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allergy relief d

cetirizine hydrochloride, pseudoephedrine hydrochloride · Tablet, Film Coated, Extended Release

Over-the-counter ANDA Official labelling
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
allergy relief d
Generic name
cetirizine hydrochloride, pseudoephedrine hydrochloride
Dosage form
Tablet, Film Coated, Extended Release
Route
Oral
Marketing category
ANDA · ANDA
Labeler
Publix Super Markets Inc
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
4
NDC product codes
6
Packages
11
Data completeness
82% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Cetirizine Hydrochloride 5 mg/1 1014678 View
Loratadine 5 mg/1 311372 View
Pseudoephedrine Hydrochloride 120 mg/1 1305603 View
Pseudoephedrine Sulfate 120 mg/1 1117562 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet, Film Coated, Extended Release
Route of administration
Oral
Presentations
17

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Adrenergic alpha-Agonists [MoA] MoA All 85 members
Histamine H1 Receptor Antagonists [MoA] MoA All 136 members
Histamine-1 Receptor Antagonist [EPC] EPC All 134 members
alpha-Adrenergic Agonist [EPC] EPC All 85 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
210719
Application type
ANDA · Abbreviated New Drug Application
Approval date
November 16, 2018
Sponsor
PPI-DAC
Products on application
1
Submissions recorded
1
Products approved under application 210719.
Product Trade name Form Strength Ingredient Status TE Flags
210719-001 CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, EXTENDED RELEASE CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE Over-the-counter —

Approval history

Source: Drugs@FDA
Most recent submissions on application 210719.
Type No. Action Status Date Review
Original application 1 Approved November 16, 2018 Standard

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20250212). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20250212 HUMAN OTC DRUG · 20201019

Indications and Usage

openFDA Drug Labeling

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 • 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

Purpose Antihistamine Nasal decongestant

Dosage and Administration

openFDA Drug Labeling

Directions • do not break or chew tablet; swallow tablet whole adults and children 12 years and over take 1 tablet every 12 hours; do not take more than 2 tablets in 24 hours. adults 65 years and over ask a doctor children under 12 years of age ask a doctor consumers with liver or kidney disease ask a doctor

Warnings Do not use • if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine. • 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 • diabetes • glaucoma • high blood pressure • trouble urinating due to an enlarged prostate gland • liver or kidney disease. Your doctor should determine if you need a different dose. Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives. When using this product • do not use more than directed • drowsiness may occur • avoid alcoholic drinks • alcohol, sedatives, and tranquilizers may increase drowsiness • be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if • an allergic reaction to this product occurs. Seek medical help right away. • you get nervous, dizzy, or sleepless • symptoms do not improve within 7 days or are accompanied by fever If pregnancy or breast-feeding: • if breast-feeding: not recommended • if pregnant: 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)

Do not use • if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine. • 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

openFDA Drug Labeling

Ask a doctor before use if you have • heart disease • thyroid disease • diabetes • glaucoma • high blood pressure • trouble urinating due to an enlarged prostate gland • liver or kidney disease. Your doctor should determine if you need a different dose.

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

Active Ingredient

openFDA Drug Labeling

Active ingredients (in each extended release tablet) Cetirizine HCl 5 mg Pseudoephedrine HCl 120 mg

Adverse event reports

Source: openFDA FAERS
166,303
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: CETIRIZINE HYDROCHLORIDE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
69842-415-53 69842-415 CVS Pharmacy 12 BLISTER PACK in 1 CARTON (69842-415-53) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK April 1, 2020
69842-415-62 69842-415 CVS Pharmacy 24 BLISTER PACK in 1 CARTON (69842-415-62) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK April 1, 2020
37808-651-53 37808-651 H E B 12 BLISTER PACK in 1 CARTON (37808-651-53) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK February 24, 2021
37808-651-62 37808-651 H E B 24 BLISTER PACK in 1 CARTON (37808-651-62) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK February 18, 2021
41250-954-60 41250-954 Meijer Distribution Inc 20 BLISTER PACK in 1 CARTON (41250-954-60) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK June 12, 2018
56062-147-53 56062-147 Publix Super Markets Inc 12 BLISTER PACK in 1 CARTON (56062-147-53) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK February 12, 2021
56062-147-62 56062-147 Publix Super Markets Inc 24 BLISTER PACK in 1 CARTON (56062-147-62) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK February 16, 2021
56062-555-46 56062-555 Publix Super Markets Inc 10 BLISTER PACK in 1 CARTON (56062-555-46) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK April 23, 2018
56062-555-60 56062-555 Publix Super Markets Inc 20 BLISTER PACK in 1 CARTON (56062-555-60) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK April 23, 2018
11822-1055-0 11822-1055 Rite Aid Corporation 10 BLISTER PACK in 1 CARTON (11822-1055-0) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK May 5, 2020
11822-1055-1 11822-1055 Rite Aid Corporation 30 BLISTER PACK in 1 CARTON (11822-1055-1) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK December 21, 2022
69842-415 69842-415 CVS Pharmacy — April 1, 2020
37808-651 37808-651 H E B — February 18, 2021
41250-954 41250-954 Meijer Distribution Inc — June 12, 2018
56062-147 56062-147 Publix Super Markets Inc — February 12, 2020
56062-555 56062-555 Publix Super Markets Inc — April 23, 2018
11822-1055 11822-1055 Rite Aid Corporation — May 5, 2020

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Drug Labeling FDA / NLM Prescribing information reproduced above
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 10 sections on this page.