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#

ProductRevasol Peptic Relief
Active ingredientBISMUTH SUBSALICYLATE
Label structure16 sections

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

REVASOL PEPTIC RELIEFREVASOL PEPTIC RELIEF

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308762bismuth subsalicylate 525 MG in 30 mL Oral SuspensionPSN1
308762bismuth subsalicylate 17.5 MG/ML Oral SuspensionSCD1
308762bismuth subsalicylate 1.75 % Oral SuspensionSY1
308762bismuth subsalicylate 262 MG per 15 ML Oral SuspensionSY1
308762bismuth subsalicylate 524 MG per 30 ML Oral SuspensionSY1
308762bismuth subsalicylate 525 MG per 30 ML Oral SuspensionSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BISMUTH CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0be8e4ae-4d57-49f3-b3a9-e4728b4e8d15Product name120240313
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84379-283-04Revasol Peptic Relief118 mL in 1 BOTTLELIQUID1181

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84379-283REVASOL PEPTIC RELIEF (BISMUTH SUBSALICYLATE) LIQUID [RNV LLC]1Current NDC, 1 package rows20250323_30dc3a0a-3496-4bdf-e063-6394a90a62fd.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84379-28384379-283-04

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Source Document#

Source XML

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Revasol Peptic ReliefBISMUTH SUBSALICYLATERnv LLC30dc3a0a-3496-4bdf-e063-6394a90a62fd2025-03-21WarningsExact identifier
ndc (package): 84379-283-04
ndc (product): 84379-283
ndc11 (package): 84379028304
spl id: 30dc3a0a-3497-4bdf-e063-6394a90a62fd
spl set id: 30dc3a0a-3496-4bdf-e063-6394a90a62fd

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.