Drug Facts
Active ingredients
- Oxymetazoline HCl 0.05%
Axiv Sinus Severe Ultra Fine Mist Aerosol, Spray
FDA Label NDC 82706-030
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Vivunt Pharma Llc for the product Axiv Sinus Severe Ultra Fine Mist (NDC 82706-030). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, purpose, uses, warnings, when using this product, stop use and ask a doctor, if pregnant or breast-feeding,, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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.
Overdosage
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
- 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.
To Use
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.
Other
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
- 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
MAXIMUM STRENGTH
UP TO 265 SPRAYS
PER 15 ML BOTTLE
Oxymetazoline HCl 0.05%
Nasal Decongestant
0.5 Fl OZ (15 ml)
* Please review the disclaimer below.
