Drugplain

Fexofenadine Hydrochloride 60 mg/1

Fexofenadine Hydrochloride 60 mg · TABLET · Kroger Company

10 Recalls on Record
Plain English

Fexofenadine hydrochloride is an antihistamine tablet taken by mouth that is available over-the-counter to relieve allergy symptoms such as sneezing, runny nose, and itchy eyes. This 60 mg tablet works by blocking histamine in the body to reduce allergic reactions without causing significant drowsiness.

Key Facts

Brand Name
Fexofenadine Hydrochloride
Generic Name
Fexofenadine Hydrochloride 60 mg
NDC Code (Product)
30142-091
Manufacturer
Kroger Company
Strength
60 mg/1
Dosage Form
TABLET
Route
ORAL
Marketing Status
Application #
ANDA076502
Marketing Start
01/03/2022

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 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 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 II08/23/2019

Aurolife Pharma, LLC

Failed Impurities/Degradation Specifications

TerminatedVoluntary: Firm initiated
Class II08/23/2019

Aurolife Pharma, LLC

Failed Impurities/Degradation Specifications

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 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 II08/23/2019

Aurolife Pharma, LLC

Failed Impurities/Degradation Specifications

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

drug ineffective780 reports
nausea461 reports
fatigue423 reports
headache423 reports
diarrhoea418 reports
dizziness387 reports
product quality issue363 reports
pruritus357 reports
dyspnoea353 reports
rash316 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 upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies reduces swelling of nasal passages temporarily relieves sinus congestion and pressure temporarily restores freer breathing through the nose

Dosage & Administration

Directions do not divide, crush, chew or dissolve the tablet; swallow tablet whole adults and children 12 years of age and over take 1 tablet with a glass of water every 12 hours on an empty stomach; do not take more than 2 tablets in 24 hours children under 12 years of age do not use adults 65 years of age and older ask a doctor consumers with kidney disease ask a doctor

Warnings

Warnings

Frequently Asked Questions

What is Fexofenadine Hydrochloride used for?

Fexofenadine hydrochloride is an antihistamine tablet taken by mouth that is available over-the-counter to relieve allergy symptoms such as sneezing, runny nose, and itchy eyes. This 60 mg tablet works by blocking histamine in the body to reduce allergic reactions without causing significant drowsiness.

Is Fexofenadine Hydrochloride a controlled substance?

Fexofenadine Hydrochloride is not classified as a controlled substance by the DEA.

What is the generic name for Fexofenadine Hydrochloride?

The generic name for Fexofenadine Hydrochloride is Fexofenadine Hydrochloride 60 mg. There are 3 other brand versions of Fexofenadine Hydrochloride 60 mg.

What is the NDC code for Fexofenadine Hydrochloride 60 mg/1?

The NDC (National Drug Code) for Fexofenadine Hydrochloride 60 mg/1 is 30142-091, listed by Kroger Company.

Product NDC

30142-091

Package NDC

30142-091-12

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

Data from openFDA · Public domain (CC0 1.0)