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#
Contacts and useful links#
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
| Age | Dose |
| adults and children
12 years and over | 30 mL at bedtime if needed
or as directed by a doctor |
| children under 12 years | do 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
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1248354 | diphenhydrAMINE HCl 50 MG in 30 mL Oral Solution | PSN | 1 |
| 1248354 | diphenhydramine hydrochloride 1.67 MG/ML Oral Solution | SCD | 1 |
| 1248354 | diphenhydramine HCl 1.667 MG/ML Oral Solution | SY | 1 |
| 1248354 | diphenhydramine HCl 50 MG per 30 ML Oral Solution | SY | 1 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| DIPHENHYDRAMINE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 0e2e0f88-b076-afe1-4bdd-32bca4375bec | Product name | 3 | 20250127 |
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
| 3e48c9c4-918d-5d23-2f0b-d2398b06be54 | Product name | 1 | 20140508 |
| 865c72dd-0d94-daac-f728-ddd4ded2a79e | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 84379-284-04 | REVASOL SLEEP AID | 118 mL in 1 BOTTLE | LIQUID | 118 | 1 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- REVASOL SLEEP AID
- Diphenhydramine HCl
- SUCRALOSE
- SORBITOL SOLUTION 70%
- WATER
- PROPYLENE GLYCOL
- DIPHENHYDRAMINE
- SODIUM BENZOATE
- FD&C RED NO. 40
- SODIUM CITRATE
- CITRIC ACID
- FD&C BLUE NO. 1
- GLYCERIN
- MENTHOL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 84379-284 | 84379-284-04 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| SORBITOL SOLUTION 70% | 8KW3E207O2 | IACT |
| WATER | 059QF0KO0R | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| DIPHENHYDRAMINE HCL | TC2D6JAD40 | ACTIB |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| SODIUM CITRATE | 1Q73Q2JULR | IACT |
| CITRIC ACID | 2968PHW8QP | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| MENTHOL | L7T10EIP3A | 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 SLEEP AID | DIPHENHYDRAMINE HCL | Rnv LLC | 30131010-be70-c940-e063-6394a90a190a | 2025-03-11 | Warnings | 84379-284-04 84379-284 84379028404 30131010-be71-c940-e063-6394a90a190a 30131010-be70-c940-e063-6394a90a190a |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
