FDA.reportPublic FDA data

Leader stomach relief

Manufacturer
Cardinal Health
Effective date
2018-02-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:03:45

Label at a glance#

ProductLeader stomach relief
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 • belching • fullness

Dosage and administration

• shake well before use • only use the dose cup provided • adults and children 12 years and over: 1 dose (30 mL) every hour as needed • do not exceed 4 doses (120 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 30 mL contains: sodium 12 mg • salicylate 457 mg • low sodium • store at 20-25 ° C (68-77 ° F). Avoid excessive heat (over 104 ° F or 40 ° C). • protect from freezing • for health information visit www.more-info.info

Label contents#

Full prescribing information#

Active ingredient (in each 30 mL)

OTC - ACTIVE INGREDIENT SECTION

Bismuth subsalicylate 1050 mg

Purposes

OTC - PURPOSE SECTION

Upset stomach reliever and antidiarrheal

Uses

INDICATIONS & USAGE SECTION

relieves

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

OTC - DO NOT USE SECTION

if you have

  • an ulcer
  • a bleeding problem
  • bloody or black stool

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
  • diarrhea lasts more than 2 days
  • ringing in the ears or loss of hearing occurs

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 (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

  • shake well before use
  • only use the dose cup provided
  • adults and children 12 years and over: 1 dose (30 mL) every hour as needed
  • do not exceed 4 doses (120 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 30 mL contains: sodium 12 mg
  • salicylate 457 mg
  • low sodium
  • store at 20-25°C (68-77°F). Avoid excessive heat (over 104°F or 40°C).
  • protect from freezing
  • for health information visit www.more-info.info

Inactive ingredients

INACTIVE INGREDIENT SECTION

D&C red #22, D&C red #28, glycerin, hydroxyethyl cellulose, methyl salicylate, microcrystalline cellulose and carboxymethylcellulose sodium, purified water, saccharin sodium, salicylic acid, simethicone, sodium salicylate, sorbic acid, xanthan gum

Questions?

OTC - QUESTIONS SECTION

1-800-719-9260

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Maximum Strength

Stomach Relief

Bismuth Subsalicylate 1050 mg per 30 mL

Upset Stomach Reliever

Antidiarrheal

COMPARE TO PEPTO-BISMOL® MAX STRENGTH active ingredient

5 Symptom Digestive Relief

Heartburn

Indigestion

Nausea

Upset Stomach

Diarrhea

100% Money Back Guarantee

8 FL OZ (237mL)

stomach relief image
stomach relief image

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70000-035470000-0354-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
BISMUTH SUBSALICYLATE62TEY51RR1ACTIB
D&C RED NO. 221678RKX8RTIACT
D&C RED NO. 28767IP0Y5NHIACT
GLYCERINPDC6A3C0OXIACT
METHYL SALICYLATELAV5U5022YIACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT
WATER059QF0KO0RIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SALICYLIC ACIDO414PZ4LPZIACT
DIMETHICONE92RU3N3Y1OIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM SALICYLATEWIQ1H85SYPIACT
SORBIC ACIDX045WJ989BIACT
XANTHAN GUMTTV12P4NEEIACT

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
885bf012-5b9a-4bab-ada7-bfa19f44622ab07b97c4-8c38-4718-b272-e83b1f32f86c2020-04-15WarningsExact identifier
spl set id: b07b97c4-8c38-4718-b272-e83b1f32f86c

Reported adverse events (FAERS/openFDA)#

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