REVASOL SLEEP AID

Manufacturer
Rnv LLC
Effective date
2025-03-11
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:57:18

Label at a glance#

ProductREVASOL SLEEP AID
Active ingredientDIPHENHYDRAMINE HCL
Label structure15 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each 30 mL dose cup) Purpose
Diphenhydramine HCl 50mg.................................................... Nightime sleep-aid

OTC - PURPOSE SECTION

Nightime sleep-aid

INDICATIONS & USAGE SECTION

Uses
• for the relief of occasional sleeplessness
• reduces time to fall asleep if you have difficulty falling asleep

WARNINGS SECTION

Warnings

Do not use
• for children under 12 years of age
• with any other product containing diphenhydramine, even one used on skin
• with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have
• a breathing problem such as emphysema or chronic bronchitis
• glaucoma
• difficulty in urination due to enlargement of the prostate gland

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking sedatives or
tranquilizers

OTC - WHEN USING SECTION

When using this product
• avoid alcoholic beverages

OTC - STOP USE SECTION

Stop use and ask a doctor if sleeplessness persists continuosly for more than 2
weeks. Insomnia may be a symptom of serious underlying medical ilness.

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 (1-800-222-1222).

DOSAGE & ADMINISTRATION SECTION

Directions
• take only one dose (30 mL) per day (24 hours)
• only use dose cup provided

AgeDose
adults and children
12 years and over
30 mL at bedtime if needed
or as directed by a doctor
children under 12 yearsdo not use

OTHER SAFETY INFORMATION

Other information
• each 30 mL dose cup contains: sodium 4 mg
• store between 15-30°C (59-86°F).
• TAMPER-EVIDENT FEATURE: Do not use if printed safety seal is torn, broken or
missing.

INACTIVE INGREDIENT SECTION

Inactive ingredients anhydrous citric acid, FD&C Blue #1, FD&C Red #40,
flavor, glycerin, menthol, propylene glycol, purified water, sodium benzoate,
sodium citrate, sorbitol, sucralose.

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

REVASOL SLEEP.jpgREVASOL SLEEP.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1248354diphenhydrAMINE HCl 50 MG in 30 mL Oral SolutionPSN1
1248354diphenhydramine hydrochloride 1.67 MG/ML Oral SolutionSCD1
1248354diphenhydramine HCl 1.667 MG/ML Oral SolutionSY1
1248354diphenhydramine HCl 50 MG per 30 ML Oral SolutionSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIPHENHYDRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84379-284-04REVASOL SLEEP AID118 mL in 1 BOTTLELIQUID1181

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84379-284REVASOL SLEEP AID (DIPHENHYDRAMINE HCL) LIQUID [RNV LLC]1Current NDC, 1 package rows20250321_30131010-be70-c940-e063-6394a90a190a.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84379-28484379-284-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 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 SLEEP AIDDIPHENHYDRAMINE HCLRnv LLC30131010-be70-c940-e063-6394a90a190a2025-03-11WarningsExact identifier
ndc (package): 84379-284-04
ndc (product): 84379-284
ndc11 (package): 84379028404
spl id: 30131010-be71-c940-e063-6394a90a190a
spl set id: 30131010-be70-c940-e063-6394a90a190a

Reported adverse events (FAERS/openFDA)#

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