FDA.reportPublic FDA data

Leader Stomach Relief

Manufacturer
CARDINAL HEALTH 110, LLC. DBA LEADER
Effective date
2022-01-10
Label type
Human OTC Drug Label
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:18:41

Label at a glance#

ProductLeader Stomach Relief
Active ingredientBISMUTH SUBSALICYLATE
Label structure15 sections

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 use until diarrhea stops but not more than 2 days children under 12 years: ask a doctor drink plenty of fluids to help prevent dehydration which may accompany diarrhea

Storage and handling

each tablet contains: sodium less than 1 mg salicylate 102 mg very low sodium avoid excessive heat (over 104 o F or 40 o C) TAMPER EVIDENT: Do not use if individual compartments are torn or open

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

USE(S)

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 behaviour 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 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,

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.

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
  • use until diarrhea stops but not more than 2 days
  • children under 12 years: ask a doctor
  • drink plenty of fluids to help prevent dehydration which may accompany 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 104oF or 40oC)
  • TAMPER EVIDENT: Do not use if individual compartments are torn or open

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

NDC 70000-0433-2
LEADER™

Stomach Relief
Bismuth Subsalicylate 262 mg
Upset Stomach Reliever/Antidiarrheal

5 Symptom Digestive Relief

  • Diarrhea
  • Heartburn
  • Indigestion
  • Nausea
  • Upset stomach

COMPATE TO PEPTO-BISMOL® active ingredient*

48 CHEWABLE TABLETS



52
52

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70000-0433-12025-08-22C16284748780-11030e365-6d0f-111a-e063-dadaa90a10e2Leader Stomach Relief
70000-0433-22025-08-22C16284748780-11030e365-6d0f-111a-e063-dadaa90a10e2Leader Stomach Relief
70000-0433-12024-01-30C16284748780-11030e365-6d0f-111a-e063-dadaa90a10e2Leader Stomach Relief
70000-0433-22024-01-30C16284748780-11030e365-6d0f-111a-e063-dadaa90a10e2Leader Stomach Relief

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0433LEADER STOMACH RELIEF (BISMUTH SUBSALICYLATE) TABLET, CHEWABLE [CARDINAL HEALTH 110, LLC. DBA LEADER]3Legacy NDC20220111_91fbcda6-a068-4ed0-9502-caf395580ad9.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0433-1EA - Each70000-04336f59121a-3d47-4bca-8fd4-7dbf1417f73512020-02-13
70000-0433-2EA - Each70000-0433f406ffd7-47eb-4d06-a80f-b1676d63497e12020-03-10

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
70000-043370000-0433-2, 70000-0433-1

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
dc2f18e0-3c52-4215-8e94-46ab3a2a801991fbcda6-a068-4ed0-9502-caf395580ad92025-08-21WarningsExact identifier
spl set id: 91fbcda6-a068-4ed0-9502-caf395580ad9

Reported adverse events (FAERS/openFDA)#

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