICYLATE	62TEY51RR1	ACTIB
CALCIUM CARBONATE	H0G9379FGK	IACT
D&C RED NO. 27	2LRS185U6K	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
MANNITOL	3OWL53L36A	IACT
STARCH, CORN	O8232NY3SJ	IACT
SACCHARIN SODIUM	SB8ZUX40TY	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 · 179 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
MANNITOL	MANNITOL	3OWL53L36A	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	300 mg		Exact identifier — unii candidate 65 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	INJECTION, SOLUTION / SUBCUTANEOUS		99 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	980.4 mg		Exact identifier — unii candidate 65 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	INJECTION / INTRAMUSCULAR		22 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	CAPSULE, EXTENDED RELEASE / ORAL		160 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	SOLUTION / ORAL		869 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	TABLET / RECTAL	0.6 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	SOLUTION / DENTAL	0.05 %w/v		Exact identifier — unii candidate 34 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR		113 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	CAPSULE, EXTENDED RELEASE / ORAL		194 mg	Exact identifier — unii candidate 22 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
MANNITOL	MANNITOL	3OWL53L36A	INJECTION, POWDER, FOR SOLUTION / PARENTERAL	200 mg		Exact identifier — unii candidate 65 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	GRANULE / ORAL		629 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / SUBLINGUAL	17.5 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	SUSPENSION/ DROPS / ORAL		90 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	POWDER / RESPIRATORY (INHALATION)		6 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, CHEWABLE / ORAL		127 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	SUSPENSION, EXTENDED RELEASE / ORAL	2464.6 mg		Exact identifier — unii candidate 65 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	TABLET, CHEWABLE / ORAL		3726 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
CALCIUM CARBONATE	CALCIUM CARBONATE	H0G9379FGK	SOLUTION / RESPIRATORY (INHALATION)	4.02 %w/v		Exact identifier — unii candidate 15 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET, ORALLY DISINTEGRATING / ORAL		100 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	POWDER, FOR SUSPENSION / ORAL		34 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	SOLUTION, CONCENTRATE / INTRAVENOUS		220 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / BUCCAL	17.5 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	SOLUTION / SUBCUTANEOUS	4.54 %w/v		Exact identifier — unii candidate 65 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	TABLET / BUCCAL		360 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	SYSTEM / INTRAVITREAL	0.02 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	IMPLANT / INTRAVITREAL	NA		Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	POWDER / TOPICAL		104 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		543 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		53 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	TABLET / ORAL		43 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	INJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		105 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	SUSPENSION / RECTAL		290 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	CAPSULE, DELAYED RELEASE / ORAL		2043 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	PASTE / DENTAL	0.3 %w/w		Exact identifier — unii candidate 34 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	TABLET, DELAYED RELEASE / ORAL		639 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 39 equally ranked IID candidates
CALCIUM CARBONATE	CALCIUM CARBONATE	H0G9379FGK	TABLET, DELAYED RELEASE / ORAL	8.4 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	POWDER, FOR SUSPENSION / INTRAMUSCULAR	6.75 %w/v		Exact identifier — unii candidate 65 equally ranked IID candidates
CALCIUM CARBONATE	CALCIUM CARBONATE	H0G9379FGK	GUM, CHEWING / BUCCAL		3492 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, DELAYED RELEASE / ORAL		144 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	CAPSULE, COATED, EXTENDED RELEASE / ORAL		19 mg	Exact identifier — unii candidate 22 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
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	PASTE / ORAL		3 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	SPRAY / NASAL	41.5 mg		Exact identifier — unii candidate 65 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	CONCENTRATE / ORAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	INJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS	35 mg		Exact identifier — unii candidate 65 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	CAPSULE / ORAL		1562 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	CAPSULE, COATED PELLETS / ORAL		14 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	POWDER / ORAL		4352 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL		980 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	SOLUTION / RECTAL		665 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	CREAM / TOPICAL	NA		Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, FILM COATED / ORAL		96 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	LIQUID / ORAL		3 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	CONCENTRATE / INTRAVENOUS		220 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	SOLUTION / INTRAVENOUS		15400 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	TABLET / BUCCAL	0.4 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
CALCIUM CARBONATE	CALCIUM CARBONATE	H0G9379FGK	CAPSULE, EXTENDED RELEASE / ORAL	4 mg		Exact identifier — unii candidate 15 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
c5eb25f0-c650-4cc7-8f2c-60574e93c8fc			4706704a-d970-48b8-89d4-c73a8fb761ca	2013-12-13	Warnings	Exact identifier spl id: c5eb25f0-c650-4cc7-8f2c-60574e93c8fc spl set id: 4706704a-d970-48b8-89d4-c73a8fb761ca

Reported adverse events (FAERS/openFDA)#

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