Indications and uses
For the relief of occasional sleeplessness reduces time to fall asleep if you have difficulty falling asleep
AXIV - VroZzz
- Manufacturer
- Vivunt Pharma LLC | SOFTECH PHARMA PRIVATE LIMITED
- Effective date
- 2025-09-17
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 5
- Source
- full-release
- Hydrated at
- 2026-06-01 01:13:58
Label at a glance#
ProductAXIV - VroZzz
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure9 sections
Dosage and administration
take only 2 softgels per day (24 hours) adults & children 12 years and over take 2 softgels at bedtime if needed, or as directed by a doctor children under 12 years do not use
Storage and handling
store between 20-25°C (68-77 °F) tamper-evident: Do not use if carton is open or if the foil inner seal is broken or missing.
Contacts and useful links#
Websitewww.vivunt.live
www.vivunt.live
www.vivunt.liveLabel contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
Diphenhydramine HCl
OTC - PURPOSE SECTION
| Active Ingredient (in each softgel) | Purpose |
| Diphenhydramine HCl 25 mg | Nighttime Sleep-Aid |
Uses
- For the relief of occasional sleeplessness
- reduces time to fall asleep if you have difficulty falling asleep
Warnings
Do not use
- for children under 12 years of age
- with any other product containing diphenhydramine, even one used on skin
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
Ask a doctor or pharmacist before use if you are
taking sedatives or tranquilizers
When using this product
avoid alcoholic beverages
Stop use and ask a doctor if
sleeplessness persists continuously for more than 2 weeks, consult your doctor. Insomnia may be a symptom of a serious underlying medical illness.
If pregnant or breast-feeding,
ask a health professional before use.
Keep out of reach of children
Keep out of reach of children.
Overdose warning
Do not take more than recommended dosage. In case of overdose, get medical help or contact a Poison Control Center. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
- take only 2 softgels per day (24 hours)
| adults & children 12 years and over | take 2 softgels at bedtime if needed, or as directed by a doctor |
| children under 12 years | do not use |
Other information
- store between 20-25°C (68-77 °F)
- tamper-evident: Do not use if carton is open or if the foil inner seal is broken or missing.
Inactive ingredients
FD&C Blue No. 1, FD&C Red No. 40, Gelatin, Glycerin, Methylparaben, Polyethylene Glycol 400, Propylparaben, Purified Water, Sorbitol, Titanium Dioxide.
SPL UNCLASSIFIED SECTION
This product is not manufactured or distributed by The Procter & Gamble Company, owner of the registered trademark VICKS® ZzzQuil® Nighttime Sleep-Aid LiquidCaps™.
Lic. No.: "DD/DRUGS/DD/416"
Distributed by: Vivunt Pharma LLC
8590 w 74TH Court, Suite 1901
Miami, FL 33156-3178
Made in India
PRINCIPAL DISPLAY PANEL
Compare to VICKS® ZzzQuil®
Nighttime Sleep-Aid LiquidCaps™ active ingredient*
NDC 82706-014-01
AXIV - VroZzz
Sleep Aid
For Nighttime Use
Fast Acting
Non-Habit Forming
Diphenhydramine HCl
72 Softgels** **Liquid-filled capsules
DailyMed RxNorm Mappings#
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 |
| 3e48c9c4-918d-5d23-2f0b-d2398b06be54 | Product name | 1 | 20140508 |
| 6084a4f4-5437-c9a5-caec-5361ee075a59 | Product name | 1 | 20140508 |
| 865c72dd-0d94-daac-f728-ddd4ded2a79e | Product name | 1 | 20140508 |
| 90c5639a-61b0-88d6-ddcf-21888e94869a | Product name | 1 | 20140508 |
| 9514609b-a2a9-f8ec-6ba6-3f8e5ee89877 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 82706-014-01 | AXIV - VroZzz | 12 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 12 | 5 | |
| 82706-014-01 | AXIV - VroZzz | 6 in 1 CARTON | CAPSULE, LIQUID FILLED | 6 | 5 |
Products#
Every source-derived product name is available through these pages.
- AXIV - VroZzz
- Diphenhydramine Hydrochloride
- FD&C BLUE NO. 1
- FD&C RED NO. 40
- GELATIN
- GLYCERIN
- METHYLPARABEN
- POLYETHYLENE GLYCOL 400
- PROPYLPARABEN
- WATER
- SORBITOL
- TITANIUM DIOXIDE
- DIPHENHYDRAMINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 82706-014 | 82706-014-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| GELATIN | 2G86QN327L | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
| WATER | 059QF0KO0R | IACT |
| SORBITOL | 506T60A25R | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| DIPHENHYDRAMINE HYDROCHLORIDE | TC2D6JAD40 | ACTIB |
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 |
|---|---|---|---|---|---|---|
| AXIV - VroZzz | DIPHENHYDRAMINE HYDROCHLORIDE | Vivunt Pharma LLC | 131a60cf-02ec-5a5b-e063-6294a90abd1f | 2025-09-17 | Warnings | 82706-014-01 82706-014 82706001401 3f053ed8-8c2a-be03-e063-6294a90ae5b7 131a60cf-02ec-5a5b-e063-6294a90abd1f |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.