Drugplain

allergy relief d 5 mg/1

cetirizine hydrochloride, pseudoephedrine hydrochloride · TABLET, FILM COATED, EXTENDED RELEASE · Publix Super Markets Inc

10 Recalls on Record
Plain English

allergy relief d is a tablet, film coated, extended release containing cetirizine hydrochloride, pseudoephedrine hydrochloride at 5 mg/1, taken oral. Manufactured by Publix Super Markets Inc.

Key Facts

Brand Name
allergy relief d
Generic Name
cetirizine hydrochloride, pseudoephedrine hydrochloride
NDC Code (Product)
56062-147
Manufacturer
Publix Super Markets Inc
Strength
5 mg/1
Dosage Form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Marketing Status
Application #
ANDA210719
Marketing Start
02/12/2020

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 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 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 III01/04/2022

Dr. Reddy's Laboratories, Inc.

Failed Dissolution Specifications

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 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 III01/04/2022

Dr. Reddy's Laboratories, Inc.

Failed Dissolution Specifications

TerminatedVoluntary: Firm initiated
Class III11/12/2021

Dr. Reddy's Laboratories, Inc.

Failed dissolution specifications

TerminatedN/A

Side Effects Reported to FDA

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

drug ineffective553 reports
abdominal discomfort354 reports
pain347 reports
pemphigus341 reports
rheumatoid arthritis335 reports
alopecia329 reports
systemic lupus erythematosus329 reports
fatigue327 reports
maternal exposure during pregnancy307 reports
glossodynia306 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: sneezing itchy, watery eyes runny nose itching of the nose or throat reduces swelling of nasal passages temporarily relieves sinus congestion and pressure temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies temporarily restores freer breathing through the nose

Dosage & Administration

DIRECTIONS do not divide, crush, chew or dissolve the tablet adults and children 12 years and over 1 tablet daily with a full glass of water; not more than 1 tablet in 24 hours children under 12 years of age ask a doctor consumers with liver or kidney disease ask a doctor

Warnings

WARNINGS Do not use if you have ever had an allergic reaction to this product or any of its ingredients if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have heart disease thyroid disease high blood pressure diabetes trouble urinating due to an enlarged prostate gland liver or kidney disease. Your doctor should determine if you need a different dose. When using this product do not take more than directed. Taking more than directed may cause drowsiness. Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. symptoms do not improve within 7 days or are accompanied by a fever nervousness, dizziness or sleeplessness occurs If pregnant or breast-feeding, Ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Frequently Asked Questions

What is allergy relief d used for?

allergy relief d contains cetirizine hydrochloride, pseudoephedrine hydrochloride. It is a tablet, film coated, extended release taken oral. Consult your doctor for specific uses.

Is allergy relief d a controlled substance?

allergy relief d is not classified as a controlled substance by the DEA.

What is the generic name for allergy relief d?

The generic name for allergy relief d is cetirizine hydrochloride, pseudoephedrine hydrochloride. There are 9 other brand versions of cetirizine hydrochloride, pseudoephedrine hydrochloride.

What is the NDC code for allergy relief d 5 mg/1?

The NDC (National Drug Code) for allergy relief d 5 mg/1 is 56062-147, listed by Publix Super Markets Inc.