shake well before use mL = milliliter TBSP = tablespoon adults and children 12 years and over: 1 dose (2 TBSP or 30 mL) every hour as needed do not exceed 4 doses (8 TBSP or 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
each 30 mL or 2 TBSP contains: potassium 25 mg salicylate 471 mg sodium 8 mg protect from freezing avoid excessive heat (over 104 o F or 40 o C) dosage cup provided
Bismuth subsalicylate 1050 mg
Upset stomach reliever and anti-diarrheal
relieves:
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
taking any drug for
a temporary, but harmless darkening of the stool and/or tongue may occur
ask a health professional before use.
In case of overdose, get medical help or contact a Poison Control Center immediately.
benzoic acid, D&C red # 22, D&C red # 28, flavor, hydroxyethyl cellulose, potassium hydroxide, purified water, saccharin sodium, salicylic acid, simethicone, xanthan gum
LEADER
NDC 70000-0440-1
Maximum Strength
Stomach Relief
Bismuth Subsalicylate, 1050 mg
Upset Stomach Reliever / Antidiarrheal)
COMPARE TO PEPTO-BISMOL ULTRA active ingredient*
5 Symptom Digestive Relief:
Diarrhea, Heartburn, Indigestion, Nausea & Upset Stomach
12 FL OZ (354 mL)
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 70000-0440-1 | 2025-08-22 | C162847 | 48780-1 | 1030e365-34d8-111a-e063-dadaa90a10e2 | Leader Maximum Strength Stomach Relief |
| 70000-0440-1 | 2024-01-30 | C162847 | 48780-1 | 1030e365-34d8-111a-e063-dadaa90a10e2 | Leader Maximum Strength Stomach Relief |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 70000-0440 | LEADER MAXIMUM STRENGTH STOMACH RELIEF (BISMUTH SUBSALICYLATE) LIQUID [CARDINAL HEALTH 110, LLC. DBA LEADER] | 4 | Legacy NDC | 20220111_eac79ee8-0699-4308-b682-ee04a7c7f4c5.zip |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 70000-0440-1 | ML - Milliliter | 70000-0440 | 99bbb9a1-5128-460a-b1a8-1a6f82a3cbf2 | 1 | 2020-03-10 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 70000-0440 | 70000-0440-1 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| BISMUTH SUBSALICYLATE | 62TEY51RR1 | ACTIB |
| BENZOIC ACID | 8SKN0B0MIM | IACT |
| D&C RED NO. 22 | 1678RKX8RT | IACT |
| D&C RED NO. 28 | 767IP0Y5NH | IACT |
| POTASSIUM HYDROXIDE | WZH3C48M4T | IACT |
| WATER | 059QF0KO0R | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| SALICYLIC ACID | O414PZ4LPZ | IACT |
| HYDROXYETHYL CELLULOSE (1500 MPA.S AT 1%) | L605B5892V | IACT |
| DIMETHICONE | 92RU3N3Y1O | IACT |
| XANTHAN GUM | TTV12P4NEE | IACT |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| ff4fe946-e0a1-4af1-b379-719edbd01194 | eac79ee8-0699-4308-b682-ee04a7c7f4c5 | 2025-08-22 | Warnings | eac79ee8-0699-4308-b682-ee04a7c7f4c5 |
Adverse event summaries are temporarily unavailable. Other product information remains available.