Drugplain

Allergy 50 ug/1

mometasone furoate monohydrate · SPRAY, METERED · Rite Aid Corporation

10 Recalls on Record
Plain English

Allergy is a nasal spray containing mometasone furoate, a corticosteroid used to relieve allergy symptoms such as congestion, sneezing, and itching. This medication is available over-the-counter and works by reducing inflammation in the nasal passages.

Key Facts

Brand Name
Allergy
Generic Name
mometasone furoate monohydrate
NDC Code (Product)
11822-7099
Manufacturer
Rite Aid Corporation
Strength
50 ug/1
Dosage Form
SPRAY, METERED
Route
NASAL
Marketing Status
Application #
NDA215712
Marketing Start
03/06/2024

Recall History

10 Recalls on Record
Class II08/03/2018

Product Quest Manufacturing LLC

CGMP Deviations: products manufactured under conditions that could impact its product quality.

TerminatedVoluntary: Firm initiated
Class II08/20/2021

Washington Homeopathic Products, Inc.

Out-of-specification test results obtained for identification testing based on HPTLC analysis.

TerminatedVoluntary: Firm initiated
Class I12/12/2025

Medinatura New Mexico, inc.

Microbial Contamination of Non-Sterile Products: The products have been found to contain yeast/mold and microbial contamination identified as Achromobacter.

OngoingVoluntary: Firm initiated
Class II08/30/2017

Mid Valley Pharmaceutical

CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.

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

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 III01/04/2022

Dr. Reddy's Laboratories, Inc.

Failed Dissolution Specifications

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 II06/29/2022

Mckesson Medical-Surgical Inc. Corporate Office

CGMP Deviations: products were stored outside the drug label specifications.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

drug ineffective42,850 reports
fatigue27,553 reports
pain21,715 reports
off label use21,662 reports
headache21,609 reports
nausea20,472 reports
dyspnoea19,321 reports
diarrhoea16,832 reports
rash16,578 reports
dizziness14,866 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 used for?

Allergy is a nasal spray containing mometasone furoate, a corticosteroid used to relieve allergy symptoms such as congestion, sneezing, and itching. This medication is available over-the-counter and works by reducing inflammation in the nasal passages.

Is Allergy a controlled substance?

Allergy is not classified as a controlled substance by the DEA.

What is the generic name for Allergy?

The generic name for Allergy is mometasone furoate monohydrate. There are 7 other brand versions of mometasone furoate monohydrate.

What is the NDC code for Allergy 50 ug/1?

The NDC (National Drug Code) for Allergy 50 ug/1 is 11822-7099, listed by Rite Aid Corporation.

Product NDC

11822-7099

Package NDC

11822-7099-0

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)