FDA.reportPublic FDA data

Leader Stomach Relief

Manufacturer
Cardinal Health
Effective date
2021-01-22
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 22:55:27

Label at a glance#

ProductLeader Stomach Relief original strength
Active ingredientBISMUTH SUBSALICYLATE
Label structure9 sections

Indications and uses

relieves ▪ travelers’ diarrhea ▪ diarrhea ▪ upset stomach due to overindulgence in food and drink, including: ▪ heartburn ▪ indigestion ▪ nausea ▪ gas ▪ fullness

Dosage and administration

▪ chew or dissolve tablets in mouth ▪ drink plenty of clear fluids to help prevent dehydration caused by diarrhea ▪ adults and children 12 years and older: 2 tablets every ½ to 1 hour, or 4 tablets every hour as needed ▪ do not exceed 16 tablets in 24 hours ▪ use until diarrhea stops but not more than 2 days ▪ children under 12 years: ask a doctor

Storage and handling

▪ each tablet contains: salicylate 102 mg ▪ Do not use if individual blister compartments are torn or open ▪ Store at room temperature 59°-86°F

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Bismuth subsalicylate 262 mg

Purpose

OTC - PURPOSE SECTION

Antidiarrheal/upset stomach reliever

(total salicylate 102 mg per tablet)

Uses

INDICATIONS & USAGE SECTION

relieves

  • travelers’ diarrhea
  • diarrhea
  • upset stomach due to overindulgence in food and drink, including:
  • heartburn
  • indigestion
  • nausea
  • gas
  • fullness

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 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 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,

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 tablets in mouth
  • drink plenty of clear fluids to help prevent dehydration caused by diarrhea
  • adults and children 12 years and older: 2 tablets every ½ to 1 hour, or 4 tablets every hour as needed
  • do not exceed 16 tablets in 24 hours
  • use until diarrhea stops but not more than 2 days
  • children under 12 years: ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • each tablet contains: salicylate 102 mg
  • Do not use if individual blister compartments are torn or open
  • Store at room temperature 59°-86°F

Inactive ingredients

INACTIVE INGREDIENT SECTION

flavor, magnesium stearate, microcrystalline cellulose, red #27 aluminum lake, sorbitol, sucralose

Questions?

OTC - QUESTIONS SECTION

1-800-719-9260

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LEADER

NDC 37205-720-65

Compare to Pepto-Bismol® active ingredient*

Pink Bismuth

Chewable Tablets

Bismuth Subsalicylate 262 mg

Original Flavor

Provides Soothing Relief for:

  • Indigestion
  • Upset Stomach
  • Nausea
  • Diarrhea
  • Heartburn

SATISFACTION GUARANTEED

30 CHEWABLE TABLETS

All Leader® Brand products are 100% satisfaction guaranteed or return to place of purchase for a full refund.

Distributed By: Cardinal Health

Dublin, Ohio 43017

www.myleader.com

CIN 2572691

*This product is not manufactured or distributed by Procter & Gamble Inc., the distributor of PEPTO-BISMOL®.

Stomach Relief Chewables Carton
Stomach Relief Chewables Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
37205-720-652025-04-24C16284748780-1f386c64a-0c75-0266-e053-dadaa90a7c1aCardinal Health Stomach Relief Chewables Drug Facts
37205-720-652023-01-30C16284748780-1f386c64a-0c75-0266-e053-dadaa90a7c1aCardinal Health Stomach Relief Chewables Drug Facts

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
37205-720-65EA - Each37205-72067651802-d74e-4876-83d8-ddad5ab7084712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BISMUTH SUBSALICYLATEACTIVE INGREDIENT62TEY51RR12
BISMUTH SUBSALICYLATEACTIVE MOIETY62TEY51RR12
CALCIUM CARBONATEINACTIVE INGREDIENTH0G9379FGK2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I302
MANNITOLINACTIVE INGREDIENT3OWL53L36A2
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TY2

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
37205-72037205-720-65

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
BISMUTH SUBSALICYLATE62TEY51RR1ACTIB
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
D&C RED NO. 272LRS185U6KIACT
SORBITOL506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT

Source Document#

Source XML · Source PDF

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 · 153 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, CHEWABLE / ORAL127 mgExact identifier — unii candidate
39 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKTABLET, EXTENDED RELEASE / ORAL229.7 mgExact identifier — unii candidate
15 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKTABLET / ORAL793 mgExact identifier — unii candidate
15 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYGRANULE, FOR SOLUTION / ORAL5.5 mg/120mlExact identifier — unii candidate
34 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ASOLUTION / ORAL869 mgExact identifier — unii candidate
65 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36AGRANULE / ORAL1328 mgExact identifier — unii candidate
65 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36AINJECTION / INTRAMUSCULAR106.6 mgExact identifier — unii candidate
65 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ATABLET, EXTENDED RELEASE / ORAL1086 mgExact identifier — unii candidate
65 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKPOWDER, DENTIFRICE / DENTAL0.5 mg/mgExact identifier — unii candidate
15 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYGEL / DENTAL0.3 %w/wExact identifier — unii candidate
34 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ATROCHE / ORAL14594 mgExact identifier — unii candidate
65 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ASOLUTION / OPHTHALMIC4.7 %w/vExact identifier — unii candidate
65 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36AINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS980.4 mgExact identifier — unii candidate
65 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ASUSPENSION / OPHTHALMIC9 mgExact identifier — unii candidate
65 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30SUSPENSION, EXTENDED RELEASE / ORAL71 mgExact identifier — unii candidate
39 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TROCHE / ORAL315 mgExact identifier — unii candidate
39 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYPASTE, DENTIFRICE / DENTAL0.2 %w/wExact identifier — unii candidate
34 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36AINJECTION, POWDER, FOR SUSPENSION / SUBCUTANEOUS180 mgExact identifier — unii candidate
65 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ACAPSULE, EXTENDED RELEASE / ORAL160 mgExact identifier — unii candidate
65 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYSYRUP / ORAL24 mgExact identifier — unii candidate
34 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ATABLET, ORALLY DISINTEGRATING / SUBLINGUAL10.25 mgExact identifier — unii candidate
65 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYTABLET / SUBLINGUAL7 mgExact identifier — unii candidate
34 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ATABLET, DELAYED RELEASE / ORAL639 mgExact identifier — unii candidate
65 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYINJECTION / INTRAMUSCULAR22 mgExact identifier — unii candidate
34 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36AINJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS35 mgExact identifier — unii candidate
65 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36AINJECTION, SUSPENSION / INTRAMUSCULAR71 mgExact identifier — unii candidate
65 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYSUSPENSION / ORAL5000 mg/5mlExact identifier — unii candidate
34 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30IMPLANT / INTRAVITREALNAExact identifier — unii candidate
39 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ASUSPENSION/ DROPS / TOPICAL0.3 %w/vExact identifier — unii candidate
65 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36APOWDER, FOR SUSPENSION / INTRAMUSCULAR6.75 %w/vExact identifier — unii candidate
65 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30IMPLANT / SUBCUTANEOUS0.5 mgExact identifier — unii candidate
39 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36AINJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS181 mgExact identifier — unii candidate
65 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYSOLUTION / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
34 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36APOWDER, FOR SUSPENSION / ORAL7093 mgExact identifier — unii candidate
65 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKSOLUTION / RESPIRATORY (INHALATION)4.02 %w/vExact identifier — unii candidate
15 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYINJECTION / INTRAVENOUS22 mgExact identifier — unii candidate
34 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30PELLET / ORAL24 mgExact identifier — unii candidate
39 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30SUSPENSION / ORAL64 mgExact identifier — unii candidate
39 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, DELAYED RELEASE / ORAL144 mgExact identifier — unii candidate
39 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30POWDER / RESPIRATORY (INHALATION)0.13 mgExact identifier — unii candidate
39 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30GRANULE / ORAL629 mgExact identifier — unii candidate
39 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYCONCENTRATE / ORAL6 mgExact identifier — unii candidate
34 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYFILM, SOLUBLE / BUCCAL2 mgExact identifier — unii candidate
34 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ATABLET, COATED / ORAL177.7 mgExact identifier — unii candidate
65 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36AINJECTION / INTRAVENOUS15200 mgExact identifier — unii candidate
65 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYTABLET, ORALLY DISINTEGRATING / ORAL10 mgExact identifier — unii candidate
34 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ASUSPENSION/ DROPS / OPHTHALMIC3.3 %w/vExact identifier — unii candidate
65 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / SUBLINGUAL17.5 mgExact identifier — unii candidate
39 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYTABLET, FILM COATED / ORAL2 mgExact identifier — unii candidate
34 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ACAPSULE, DELAYED RELEASE / ORAL2043 mgExact identifier — unii candidate
65 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYPOWDER, FOR SOLUTION / ORAL199 mgExact identifier — unii candidate
34 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36AINJECTION, POWDER, FOR SUSPENSION / INTRAMUSCULAR164 mgExact identifier — unii candidate
65 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36AINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR300 mgExact identifier — unii candidate
65 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYTABLET / BUCCAL0.4 mgExact identifier — unii candidate
34 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ASUSPENSION, EXTENDED RELEASE / ORAL2464.6 mgExact identifier — unii candidate
65 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30LOZENGE / ORAL420 mgExact identifier — unii candidate
39 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYWAFER / ORAL8 mgExact identifier — unii candidate
34 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKFILM, SOLUBLE / ORAL14 mgExact identifier — unii candidate
15 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ASOLUTION, CONCENTRATE / INTRAVENOUS220 mgExact identifier — unii candidate
65 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ACAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
65 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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
9dbcc215-786b-4aa0-98da-da3508b1b1c9f142cf23-58fb-4078-9ab7-dca60934f8fc2025-04-18WarningsExact identifier
spl set id: f142cf23-58fb-4078-9ab7-dca60934f8fc

Reported adverse events (FAERS/openFDA)#

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