allergy relief D12 — Tablet, Film Coated, Extended Release

Overview

Brand name

allergy relief D12

Generic name

Cetirizine hydrochloride, Pseudoephedrine hydrochloride

Dosage form

Tablet, Film Coated, Extended Release

Route

Oral

Marketing category

ANDA · ANDA

Labeler

Walgreen Company

Product type

Human Otc Drug

DEA schedule

Not scheduled

Active ingredients

2

NDC product codes

2

Packages

4

Data completeness

76% 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
Pseudoephedrine Hydrochloride	120 mg/1	1305603	View

Forms, strengths and routes

Source: NDC Directory

Dosage form

Tablet, Film Coated, Extended Release

Route of administration

Oral

Presentations

6

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@FDA NDC 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 20260228). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20260228 HUMAN OTC DRUG · 20260217

Indications and Usage

openFDA Drug Labeling

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 • nasal congestion • reduces swelling of nasal passages • temporarily relieves sinus congestion and pressure • temporarily restores freer breathing through the nose

Purpose

openFDA Drug Labeling

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

openFDA Drug Labeling

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 pregnant 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

openFDA Drug Labeling

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

openFDA Drug Labeling

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

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
51316-607-53	51316-607	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	12 BLISTER PACK in 1 CARTON (51316-607-53) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK	February 20, 2026
51316-607-62	51316-607	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	24 BLISTER PACK in 1 CARTON (51316-607-62) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK	December 10, 2025
0363-4923-53	0363-4923	Walgreen Company	12 BLISTER PACK in 1 CARTON (0363-4923-53) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK	October 20, 2021
0363-4923-62	0363-4923	Walgreen Company	24 BLISTER PACK in 1 CARTON (0363-4923-62) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK	October 20, 2021
51316-607	51316-607	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	—	December 10, 2025
0363-4923	0363-4923	Walgreen Company	—	October 20, 2021

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.