FDA.reportPublic FDA data

AXIV Sinus Severe Nasal Spray

Manufacturer
VIVUNT PHARMA LLC | Midas Care Pharmaceuticals Pvt Ltd
Effective date
2026-06-23
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
monthly-update
Hydrated at
2026-07-17 21:35:33

Label at a glance#

ProductAXIV Sinus Severe Ultra Fine Mist
Active ingredientOXYMETAZOLINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

temporarily relieves nasal congestion due to a cold hay fever or other upper respiratory allergies sinus congestion and pressure.

Dosage and administration

adults and children 6 to under 12 years of age (with adult supervision): 2 or 3 sprays in each nostril not more than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period. children under 6 years of age: ask a doctor To Use remove protective cap before using for the first time, prime the pump by firmly depressing its rim several times hold container with thumb at base and nozzle between first and second...

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

  • Oxymetazoline HCl 0.05%

Purpose

OTC - PURPOSE SECTION

  • Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves nasal congestion due to a cold
  • hay fever or other upper respiratory allergies
  • sinus congestion and pressure.

Warnings

WARNINGS SECTION

Warnings

When using this product

OTC - WHEN USING SECTION

  • Do not exceed recommended dosage
  • do not use this product for more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen.
  • do not use this product if you have
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor.
  • this product may cause temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge.
  • use of this comtainer by more than one person may spread infection.

Stop use and ask a doctor

OTC - ASK DOCTOR SECTION

if symptoms persist.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OVERDOSAGE SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 6 to under 12 years of age (with adult supervision): 2 or 3 sprays in each nostril not more than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period.
  • children under 6 years of age: ask a doctor

To Use

  • remove protective cap
  • before using for the first time, prime the pump by firmly depressing its rim several times
  • hold container with thumb at base and nozzle between first and second fingers
  • without tilting your head, inset nozzle into nostril
  • fully depress rim with a firm, even stroke and inhale deeply.

How to use:

Hold white tabs; SQUEEZE grooved area of cap FIRMLY and turn counter clockwise. Secure cap after use.

DirectionsDirections

Other information

OTHER SAFETY INFORMATION

  • Store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

Benzalkonium chloride, Edetate disodium, Polyethylene glycol, Propylene glycol, Purified water, Polyvinylpyrrolidone, Sodium phosphate dibasic dihydrate, Sodium Phosphate monobasic monohydrate.

SPL UNCLASSIFIED SECTION

Distributed by: VIVUNT PHARMA LLC

8950 SW 74th Court, Suite 1901

Miami, FL 33156-3178. USA.

Product from India.

www.vivunt.live

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

axiv®

Sinus SEVERE

UNBLOCKS IN SECONDS

  • Nasal Decongestant
  • Ultra Fine Mist

MAX STRENGTH

12 HOURS 265 SPRAYS

NON-DROWSY

Oxymetazoline HCl 0.05%

0.5 Fl OZ (15ml)

PDP1PDP1

BOTTLEBOTTLE

WHY A SPRAY WORKS FASTER

Targets congestion directly.

No digestion

Relief in Seconds.

Oxymetazoline CHl 0.05%

Part of the AXIV Sinus System

  • AXIV Sinus Severe

Maximum Strength Day Use.

  • AXIV Sinus Severe + Cool

Maximum Strength + Cooling Day Use.

  • AXIV Sinus Overnight

Breath clear all night.

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130850047780683GTIN-13: 0850047780683
EAN-13: 0850047780683
GTIN-12: 850047780683
UPC-A: 850047780683
GTIN storage (14 digits): 00850047780683		OUT - Est. Axiv Oxymetazoline - Rev. 4 copia_001.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
e67be450-f8e4-4bc1-88bd-1259d379f55fProduct name120210127
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
c53f3286-4062-4cf5-8355-399519c639a6Product name120170424
a993dfc5-f219-4460-bde6-30dd724d9ef0Product name120160818
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82706-03082706-030-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE593YOG76RNIACT
OXYMETAZOLINE HYDROCHLORIDEK89MJ0S5VYACTIB
SODIUM PHOSPHATE DIBASIC DIHYDRATE94255I6E2TIACT
POVIDONE K30U725QWY32XIACT
EDETATE DISODIUM7FLD91C86KIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22026-04-10full-release2026-06-01 01:53:20
12026-02-23monthly-update2026-06-03 17:56:44

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
AXIV Sinus Severe Ultra Fine MistOXYMETAZOLINE HYDROCHLORIDE.VIVUNT PHARMA LLC4b81abf9-3ea7-e996-e063-6394a90a71e82026-06-23WarningsExact identifier
ndc (package): 82706-030-01
ndc (product): 82706-030
ndc11 (package): 82706003001
spl id: 54f03226-1056-8325-e063-6394a90ac888
spl set id: 4b81abf9-3ea7-e996-e063-6394a90a71e8

Reported adverse events (FAERS/openFDA)#

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