Stomach Relief
- Manufacturer
- Demoulas Super Markets Inc | AptaPharma Inc.
- Effective date
- 2023-12-29
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-06-01 00:06:00
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (In each 30 mL dose cup or 2 tablespoons)
Bismuth subsalicylate 1050 mg
OTC - PURPOSE SECTION
Purposes
Bismuth subsalicylate .............. Upset stomach reliever
and antidiarrheal
INDICATIONS & USAGE SECTION
Uses
relieves ■ travelers' diarrhea ■ diarrhea
■ upset stomach due to overindulgence of food and
drink including: ■ heart burn ■ indigestion
■ nausea ■ gas ■ belching
WARNINGS SECTION
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.
SPL UNCLASSIFIED SECTION
Allergy alert: Contains salicylate. Do not take if you are
■ allergic to salicylates (including aspirin)
■ taking other salicylate products
OTC - DO NOT USE SECTION
Do not use if you have ■ an ulcer
■ a bleeding problem ■ black or bloody stool
OTC - ASK DOCTOR SECTION
Ask a doctor before use if you have
■ fever ■ mucus in stool
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you are taking
any drug for ■ anticoagulation (thinning of the blood)
■ diabetes ■ gout ■ arthritis
OTC - WHEN USING SECTION
When using this product a temporary, but harmless,
darkening of the stool and/or tongue may occur
OTC - STOP USE SECTION
Slop 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
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast feeding, ask health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison
Control Center right away.
DOSAGE & ADMINISTRATION SECTION
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 SAFETY INFORMATION
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 INGREDIENT SECTION
Inactive ingredients
benzoic acid, D&C red # 22, D&C red # 28, flavor,
purified water, saccharin sodium, salicylic acid,
sodium salicylate, xanthan gum
OTC - QUESTIONS SECTION
Questions? 1-877-798-5944
Principal Display Panel
MARKET
BASKET®
"MORE FOR YOUR DOLLAR"
*COMPARE TO
The active ingredient in
PEPTO-BISMOL™ Maximum Strength
Stomach Relief↓
MAXIMUM STRENGTH
Bismuth Subsalicylate
Antidiarrheal / Upset Stomach Reliever
5 Symptom Relief of:
• Nausea • Upset Stomach
• Heartburn • Diarrhea
• Indigestion
8 FL OZ (237 mL)
TAMPER EVIDENT: Do not use if imprinted
shrinkband is missing or broken
*This product is not manufactured or distributed by Procter & Gamble,
Inc., the distributor of Pepto-Bismol™.
DISTRIBUTED BY Made in USA
DEMOULAS SUPERMARKETS INC. LR·089 REV01
875 EAST STREET
TEWKSBURY, MA 01876
0 49705 73076 8 PEEL
HERE
↓Principal Display Label↓
Stomach Relief, Maximum Strength by Market Basket®
res
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 308763 | bismuth subsalicylate 1050 MG in 30 mL Oral Suspension | PSN | 2 |
| 308763 | bismuth subsalicylate 35 MG/ML Oral Suspension | SCD | 2 |
| 308763 | bismuth subsalicylate 1050 MG per 30 ML Oral Suspension | SY | 2 |
| 308763 | bismuth subsalicylate 525 MG per 15 ML Oral Suspension | SY | 2 |
DailyMed Product Concepts#
| 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 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53942-558-26 | Stomach ReliefMaximum Strength | 237 mL in 1 BOTTLE | SUSPENSION | 237 | 2 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Stomach Relief Maximum Strength
- BISMUTH SUBSALICYLATE
- SALICYLIC ACID
- BENZOIC ACID
- D&C RED NO. 22
- D&C RED NO. 28
- WATER
- SACCHARIN SODIUM
- SODIUM SALICYLATE
- XANTHAN GUM
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 53942-558 | 53942-558-26 |
Ingredients#
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 |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Stomach Relief Maximum Strength | BISMUTH SUBSALICYLATE | Demoulas Super Markets Inc | b2d55045-d4a4-4167-a20c-42932f35bab2 | 2023-12-29 | Warnings | 53942-558-26 53942-558 53942055826 9c832971-fd38-4183-acd5-d520aae9c8f6 b2d55045-d4a4-4167-a20c-42932f35bab2 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
