FDA.reportPublic FDA data

Sinus Severe Nasal Spray

Manufacturer
VIVUNT PHARMA LLC | Midas Care Pharmaceuticals Pvt Ltd
Effective date
2026-01-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:34:55

Label at a glance#

ProductSinus 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, Sodium Phosphate monobasic, Edetate disodium, Propylene Glycol, Polyvinylpyrrolidone, Sodium Phosphate dibasic, Purified Water.

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

ULTRA FINE MIST

  • Fast & Powerfull Congestion Relief
  • Nasal Decongestant

MAXIMUM STRENGTH

UP TO 265 SPRAYS

PER 15 ML BOTTLE

Oxymetazoline HCl 0.05%

Nasal Decongestant

0.5 Fl OZ (15ml)

Principal Display PanelPrincipal Display Panel

InnerInner

axiv®

Sinus SEVERE

ULTRA FINE MIST

  • Fast & Powerfull Congestion Relief
  • Nasal Decongestant

MAXIMUM STRENGTH

UP TO 265 SPRAYS

PER 15 ML BOTTLE

Oxymetazoline HCl 0.05%

Nasal Decongestant

0.5 Fl OZ (15 ml)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1000990oxymetazoline HCl 0.05 % Nasal SprayPSN1
1000990oxymetazoline hydrochloride 0.5 MG/ML Nasal SpraySCD1
1000990oxymetazoline hydrochloride 0.05 % Nasal SpraySY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
OXYMETAZOLINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

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		Estuche Axiv Oxymetazoline - Rev. 1_001.jpg

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82706-026-01Sinus Severe Ultra Fine Mist15 mL in 1 BOTTLE, SPRAYAEROSOL, SPRAY151
82706-026-01Sinus Severe Ultra Fine Mist1 in 1 CARTONAEROSOL, SPRAY11

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82706-02682706-026-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
OXYMETAZOLINE HYDROCHLORIDEK89MJ0S5VYACTIB
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FIACT
POVIDONE K30U725QWY32XIACT
EDETATE DISODIUM7FLD91C86KIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUSKH7I04HPUUIACT

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
Sinus Severe Ultra Fine MistOXYMETAZOLINE HYDROCHLORIDE.VIVUNT PHARMA LLC48bf7422-38ef-d4b4-e063-6294a90aa3ab2026-01-19WarningsExact identifier
ndc (package): 82706-026-01
ndc (product): 82706-026
ndc11 (package): 82706002601
spl id: 48bf7422-38f0-d4b4-e063-6294a90aa3ab
spl set id: 48bf7422-38ef-d4b4-e063-6294a90aa3ab

Reported adverse events (FAERS/openFDA)#

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