SPL UNCLASSIFIED SECTION
Drug Facts
Drug Facts
Active ingredient
(in each 30 mL dose cup or 2 tablespoons)
Bismuth subsalicylate 1050 mg
Purposes
Bismuth subsalicylate ....................... Upset stomach reliever
and antidiarrheal
Uses relieves ■ travelers' diarrhea ■ diarrhea ■ upset stomach
due to overindulgence of food and drink including: ■ heart burn ■
indigestion ■ nausea ■ gas ■ belching
Warnings
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 ■ an ulcer
■ a bleeding problem ■ black or bloody stool
Ask a doctor before use if you have
■ fever ■ mucus in stool
Ask a doctor or pharmacist before use if you are
taking any drug for ■ anticoagulation (thinning of the blood)
■ diabetes ■ gout ■ arthritis
When using this product a temporary, but harmless, darkening
of the stool and/or tongue may occur
Stop use and ask a doctor if
■ diarrhea lasts more than 2 days
■ symptoms get worse or last more than 2 days
■ ringing in the ears or loss of hearing occurs
If pregnant or breast feeding, ask health professional before use.
Keep out of reach of children. In case of overdose, get medical
help or contact a Poison Control Center right away.
Directions ■ Shake well before use
■ use dose cup or tablespoon (TBSP)
■ adults and children 12 years and over: 1 dose (30 mL or 2
TBSP) every 1 hour as needed
■ do not exceed 4 doses (120 mL or 8 TBSP) 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
■ each 30 mL dose cup contains: sodium 13 mg, salicylate 455 mg ■ protect
from freezing ■ avoid excessive heat (over 104°F or 40°C) ■ low sodium
Inactive ingredients benzoic acid, D&C red #22, D&C red #28,
flavor, purified water, saccharin sodium, salicylic acid, sodium salicylate, xantham gum
NDC 68998-558-28 * Compare to the active
ingredients in Pepto-BismolTM
Maximum Strength
Marc's
ULTRA STRENGTH
Stomach Relief
Antidiarrheal / Upset Stomach Reliever
Bismuth subsalicylate
5 Symptoms Relief of
• Nausea • Upset Stomach•
• Heartburn • Diarrhea
• Indigestion
12 FL OZ (354 mL)
TAMPER EVIDENT: Do not use if imprinted shrinkband is
missing or broken
*Thls product is not manufactured or dlstnbuted by Procter & Gamble, Inc"
distributor of Pepto BismolTM
Distributed by: LR-144
Marc Glassman, Inc.
West 130th Street
Cleveland, OH 44130
Lot.
Exp.
res
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 308763 | bismuth subsalicylate 1050 MG in 30 mL Oral Suspension | PSN | 3 |
| 308763 | bismuth subsalicylate 35 MG/ML Oral Suspension | SCD | 3 |
| 308763 | bismuth subsalicylate 1050 MG per 30 ML Oral Suspension | SY | 3 |
| 308763 | bismuth subsalicylate 525 MG per 15 ML Oral Suspension | SY | 3 |
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0094442001848 | GTIN-13: 0094442001848 EAN-13: 0094442001848 GTIN-12: 094442001848 UPC-A: 094442001848 GTIN storage (14 digits): 00094442001848 | 558-28.jpg |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| c6f86816-7da6-43ea-8c25-ac9758311cc5 | Product name | 1 | 20220118 |
| dea2eded-d1e7-46bb-9a3d-f8dc20de6277 | Product name | 1 | 20190408 |
| 252e11b6-1a9a-4283-a242-df2c129c496d | Product name | 3 | 20170717 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68998-558-28 | 2025-12-26 | C162847 | 48780-1 | f386c649-e17b-0266-e053-dadaa90a7c1a | Stomach Relief, Ultra Strength |
| 68998-558-28 | 2023-01-30 | C162847 | 48780-1 | f386c649-e17b-0266-e053-dadaa90a7c1a | Stomach Relief, Ultra Strength |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68998-558-28 | Stomach Relief, Ultra Strength | 354 mL in 1 BOTTLE | SUSPENSION | 354 | 3 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 68998-558 | 68998-558-28 |
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 |
| WATER | 059QF0KO0R | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| SALICYLIC ACID | O414PZ4LPZ | IACT |
| SODIUM SALICYLATE | WIQ1H85SYP | 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 |
|---|---|---|---|---|---|---|
| Stomach Relief, Ultra Strength | BISMUTH SUBSALICYLATE | Marc Glassman, Inc. | 8e47d007-237c-45c7-88c5-83953a06e4bd | 2025-12-26 | Warnings | 68998-558-28 68998-558 68998055828 182ef664-b0b4-47c0-9453-27bc5d80d0f0 8e47d007-237c-45c7-88c5-83953a06e4bd |
Adverse event summaries are temporarily unavailable. Other product information remains available.