SINUS SEVERE ULTRA FINE MIST- oxymetazoline hydrochloride. aerosol, spray

Sinus Severe Ultra Fine Mist by

Drug Labeling and Warnings

Sinus Severe Ultra Fine Mist by is a Otc medication manufactured, distributed, or labeled by VIVUNT PHARMA LLC, Midas Care Pharmaceuticals Pvt Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

• Oxymetazoline HCl 0.05%

Purpose

• Nasal decongestant

Uses

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

Warnings

Warnings

When using this product

• 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

if symptoms persist.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

Keep out of reach of children.

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

Directions

• 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.

Other information

• Store at room temperature

Inactive ingredients

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

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)

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)

INGREDIENTS AND APPEARANCE

SINUS SEVERE ULTRA FINE MIST 
oxymetazoline hydrochloride. aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82706-026
Route of Administration	NASAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY)	OXYMETAZOLINE HYDROCHLORIDE	0.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
POVIDONE K30 (UNII: U725QWY32X)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82706-026-01	1 in 1 CARTON	01/19/2026
1		15 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	01/19/2026

Labeler - VIVUNT PHARMA LLC (045829437)

Establishment
Name	Address	ID/FEI	Business Operations
Midas Care Pharmaceuticals Pvt Ltd		862273427	manufacture(82706-026) , label(82706-026) , pack(82706-026)