Revasol Peptic Relief
- Manufacturer
- Rnv LLC
- Effective date
- 2025-03-21
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 00:57:35
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each 30 mL dose) Purpose
Bismuth subsalicylate 525 mg...................Upset stomach reliever and antidiarrheal
OTC - PURPOSE SECTION
Upset stomach reliever and antidiarrheal
INDICATIONS & USAGE SECTION
Uses
relieves • travelers’ diarrhea • diarrhea • upset stomach due to overindulgence in food and drink, including:
• heartbun • indigestion • nausea • gas • belching • fullness
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.
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 • bloody or black stool
OTC - ASK DOCTOR SECTION
Ask a doctor before use if you have • fever • mucus in the stool
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you are taking any drug for
• anticoagulation (thinning 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
Stop use and ask a doctor if • symptoms get worse or last more than 2 days
• ringing in the ears or loss of hearing occurs • diarrhea lasts more than 2 days
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of the 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 • only with dosing cup provided
• adults and children 12 years and over:
• 30 mL (1 dose) every 1/2 hour or 60 mL (2 doses) every hour as needed for
diarrhea/traveler’s diarrhea
• 30 mL (1 dose) every 1/2 hour as needed for overindulgence (upset stomach,
heartburn, indigestion, nausea)
• do not exceed 8 doses (240 mL) in 24 hours
• use until diarrhea stops but no 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 contains: sodium 22 mg
• salicylate 249 mg • protect from freezing • avoid excessive heat (over 104°F
or 40°C)
•
TAMPER-EVIDENT FEATURE: Do not use if printed safety seal is torn, broken
or missing.
INACTIVE INGREDIENT SECTION
Inactive ingredients
anhydrous citric acid, benzoic acid, D&C Red #22,
D&C Red #28, flavor, purified water, salicylic acid, sodium citrate, sodium
salicylate, sorbic acid, sucralose, xanthan gum.
OTC - QUESTIONS SECTION
Questions or comments 1-888-446-4753
Monday - Friday (9 AM - 5 PM EST)
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 308762 | bismuth subsalicylate 525 MG in 30 mL Oral Suspension | PSN | 1 |
| 308762 | bismuth subsalicylate 17.5 MG/ML Oral Suspension | SCD | 1 |
| 308762 | bismuth subsalicylate 1.75 % Oral Suspension | SY | 1 |
| 308762 | bismuth subsalicylate 262 MG per 15 ML Oral Suspension | SY | 1 |
| 308762 | bismuth subsalicylate 524 MG per 30 ML Oral Suspension | SY | 1 |
| 308762 | bismuth subsalicylate 525 MG per 30 ML Oral Suspension | SY | 1 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| BISMUTH CATION Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 0be8e4ae-4d57-49f3-b3a9-e4728b4e8d15 | Product name | 1 | 20240313 |
| e2db08c6-133f-4f4f-afb4-e90a2418d6f6 | Product name | 1 | 20230320 |
| c6f86816-7da6-43ea-8c25-ac9758311cc5 | Product name | 1 | 20220118 |
| ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906 | Product name | 7 | 20210625 |
| f52be47f-7aa7-46c0-b1fa-50c18dd50206 | Product name | 1 | 20201029 |
| dea2eded-d1e7-46bb-9a3d-f8dc20de6277 | Product name | 1 | 20190408 |
| 11ed6f83-cdd2-4637-8379-b1a1d3ae3cde | Product name | 1 | 20181101 |
| 86c45a79-b9f0-4476-a27c-6e10db098497 | Product name | 1 | 20180125 |
| 252e11b6-1a9a-4283-a242-df2c129c496d | Product name | 3 | 20170717 |
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 84379-283-04 | Revasol Peptic Relief | 118 mL in 1 BOTTLE | LIQUID | 118 | 1 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Revasol Peptic Relief
- Bismuth subsalicylate
- ANHYDROUS CITRIC ACID
- SALICYLIC ACID
- XANTHAN GUM
- METHYL SALICYLATE
- WATER
- SODIUM SALICYLATE
- SUCRALOSE
- SODIUM CITRATE
- SORBIC ACID
- D&C RED NO. 22
- BISMUTH CATION
- D&C RED NO. 28
- BENZOIC ACID
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 84379-283 | 84379-283-04 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| SALICYLIC ACID | O414PZ4LPZ | IACT |
| XANTHAN GUM | TTV12P4NEE | IACT |
| METHYL SALICYLATE | LAV5U5022Y | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM SALICYLATE | WIQ1H85SYP | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| SODIUM CITRATE | 1Q73Q2JULR | IACT |
| SORBIC ACID | X045WJ989B | IACT |
| D&C RED NO. 22 | 1678RKX8RT | IACT |
| BISMUTH SUBSALICYLATE | 62TEY51RR1 | ACTIB |
| D&C RED NO. 28 | 767IP0Y5NH | IACT |
| BENZOIC ACID | 8SKN0B0MIM | 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 |
|---|---|---|---|---|---|---|
| Revasol Peptic Relief | BISMUTH SUBSALICYLATE | Rnv LLC | 30dc3a0a-3496-4bdf-e063-6394a90a62fd | 2025-03-21 | Warnings | 84379-283-04 84379-283 84379028304 30dc3a0a-3497-4bdf-e063-6394a90a62fd 30dc3a0a-3496-4bdf-e063-6394a90a62fd |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
