Fluticasone Propionate is an over-the-counter medicine. The sections below reproduce one FDA label for it, named under "Label". Products in other forms, strengths or from other makers have their own labels, which can differ.
- Type
- Over the counter (OTC)
- Brand names
- Childrens Flonase Allergy Relief
- Taken
- Nasal
- Label
- Haleon US Holdings LLC, revised December 19, 2024 · full label on DailyMed
Purpose
Allergy symptom reliever
What it is used for
Temporarily relieves these symptoms of hay fever or other upper respiratory allergies:
- nasal congestion
- itchy nose
- runny nose
- itchy, watery eyes
- sneezing
Active ingredient
Fluticasone propionate (glucocorticoid)* 50 mcg *read the Question & Answer Leaflet
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
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.
Pregnancy or breastfeeding
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.
Dosage:
we do not reproduce dosing instructions. The right dose depends on the person and the condition and is set by the prescriber or pharmacist. Dosage section of the full label.
Fluticasone in the news
We have not covered this medicine yet. Latest news
Recalls
-
Class II Ongoing
Fluticasone Propionate Nasal Spray USP, 50 mcg per spray, 120 metered sprays, 16 g net fill, Rx only, Manufactured by: Apotek Inc., Toronto, Ontario, Cananda, Marketed by: GSMS Incorporated, Camarillo, CA, NDC 60429-195-…
Reason: CGMP Deviations:Suspected potential presence of Burkholderia cepacia complex
Lots, distribution and details
- Product
- Fluticasone Propionate Nasal Spray USP, 50 mcg per spray, 120 metered sprays, 16 g net fill, Rx only, Manufactured by: Apotek Inc., Toronto, Ontario, Cananda, Marketed by: GSMS Incorporated, Camarillo, CA, NDC 60429-195-15
- Lots / codes
- Lot #: TX5275, Exp. Date: 10/31/2026.
- Distribution
- Nationwide in the USA
- Quantity
- 59,712 bottles
- Recall started
- February 14, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0349-2024
-
Class II Ongoing
Fluticasone Propionate Nasal Spray USP 50mcg, 120 Metered Sprays – 16 g net fill, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9, Manufactured for: Apotex Corp Weston, FL 33326. NDC 60505-0829-1
Reason: CGMP Deviations: potential presence of Burkholderia cepacia complex
Lots, distribution and details
- Product
- Fluticasone Propionate Nasal Spray USP 50mcg, 120 Metered Sprays – 16 g net fill, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9, Manufactured for: Apotex Corp Weston, FL 33326. NDC 60505-0829-1
- Lots / codes
- Lot number # TX5274 Exp. 09/30/2026
- Distribution
- Nationwide in the USA
- Quantity
- 292,752 bottles
- Recall started
- February 9, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0326-2024
-
Class II Terminated
Fluticasone Propionate Nasal Spray USP, 50MCG per spray, 16 g net fill weight, 120 Metered Sprays, For Intranasal Use Only, Rx Only, Manufactured for: Apotext Corp., Weston, FL 33326. NDC: 60505-0829-1
Reason: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Lots, distribution and details
- Product
- Fluticasone Propionate Nasal Spray USP, 50MCG per spray, 16 g net fill weight, 120 Metered Sprays, For Intranasal Use Only, Rx Only, Manufactured for: Apotext Corp., Weston, FL 33326. NDC: 60505-0829-1
- Lots / codes
- Batch TE9159, TE8156
- Distribution
- Nationwide USA
- Quantity
- 6 units
- Recall started
- January 26, 2022 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0182-2024
-
Class II Ongoing
Fluticasone Propionate Nasal Spray, 50mcg, 16 g bottles, Manufactured by: HI-TECH PHARMACAL CO., INC., Amiy. ALL NDCs
Reason: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Lots, distribution and details
- Product
- Fluticasone Propionate Nasal Spray, 50mcg, 16 g bottles, Manufactured by: HI-TECH PHARMACAL CO., INC., Amiy. ALL NDCs
- Lots / codes
- All Lots
- Distribution
- Nationwide in the USA and Puerto Rico
- Quantity
- N/A
- Recall started
- April 26, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0804-2023
Have this medicine at home? Compare the lot number and expiry date on your package with the recall. Do not stop taking a prescribed medicine on your own — stopping suddenly can be riskier than the recalled lot. Your pharmacist can check it and usually swap it for an unaffected one.
Get alerts for Fluticasone Propionate
We will email you if the FDA reports a recall, if its shortage status changes, or when we publish news about it — at most one email a day. No account needed.
Source: FDA structured product labeling, retrieved through openFDA. Label text is shown as published by the FDA, without editing; long sections are shortened, marked […]. openFDA data are not validated for clinical use — always check the current label and ask a doctor or pharmacist about your own treatment. Set ID b6134ba0-b70a-4eac-9a82-cef64b242c1d.