Drugplain

Allergy Relief 60 mg/1

Fexofenadine Hydrochloride 60 mg · TABLET · Rite Aid Corporation

10 Recalls on Record
Plain English

Allergy Relief is a tablet containing fexofenadine hydrochloride 60 mg at 60 mg/1, taken oral. Manufactured by Rite Aid Corporation.

Key Facts

Brand Name
Allergy Relief
Generic Name
Fexofenadine Hydrochloride 60 mg
NDC Code (Product)
11822-9995
Manufacturer
Rite Aid Corporation
Strength
60 mg/1
Dosage Form
TABLET
Route
ORAL
Marketing Status
Application #
ANDA076502
Marketing Start
12/01/2021

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 ineffective27,596 reports
fatigue23,306 reports
pain19,305 reports
off label use18,404 reports
headache17,809 reports
nausea16,755 reports
dyspnoea16,587 reports
rash14,262 reports
diarrhoea14,014 reports
arthralgia12,990 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?

Allergy Relief contains Fexofenadine Hydrochloride 60 mg. It is a tablet taken oral. Consult your doctor for specific uses.

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 Fexofenadine Hydrochloride 60 mg. There are 1 other brand versions of Fexofenadine Hydrochloride 60 mg.

What is the NDC code for Allergy Relief 60 mg/1?

The NDC (National Drug Code) for Allergy Relief 60 mg/1 is 11822-9995, listed by Rite Aid Corporation.

Product NDC

11822-9995

Package NDC

11822-9995-1

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

Data from openFDA · Public domain (CC0 1.0)