380- Health A2Z Nasal Spray

Label at a glance#

Contacts and useful links#

Label contents#

Full prescribing information#

Active ingredient (in each spray)

OTC - ACTIVE INGREDIENT SECTION

Fluticasone propionate (glucocorticoid) 50 mcg 

Purpose

OTC - PURPOSE SECTION

Allergy symptom reliever 

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves these symptoms of hay fever or other upper respiratory allergies:

• runny nose
• sneezing
• itchy, watery eyes
• itchy nose 
• nasal congestion

Warnings

WARNINGS SECTION

Only for use in the nose. Do not spray into your eyes or mouth.

Do not use

OTC - DO NOT USE SECTION

• in children under 4 years of age
• to treat asthma
• if you have an injury or surgery to your nose that is not fully healed
• if you have ever had an allergic reaction to this product or any of the ingredients

Ask a doctor before use if

OTC - ASK DOCTOR SECTION

have or had glaucoma or cataracts.

Ask a doctor or pharmacist before use if you are taking

OTC - ASK DOCTOR/PHARMACIST SECTION

• medicine for HIV infection (such as ritonavir)
• a steroid medicine for asthma, allergies or skin rash
• ketoconazole pills (medicine for fungal infection)

When using this product

OTC - WHEN USING SECTION

• the growth rate of some children may be slower
• stinging or sneezing may occur for a few seconds right after use
• do not share this bottle with anyone else as this may spread germs
• remember to tell your doctor about all the medicines you take, including this one

Stop use and ask a doctor if

OTC - STOP USE SECTION

• you have, or come into contact with someone who has chicken pox, measles, or tuberculosis
• your symptoms do not get better within 7 days of starting use or you get new symptoms such as severe facial pain or thick nasal discharge. You may have something more than allergies, such as an infection.
• you get a constant whistling sound from your nose. This may be a sign of damage inside your nose.
• you get an allergic reaction to this product. Seek medical help right away.
• you get new changes to your vision that develop after starting this product
• you have severe or frequent nosebleeds

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

read the Quick Start Guide for how to:

• prime the bottle
• use the spray
• clean the spray nozzle
  

• shake gently before each use
• use this product only once a day
• do not use more than directed

ADULTS AND CHILDREN 12 YEARS OF AGE AND OLDER

• Week 1: use 2 sprays in each nostril daily
• Week 2 through 6 months: use 1 or 2 sprays in each nostril once daily, as needed to treat symptoms
• After 6 months of daily use: ask a doctor if you can keep using

CHILDREN 4 to 11 YEARS OF AGE

• the growth of some children may be slower while using this product. Children should use for the shortest amount of time necessary to achieve symptom relief. Talk to your child’s doctor if your child needs to use the spray for longer than 2 months a year.
• an adult should supervise use
• use 1 spray in each nostril daily

CHILDREN UNDER 4 YEARS OF AGE

do not use

Other information

SPL UNCLASSIFIED SECTION

• you may start to feel relief the first day and full effect after several days of regular once-a-day use
• store between 4º and 30ºC (39º and 86ºF)
• keep this label and enclosed materials. They contain important additional information.

Inactive ingredients

INACTIVE INGREDIENT SECTION

0.02% w/w benzalkonium chloride, dextrose, microcrystalline cellulose and carboxymethylcellulose sodium, 0.25% w/w phenylethyl alcohol, polysorbate 80, purified water

Questions or comments

OTC - QUESTIONS SECTION

Call 1-888-952-0050

Monday through Friday 9AM - 5PM EST

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Products#

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

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

• Fluticasone Propionate
• FLUTICASONE
• BENZALKONIUM CHLORIDE
• CARBOXYMETHYLCELLULOSE SODIUM
• CELLULOSE, MICROCRYSTALLINE
• DEXTROSE
• PHENYLETHYL ALCOHOL
• POLYSORBATE 80
• WATER

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

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.

Reported adverse events (FAERS/openFDA)#

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