Sinus Severe Nasal Spray

Sinus Severe Nasal Spray
SPL v1
SPL
SPL Set ID 48bf7422-38ef-d4b4-e063-6294a90aa3ab
Route
NASAL
Published
Effective Date 2026-01-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Oxymetazoline (0.5 mg)
Inactive Ingredients
Sodium Phosphate, Dibasic, Anhydrous Povidone K30 Edetate Disodium Propylene Glycol Water Benzalkonium Chloride Sodium Phosphate, Monobasic, Anhydrous

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2026-01-19

Description

Active ingredients Oxymetazoline HCl 0.05%

Purpose

Nasal decongestant


Medication Information

Purpose
  • Nasal decongestant
Description

Active ingredients Oxymetazoline HCl 0.05%

Uses
  • temporarily relieves nasal congestion due to a cold
  • hay fever or other upper respiratory allergies
  • sinus congestion and pressure.
Section 34088-5

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

Section 42229-5

Distributed by: VIVUNT PHARMA LLC

8950 SW 74th Court, Suite 1901

Miami, FL 33156-3178. USA.

Product from India.

www.vivunt.live

Section 51945-4

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)

Warnings

Warnings

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.

Drug Facts

Active ingredients

  • Oxymetazoline HCl 0.05%
Other Information
  • Store at room temperature
Inactive Ingredients

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

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.


Structured Label Content

Uses
  • temporarily relieves nasal congestion due to a cold
  • hay fever or other upper respiratory allergies
  • sinus congestion and pressure.
Section 34088-5 (34088-5)

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

Section 42229-5 (42229-5)

Distributed by: VIVUNT PHARMA LLC

8950 SW 74th Court, Suite 1901

Miami, FL 33156-3178. USA.

Product from India.

www.vivunt.live

Section 51945-4 (51945-4)

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)

Purpose
  • Nasal decongestant
Warnings

Warnings

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.

Drug Facts

Active ingredients

  • Oxymetazoline HCl 0.05%
Other Information (Other information)
  • Store at room temperature
Inactive Ingredients (Inactive ingredients)

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

When Using This Product (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 (Stop use and ask a doctor)

if symptoms persist.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

Keep out of reach of children.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)