NDC 0135-0582 Childrens Flonase Allergy Relief

NDC Product Code 0135-0582

NDC 0135-0582-01

Package Description: 1 BOTTLE in 1 PACKAGE > 60 SPRAY, METERED in 1 BOTTLE

NDC 0135-0582-02

Package Description: 2 BOTTLE in 1 PACKAGE > 60 SPRAY, METERED in 1 BOTTLE

NDC 0135-0582-03

Package Description: 1 BOTTLE in 1 CARTON > 30 SPRAY, METERED in 1 BOTTLE

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Childrens Flonase Allergy Relief with NDC 0135-0582 is a product labeled by Glaxosmithkline Consumer Healthcare Holdings (us) Llc. The generic name of Childrens Flonase Allergy Relief is . The product's dosage form is and is administered via form.

Labeler Name: Glaxosmithkline Consumer Healthcare Holdings (us) Llc

Dosage Form: -

Product Type: What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
  • DEXTROSE (UNII: IY9XDZ35W2)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • WATER (UNII: 059QF0KO0R)
  • CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Glaxosmithkline Consumer Healthcare Holdings (us) Llc
Labeler Code: 0135
Start Marketing Date: 02-29-2016 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2018 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: I What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Information for Patients

Fluticasone Nasal Spray

Fluticasone Nasal Spray is pronounced as (floo tik' a sone)

Why is fluticasone nasal spray medication prescribed?
Fluticasone nasal spray is used to relieve sneezing, runny, stuffy, or itchy nose and itchy, watery eyes caused by hay fever or other allergies (caused by an allergy to p...
[Read More]

* Please review the disclaimer below.

Childrens Flonase Allergy Relief Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredient (In Each Spray)

Fluticasone propionate (glucocorticold) 50 mcg

Purpose

Allergy symptom reliever

Uses

  • Temporarily relieves these symptoms of hay fever or other upper respiratory allergies: •nasal congestion •runny nose •sneezing •itchy nose •itchy, watery eyes

Warnings

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

Do Not Use

  • •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 You

Have or had glaucoma or cataracts

Ask A Doctor Or Pharmacist Before Use If You Are Taking

  • •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

  • •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

  • •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,

Ask a health professional before use.

Keep Out Of Reach Of Children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

  • •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 directedADULTS AND CHILDREN 12 YEARS OF AGE AND OLDER •Week 1- use 2 sprays in each nostril once daily •Week 2 through 6 months- use 1 or 2 sprays in each nostril once daily, as needed to treat your symptoms •After 6 months of daily use – ask your doctor if you can keep usingCHILDREN 4 TO 11 YEARS OF AGE •the growth rate 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 two months a year. •an adult should supervise use •use 1 spray in each nostril once dailyCHILDREN UNDER 4 YEARS OF AGE •do not use

Other Information

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

Inactive Ingredients

Benzalkonium chloride, dextrose, microcrystalline cellulose, phenylethylalcohol, polysorbate 80, purified water, sodium carboxymethylcellulose

* Please review the disclaimer below.