Drugplain

Fexofenadine Hydrochloride 180 mg/1

Fexofenadine Hydrochloride · TABLET · Granules India Ltd

10 Recalls on Record
Plain English

Fexofenadine Hydrochloride is a tablet containing fexofenadine hydrochloride at 180 mg/1, taken oral. Manufactured by Granules India Ltd.

Key Facts

Brand Name
Fexofenadine Hydrochloride
Generic Name
Fexofenadine Hydrochloride
NDC Code (Product)
62207-766
Manufacturer
Granules India Ltd
Strength
180 mg/1
Dosage Form
TABLET
Route
ORAL
Marketing Status
Application #
ANDA211075
Marketing Start
12/18/2020

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

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. There are 11 other brand versions of Fexofenadine Hydrochloride.

What is the NDC code for Fexofenadine Hydrochloride 180 mg/1?

The NDC (National Drug Code) for Fexofenadine Hydrochloride 180 mg/1 is 62207-766, listed by Granules India Ltd.