Drugplain

Fexofenadine HCL 60 mg/1

Fexofenadine HCL · TABLET · Camber Consumer Care

10 Recalls on Record
Plain English

Fexofenadine HCL is a tablet containing fexofenadine hcl at 60 mg/1, taken oral. Manufactured by Camber Consumer Care.

Key Facts

Brand Name
Fexofenadine HCL
Generic Name
Fexofenadine HCL
NDC Code (Product)
69230-301
Manufacturer
Camber Consumer Care
Strength
60 mg/1
Dosage Form
TABLET
Route
ORAL
Marketing Status
Application #
ANDA204097
Marketing Start
08/19/2016

Recall History

10 Recalls on Record
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 II01/18/2019

Mylan Pharmaceuticals Inc.

Failed Impurities/Degradation Specifications: Related compound results obtained during routine stability testing was slightly elevated above specification.

TerminatedVoluntary: Firm initiated
Class III11/12/2021

Dr. Reddy's Laboratories, Inc.

Failed dissolution specifications

TerminatedN/A
Class III03/11/2015

Mylan Pharmaceuticals Inc.

Failed Impurities/Degradation Specifications: out of specification results for a related compound - a degradant of fexofenadine.

TerminatedVoluntary: Firm initiated
Class III11/12/2021

Dr. Reddy's Laboratories, Inc.

Failed dissolution specifications

TerminatedN/A
Class III11/12/2021

Dr. Reddy's Laboratories, Inc.

Failed dissolution specifications

TerminatedN/A
Class III11/21/2022

Dr. Reddy's Laboratories, Inc.

Failed dissolution specifications

Terminated
Class III01/04/2022

Dr. Reddy's Laboratories, Inc.

Failed Dissolution Specifications

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 ineffective774 reports
nausea460 reports
fatigue424 reports
headache421 reports
diarrhoea418 reports
dizziness384 reports
product quality issue355 reports
pruritus355 reports
dyspnoea353 reports
rash316 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses reduces hives and relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occurring.

Dosage & Administration

Directions adults and children 12 years of age and over: take one 180 mg tablet with water every once a day; do not take more than 1 tablet 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

Severe Allergy Warning: Get emergency help immediately if you have hives along with any of the following symptoms:  trouble swallowing  dizziness or loss of consciousness  swelling of tongue  swelling in or around mouth  trouble speaking  wheezing or problems breathing  drooling These symptoms may be signs of anaphylactic shock. This condition can be life threatening if not treated by a health professional immediately. Symptoms of anaphylactic shock may occur when hives first appear or up to a few hours later

Frequently Asked Questions

What is Fexofenadine HCL used for?

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

Is Fexofenadine HCL a controlled substance?

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

What is the generic name for Fexofenadine HCL?

The generic name for Fexofenadine HCL is Fexofenadine HCL. There are 10 other brand versions of Fexofenadine HCL.

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

The NDC (National Drug Code) for Fexofenadine HCL 60 mg/1 is 69230-301, listed by Camber Consumer Care.