Drugplain

ALLERGY RELIEF 50 ug/1

Fluticasone propionate · SPRAY, METERED · CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED

10 Recalls on RecordCurrently in Shortage
Plain English

Fluticasone propionate nasal spray is used to relieve allergy symptoms such as sneezing, itching, and nasal congestion. This steroid medication is available over-the-counter and works by reducing inflammation in the nasal passages.

Key Facts

Brand Name
ALLERGY RELIEF
Generic Name
Fluticasone propionate
NDC Code (Product)
51316-497
Manufacturer
CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Strength
50 ug/1
Dosage Form
SPRAY, METERED
Route
NASAL
Marketing Status
Application #
ANDA207957
Marketing Start
12/16/2025

Recall History

10 Recalls on Record
Class II07/27/2021

Perrigo Company PLC

Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.

TerminatedVoluntary: Firm initiated
Class II06/05/2019

Sun Pharmaceutical Industries, Inc.

Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: elevated substance results that were reported above or near the specification limit

TerminatedVoluntary: Firm initiated
Class II02/09/2023

L. Perrigo Company

Failed Impurities/Degradation Specifications

TerminatedVoluntary: Firm initiated
Class II02/09/2023

L. Perrigo Company

Failed Impurities/Degradation Specifications

TerminatedVoluntary: Firm initiated
Class II02/07/2014

Ohm Laboratories, Inc.

Defective Container: An unacceptable level of blister defects have been identified in Loratadine and Pseudoephedrine Sulfate Extended Release Tablets, 10 mg/240 mg.

TerminatedVoluntary: Firm initiated
Class II07/27/2021

Perrigo Company PLC

Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.

TerminatedVoluntary: Firm initiated
Class II06/05/2019

P & L Developments, LLC

cGMP Deviations: Firm was notified by their supplier of Cetirizine HCL Oral Solution, USP, 1mg/mL, 4oz, of the voluntary recall that they have initiated due to potential contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

TerminatedVoluntary: Firm initiated
Class II07/27/2021

Perrigo Company PLC

Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.

TerminatedVoluntary: Firm initiated
Class II07/27/2021

Perrigo Company PLC

Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.

TerminatedVoluntary: Firm initiated
Class III11/21/2022

Dr. Reddy's Laboratories, Inc.

Failed dissolution specifications

Terminated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective27,594 reports
fatigue23,305 reports
pain19,303 reports
off label use18,402 reports
headache17,808 reports
nausea16,756 reports
dyspnoea16,584 reports
rash14,262 reports
diarrhoea14,015 reports
arthralgia12,989 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses temporarily relieves these symptoms due to hay fever or other respiratory allergies: ■ sneezing ■ itching of the nose or throat ■ runny nose ■ itchy watery eyes ■temporarily relieves these symptoms due to the common cold: ■ sneezing ■ runny nose

Dosage & Administration

Directions ■ if needed, take every 4-6 hours ■ do not take more than 6 doses in 24-hours children under 4 years of age Do not use children 4 to under 6 years of age Do not use unless directed by a doctor children 6 to under 12 years of age 1 to 2 teaspoonfuls (5 ml to 10 ml)

Warnings

Warnings Do not use ■ with any other product containing diphenhydramine, even one used on skin ■ to make a child sleepy Ask a doctor before use if the child has ■ glaucoma ■ a breathing problem such as chronic bronchitis

Frequently Asked Questions

What is ALLERGY RELIEF used for?

Fluticasone propionate nasal spray is used to relieve allergy symptoms such as sneezing, itching, and nasal congestion. This steroid medication is available over-the-counter and works by reducing inflammation in the nasal passages.

Is ALLERGY RELIEF a controlled substance?

ALLERGY RELIEF is not classified as a controlled substance by the DEA.

What is the generic name for ALLERGY RELIEF?

The generic name for ALLERGY RELIEF is Fluticasone propionate. There are 12 other brand versions of Fluticasone propionate.

What is the NDC code for ALLERGY RELIEF 50 ug/1?

The NDC (National Drug Code) for ALLERGY RELIEF 50 ug/1 is 51316-497, listed by CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED.