FDA Label for Sinus Severe Ultra Fine Mist

View Indications, Usage & Precautions

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.
OVERDOSAGE
DIRECTIONS
OTHER INFORMATION
INACTIVE INGREDIENTS
OTHER
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sinus Severe Ultra Fine Mist Product Label

The following document was submitted to the FDA by the labeler of this product Vivunt Pharma Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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

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

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.

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

MAXIMUM STRENGTH

UP TO 265 SPRAYS

PER 15 ML BOTTLE

Oxymetazoline HCl 0.05%

Nasal Decongestant

0.5 Fl OZ (15ml)