FDA.reportPublic FDA data

dermveda TM  SINAFLUX ULTRA NATURAL SINUS RELIEF

Manufacturer
Celcius Corp.
Effective date
2026-05-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
monthly-update
Hydrated at
2026-07-17 21:34:12

Label at a glance#

Productdermveda SINAFLUX ULTRA NATURAL SINUS RELIEF
Active ingredientMELALEUCA ALTERNIFOLIA WHOLE, GLYCYRRHIZA GLABRA (LICORICE) ROOT POWDER
Label structure11 sections

Indications and uses

• temporarily relieves nasal congestion due to a cold, or other upper respiratory allergies • temporarily relieves sinus congestion, breathing and pressure. Helps clear nasal passages : shrinks swollen membranes

Dosage and administration

Remove the cap, With your head held upright insert nozzle into each of the nostril and push down the nozzle 2-3 times.

Storage and handling

Store in a cool dry place.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Melaleuca alternifolia 8x HPUS
Glycyrrhiza Glabra 10X HPUS

Purpose

OTC - PURPOSE SECTION

Anti-Microbial
Anti-Inflammatory

Uses

INDICATIONS & USAGE SECTION

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

Helps clear nasal passages :
shrinks swollen membranes

Directions

SPL UNCLASSIFIED SECTION

Remove the cap, With your head held upright insert nozzle into each of the nostril and push down the nozzle 2-3 times.

Warnings

WARNINGS SECTION

The use of this dispenser by more than one person may spread infection
• Avoid spraying in eyes
• Do not exceed recommended dosage
• If pregnant or breast feeding, ask a health professional before use

Do not use • on children under 2 years of age unless directed by a doctor • Avoid contact with eyes.

When using this product
• Mild increase in irritation or burning may occur.

Stop use and ask a doctor if
• Symptoms persist or inflammation increases after weeks of use or if the itch increases.
• Increase in redness on skin.

Pregnant or Breast Feeding
• Ask a Health Professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a poison Control Center right away.

Dosage and Administration

DOSAGE & ADMINISTRATION SECTION

Do Not use on Children less than 2 Years

Adults and children 4 years to under 12 years of age (with adult supervision): Apply up to 4-5 times daily to obtain the desired results. Children under 4 years check with your doctor.

Other information

STORAGE AND HANDLING SECTION

Store in a cool dry place.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Vegetable Glycerin, Chamomile, Quillaja extract, Water

Questions?

OTC - QUESTIONS SECTION

+1-734-726-0148

You may also report serious side effects to this phone number.

Mon-Fri 9:00 AM - 5:00 PM

SPL UNCLASSIFIED SECTION

NASAL MIST

COLD+ALLERGIES

• SOOTHES INFLAMED NASAL PASSAGES.

• CALMS ALLERGY-PRONE NASAL TISSUES.

• EASES STUFFY, BLOCKED NOSE.

• RELIEVES NASAL IRRITATION AND DISCOMFORT.

• SUPPORTS CLEARER, EASIER BREATHING.

ADVANCED BOTANICALS:
• GLYCEROL
• LICORICE
• CHAMOMILE

FAST RELIEF

HOMEOPATHIC MEDICINE

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ULTRA NATURAL SINUS RELIEFULTRA NATURAL SINUS RELIEF

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83819-60883819-608-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
MELALEUCA ALTERNIFOLIA WHOLE976KV4FXYFACTIB
GLYCYRRHIZA GLABRA (LICORICE) ROOT POWDER2788Z9758HACTIB
GLYCERINPDC6A3C0OXIACT
CHAMOMILEFGL3685T2XIACT
QUILLAJA SAPONARIA BARK8N0K3807ZWIACT
WATER059QF0KO0RIACT

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
dermveda SINAFLUX ULTRA NATURAL SINUS RELIEFMELALEUCA ALTERNIFOLIA, GLYCYRRHIZA GLABRACelcius Corp.2b22b08b-83cf-464c-97ab-7e858fc4e3f02026-05-05WarningsExact identifier
ndc (package): 83819-608-03
ndc (product): 83819-608
ndc11 (package): 83819060803
spl id: 6dc592df-ae5b-4685-bd42-fde9abd99d46
spl set id: 2b22b08b-83cf-464c-97ab-7e858fc4e3f0

Reported adverse events (FAERS/openFDA)#

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