REVASOL CHILDRENS ALLERGY
- Manufacturer
- Rnv LLC
- Effective date
- 2025-03-26
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 00:58:00
Label at a glance#
ProductREVASOL CHILDRENS ALLERGY
Active ingredientDIPHENHYDRAMINE HCL
Label structure13 sections
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each 5 mL)
Purpose
Diphenhydramine HCl 12.5mg..........................................................Antihistamine
OTC - PURPOSE SECTION
Purpose
Antihistamine
INDICATIONS & USAGE SECTION
Uses
• temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
• runny nose • sneezing • itchy, watery eyes • itching of the nose or throat
WARNINGS SECTION
Warnings
OTC - DO NOT USE SECTION
Do not use • to make a child sleepy • with any other product containing diphenhydramine, even on one used on skin
OTC - ASK DOCTOR SECTION
Ask a doctor before use if the child has
• a breathing problem such as chronic bronchitis • glaucoma
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers
OTC - WHEN USING SECTION
When using this product
• marked drowsiness may occur • sedatives and tranquilizers may increase drowsiness • excitability may occur, especially in children
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
• find the right dose on chart below
• mL=mililiter • take every 4 to 6 hours, or as directed by a doctor • do not take more than 6 doses in 24 hours • use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.
| Age | Dose |
| children 6 to 11 years | 5 mL to 10 mL |
| children 2 to 5 years | do not use unless directed by a doctor |
| children under 2 years | do not use |
OTHER SAFETY INFORMATION
Other information
•
each 5 mL 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, D&C Red #33, FD&C Red #40, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sodium
citrate, sorbitol solution, 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 |
|---|---|---|---|
| 1049906 | diphenhydrAMINE HCl 12.5 MG in 5 mL Oral Solution | PSN | 1 |
| 1049906 | diphenhydramine hydrochloride 2.5 MG/ML Oral Solution | SCD | 1 |
| 1049906 | diphenhydramine HCl 12.5 MG per 5 ML Oral Solution | SY | 1 |
| 1049906 | diphenhydramine hydrochloride 25 MG per 10 ML Oral Solution | SY | 1 |
| 1049906 | diphenhydramine hydrochloride 50 MG per 20 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 |
| e2db08c6-133f-4f4f-afb4-e90a2418d6f6 | Product name | 1 | 20230320 |
| ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906 | Product name | 7 | 20210625 |
| f52be47f-7aa7-46c0-b1fa-50c18dd50206 | Product name | 1 | 20201029 |
| 11ed6f83-cdd2-4637-8379-b1a1d3ae3cde | Product name | 1 | 20181101 |
| 86c45a79-b9f0-4476-a27c-6e10db098497 | Product name | 1 | 20180125 |
| 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 |
|---|---|---|---|---|---|---|
| 84379-286-04 | REVASOL CHILDRENS ALLERGY | 118 mL in 1 BOTTLE | LIQUID | 118 | 1 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- REVASOL CHILDRENS ALLERGY
- DIPHENHYDRAMINE HCL
- WATER
- SUCRALOSE
- SORBITOL SOLUTION 70%
- SODIUM BENZOATE
- PROPYLENE GLYCOL
- SODIUM CITRATE
- D&C RED NO. 33
- DIPHENHYDRAMINE
- MENTHOL
- FD&C RED NO. 40
- GLYCERIN
- ANHYDROUS CITRIC ACID
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 84379-286 | 84379-286-04 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| WATER | 059QF0KO0R | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| SORBITOL SOLUTION 70% | 8KW3E207O2 | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| SODIUM CITRATE | 1Q73Q2JULR | IACT |
| D&C RED NO. 33 | 9DBA0SBB0L | IACT |
| DIPHENHYDRAMINE HCL | TC2D6JAD40 | ACTIB |
| MENTHOL | L7T10EIP3A | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| ANHYDROUS CITRIC ACID | XF417D3PSL | 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 CHILDRENS ALLERGY | DIPHENHYDRAMINE HCL | Rnv LLC | 3143137f-ef42-5358-e063-6394a90a8ed1 | 2025-03-26 | Warnings | 84379-286-04 84379-286 84379028604 3143137f-ef43-5358-e063-6394a90a8ed1 3143137f-ef42-5358-e063-6394a90a8ed1 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.