FDA.reportPublic FDA data

Major Bismatrol Chewable Tablets

Manufacturer
Preferred Pharmaceuticals Inc.
Effective date
2023-04-06
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 21:33:23

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

• 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 caused by diarrhea.

Storage and handling

each tablet contains: • sodium less than 1 mg • salicylate 102 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.

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 taking any drug for

OTC - ASK DOCTOR/PHARMACIST SECTION

  • 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.

Keep Out of Reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN 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 caused by diarrhea.

Other information:

STORAGE AND HANDLING SECTION

each tablet contains:

  • sodium less than 1 mg
  • salicylate 102 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&C red 27 aluminum lake, flavor, magnesium stearate, mannitol, pregelatinized starch, saccharin sodium.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MAJOR

NDC 68788-7140-3

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®

Relabeled By: Preferred Pharmaceuticals Inc.

30 chewable tablets

Bismatrol Chewable Tablets
Bismatrol Chewable Tablets

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7140-3EA - Each68788-71409e360f3a-7f30-4644-8404-5dd02830574112018-06-11
0904-1315-46EA - Each0904-13152b54e32c-200b-45ca-93e6-9d2ab9e2321c12013-02-13

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68788-714068788-7140-3
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
NameUNIIKind
BISMUTH SUBSALICYLATE62TEY51RR1ACTIB
CALCIUM CARBONATEH0G9379FGKIACT
D&C RED NO. 272LRS185U6KIACT
MAGNESIUM STEARATE70097M6I30IACT
MANNITOL3OWL53L36AIACT
STARCH, CORNO8232NY3SJIACT
SACCHARIN SODIUMSB8ZUX40TYIACT

Source Document#

Source XML

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
49e3c9c1-9bb3-4d9b-8bc3-08b64d73df6ae1d5e365-5dc8-4d77-a730-f59eeb8fb01a2024-03-11WarningsExact identifier
spl set id: e1d5e365-5dc8-4d77-a730-f59eeb8fb01a

Reported adverse events (FAERS/openFDA)#

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