NDC 0135-0615 Flonase Sensimist Allergy Relief

Fluticasone Furoate

NDC Product Code 0135-0615

NDC CODE: 0135-0615

Proprietary Name: Flonase Sensimist Allergy Relief What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Fluticasone Furoate What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • Fluticasone is used to control and prevent symptoms (such as wheezing and shortness of breath) caused by asthma. Controlling symptoms of asthma helps you maintain your normal activities and decreases time lost from work or school. Fluticasone belongs to a class of drugs known as corticosteroids. It works by reducing swelling (inflammation) of the airways in the lungs to make breathing easier. This medication must be used regularly to be effective. It does not work right away and should not be used to relieve sudden asthma attacks. If an asthma attack occurs, use your quick-relief inhaler (such as albuterol, also called salbutamol in some countries) as prescribed.

NDC Code Structure

NDC 0135-0615-01

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

NDC 0135-0615-02

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

NDC 0135-0615-03

Package Description: 1 BOTTLE in 1 PACKAGE > 120 SPRAY, METERED in 1 BOTTLE

NDC 0135-0615-04

Package Description: 3 BOTTLE in 1 PACKAGE > 120 SPRAY, METERED in 1 BOTTLE

NDC 0135-0615-05

Package Description: 2 BOTTLE in 1 PACKAGE > 120 SPRAY, METERED in 1 BOTTLE

NDC 0135-0615-06

Package Description: 1 BOTTLE in 1 PACKAGE > 72 SPRAY, METERED in 1 BOTTLE

NDC Product Information

Flonase Sensimist Allergy Relief with NDC 0135-0615 is a a human over the counter drug product labeled by Glaxosmithkline Consumer Healthcare Holdings (us) Llc. The generic name of Flonase Sensimist Allergy Relief is fluticasone furoate. The product's dosage form is spray, metered and is administered via nasal form.

Labeler Name: Glaxosmithkline Consumer Healthcare Holdings (us) Llc

Dosage Form: Spray, Metered - A non-pressurized dosage form consisting of valves which allow the dispensing of a specified quantity of spray upon each activation.

Product Type: Human Otc Drug 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.

Flonase Sensimist Allergy Relief Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • FLUTICASONE FUROATE 27.5 ug/1

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)
  • CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
  • ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • WATER (UNII: 059QF0KO0R)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Nasal - Administration to the nose; administered by way of the nose.
  • Nasal - Administration to the nose; administered by way of the nose.

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
FDA Application Number: NDA022051 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: NDA - A product marketed under an approved New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 02-01-2017 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: 12-31-2020 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: N 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’.

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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]

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Flonase Sensimist 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 furoate 27.5 mcg (glucocorticold)**read the Question & Answer Book

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 (for ages 12 and older)

Warnings

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

Do Not Use

  • •in children under 2 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: •shake vigorously before each use •prime the bottle •use the spray •sniff gently after each spray •clean the spray nozzle with a clean dry tissue •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 2 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 2 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 15° and 30°C (59° and 86°F) •do not refrigerate or freeze •keep this label and enclosed materials. They contain important additional information.

Inactive Ingredients

Benzalkonium chloride, carboxymethylcellulose sodium, dextrose anhydrous, edentate disodium, microcrystalline cellulose, polysorbate 80, purified water

* Please review the disclaimer below.