Indications and uses
relieves • travelers’ diarrhea • diarrhea • upset stomach due to overindulgence in food and drink, including: • heartburn • indigestion • nausea • gas • belching • fullness
Sunmark stomach relief
- Manufacturer
- Strategic Sourcing Services LLC
- Effective date
- 2019-08-27
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 00:14:04
Label at a glance#
ProductSunmark stomach relief
Active ingredientBISMUTH SUBSALICYLATE
Label structure9 sections
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 1/2 to 1 hour as needed • do not exceed 8 doses (240 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 251 mg • low sodium • store at 20-25°C (68-77°F). Avoid excessive heat (over 104°F 40°C). • protect from freezing • for health information visit www.more-info.info
Contacts and useful links#
Websitewww.more-info.info
www.more-info.info
www.more-info.infoLabel contents#
Full prescribing information#
Active ingredient (in each 30 mL)
Bismuth subsalicylate 525 mg
Purposes
Upset stomach reliever and antidiarrheal
Uses
relieves
- travelers’ diarrhea
- diarrhea
- upset stomach due to overindulgence in food and drink, including:
- heartburn
- indigestion
- nausea
- gas
- belching
- fullness
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
- bloody or black stool
Ask a doctor before use if you have
- fever
- mucus in the stool
Ask a doctor or pharmacist before use if you are
taking any drug for
- anticoagulation (thinning 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
- symptoms get worse
- ringing in the ears or loss of hearing occurs
- diarrhea lasts more than 2 days
If pregnant or breast-feeding,
ask a 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 (1-800-222-1222).
Directions
- shake well before use
- only use the dose cup provided
- adults and children 12 years and over: 1 dose (30 mL) every 1/2 to 1 hour as needed
- do not exceed 8 doses (240 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
- each 30 mL contains: sodium 12 mg
- salicylate 251 mg
- low sodium
- store at 20-25°C (68-77°F). Avoid excessive heat (over 104°F 40°C).
- protect from freezing
- for health information visit www.more-info.info
Inactive ingredients
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 or comments?
1-800-719-9260
Principal Display Panel
COMPARE TO PEPTO-BISMOL® ACTIVE INGREDIENT
stomach relief liquid
Bismuth Subsalicylate 525 mg per 30 mL
Upset Stomach
Reliever/Antidiarrheal
Soothing relief for: nausea, upset stomach, heartburn, indigestion & diarrhea
REGULAR STRENGTH
ORIGINAL FLAVOR
GLUTEN FREE
8 FL OZ (237 mL)
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 49348-014-41 | ML - Milliliter | 49348-014 | 6fe871f7-b325-498d-b568-fb0e57e1ce71 | 1 | 2016-06-14 |
Products#
Every source-derived product name is available through these pages.
- Sunmark stomach relief
- Bismuth subsalicylate
- BISMUTH CATION
- SALICYLIC ACID
- D&C RED NO. 22
- D&C RED NO. 28
- GLYCERIN
- METHYL SALICYLATE
- CELLULOSE, MICROCRYSTALLINE
- CARBOXYMETHYLCELLULOSE SODIUM
- WATER
- SACCHARIN SODIUM
- DIMETHICONE
- SILICON DIOXIDE
- SODIUM SALICYLATE
- SORBIC ACID
- XANTHAN GUM
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 49348-014 | 49348-014-41 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| BISMUTH SUBSALICYLATE | 62TEY51RR1 | ACTIB |
| D&C RED NO. 22 | 1678RKX8RT | IACT |
| D&C RED NO. 28 | 767IP0Y5NH | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| METHYL SALICYLATE | LAV5U5022Y | IACT |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | IACT |
| WATER | 059QF0KO0R | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| SALICYLIC ACID | O414PZ4LPZ | IACT |
| DIMETHICONE | 92RU3N3Y1O | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| SODIUM SALICYLATE | WIQ1H85SYP | IACT |
| SORBIC ACID | X045WJ989B | 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 |
|---|---|---|---|---|---|---|
| 3ad62e98-f0e6-479f-9248-e3166a1cb03e | d7f332b0-bfb4-488f-bc82-61698bc5f91d | 2020-04-14 | Warnings | d7f332b0-bfb4-488f-bc82-61698bc5f91d |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.