REVASOL PEPTIC RELIEF- bismuth subsalicylate liquid

Revasol Peptic Relief by

Drug Labeling and Warnings

Revasol Peptic Relief by is a Otc medication manufactured, distributed, or labeled by Rnv LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient (in each 30 mL dose) Purpose

Bismuth subsalicylate 525 mg...................Upset stomach reliever and antidiarrheal

PURPOSE

Upset stomach reliever and antidiarrheal

INDICATIONS & USAGE

Uses

relieves travelers’ diarrhea diarrhea upset stomach due to overindulgence in food and drink, including:
heartbun indigestion nausea gas belching fullness

WARNINGS

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

Do not use if you have an ulcer a bleeding problem bloody or black stool

ASK DOCTOR

Ask a doctor before use if you have fever mucus in the stool

ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are taking any drug for
anticoagulation (thinning the blood) diabetes gout arthritis

WHEN USING

When using this product a temporary, but harmless, darkening of the stool
and/or tongue may occur

STOP USE

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

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of the reach of children. In case of overdose, get medical help or
contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

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

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.

QUESTIONS

Questions or comments 1-888-446-4753
Monday - Friday (9 AM - 5 PM EST)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

REVASOL PEPTIC RELIEF 
bismuth subsalicylate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84379-283
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ, BISMUTH CATION - UNII:ZS9CD1I8YE)	BISMUTH SUBSALICYLATE	525 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SALICYLIC ACID (UNII: O414PZ4LPZ)
XANTHAN GUM (UNII: TTV12P4NEE)
METHYL SALICYLATE (UNII: LAV5U5022Y)
WATER (UNII: 059QF0KO0R)
SODIUM SALICYLATE (UNII: WIQ1H85SYP)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SORBIC ACID (UNII: X045WJ989B)
D&C RED NO. 22 (UNII: 1678RKX8RT)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
BENZOIC ACID (UNII: 8SKN0B0MIM)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84379-283-04	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/03/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M008	02/03/2025

Labeler - Rnv LLC (118917568)

Registrant - Rnv LLC (118917568)

Establishment
Name	Address	ID/FEI	Business Operations
Rnv LLC		118917568	manufacture(84379-283)