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Childrens Zyrtec

Cetirizine hydrochloride · Tablet, Chewable

Over-the-counter NDA RLD 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
Childrens Zyrtec
Generic name
Cetirizine hydrochloride
Dosage form
Tablet, Chewable
Route
Oral
Marketing category
NDA · NDA
Labeler
Kenvue Brands LLC
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
2
NDC product codes
4
Packages
9
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 10 mg/1 1014678 View
Cetirizine Hydrochloride 2.5 mg/1 1014678 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet, Chewable
Route of administration
Oral
Presentations
13

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
Histamine H1 Receptor Antagonists [MoA] MoA All 136 members
Histamine-1 Receptor Antagonist [EPC] EPC All 134 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
021621
Application type
NDA · New Drug Application
Approval date
March 16, 2004
Sponsor
KENVUE BRANDS
Products on application
5
Submissions recorded
6
Products approved under application 021621.
Product Trade name Form Strength Ingredient Status TE Flags
021621-003 CHILDREN'S ZYRTEC ALLERGY TABLET, CHEWABLE CETIRIZINE HYDROCHLORIDE Discontinued — RLD
021621-004 CHILDREN'S ZYRTEC ALLERGY TABLET, CHEWABLE CETIRIZINE HYDROCHLORIDE Over-the-counter — RLD
021621-005 CHILDREN'S ZYRTEC HIVES RELIEF TABLET, CHEWABLE CETIRIZINE HYDROCHLORIDE Discontinued — RLD
021621-006 CHILDREN'S ZYRTEC HIVES RELIEF TABLET, CHEWABLE CETIRIZINE HYDROCHLORIDE Discontinued — RLD
021621-007 CHILDREN'S ZYRTEC ALLERGY TABLET, CHEWABLE CETIRIZINE HYDROCHLORIDE Over-the-counter — RLD

Therapeutic equivalence

Source: Orange Book
TE code
—
Reference Listed Drug
Yes
Reference Standard
No

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Approval history

Source: Drugs@FDA
Most recent submissions on application 021621.
Type No. Action Status Date Review
Supplement 18 Labeling Approved March 24, 2026 Standard
Supplement 17 Labeling Approved August 15, 2024 Standard
Supplement 12 Labeling Approved December 14, 2021 Standard
Supplement 10 Manufacturing (CMC) Approved November 30, 2020 Standard
Supplement 5 Efficacy Approved November 16, 2007 Unknown
Original application 1 Type 3 - New Dosage Form Approved March 16, 2004 Standard

Review documents

  • 0 · Supplement · March 27, 2026
  • 0 · Supplement · March 27, 2026
  • 0 · Supplement · August 16, 2024
  • 0 · Supplement · August 16, 2024
  • 0 · Supplement · December 16, 2021
  • 0 · Supplement · December 16, 2021
  • 0 · Supplement · January 19, 2021
  • 0 · Supplement · January 19, 2021
  • 0 · Supplement · May 21, 2008
  • 0 · Supplement · November 19, 2007
  • 0 · Original application · December 7, 2004
  • 0 · Original application · March 19, 2004

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260422). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20260422 HUMAN OTC DRUG · 20250408 HUMAN OTC DRUG · 20250407

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

Purpose

openFDA Drug Labeling

Purpose Antihistamine

Dosage and Administration

openFDA Drug Labeling

Directions may be taken with or without water chew or crush tablets completely before swallowing children 2 to under 6 years of age Chew and swallow 1 tablet (2.5 mg) once daily; If needed, dose can be increased to a maximum of 2 tablets (5 mg) once daily or 1 tablet (2.5 mg) every 12 hours. Do not give more than 2 tablets (5 mg) in 24 hours. adults and children 6 years and over Chew and swallow 2 tablets (5 mg) or 4 tablets (10 mg) once daily depending upon severity of symptoms; do not take more than 4 tablets (10 mg) in 24 hours. adults 65 years and over Chew and swallow 2 tablets (5 mg) once daily; do not take more than 2 tablets (5 mg) in 24 hours. children under 2 years of age ask a doctor consumers with liver or kidney disease ask a doctor

Warnings

openFDA Drug Labeling

Warnings 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. Ask a doctor before use if you have 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 drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery in rare cases, you may experience itching after stopping cetirizine. Consult your healthcare provider if this happens. Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. 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.

Ask a Doctor

openFDA Drug Labeling

Ask a doctor before use if you have 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.

Active Ingredient

openFDA Drug Labeling

Active ingredient (in each chewable tablet) Cetirizine HCl 2.5 mg

How Supplied / Storage and Handling

openFDA Drug Labeling

HOW SUPPLIED Product: 50090-6845 NDC: 50090-6845-0 6 TABLET, CHEWABLE in a BLISTER PACK / 4 in a CARTON

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
50090-6781-0 50090-6781 A-S Medication Solutions 4 BLISTER PACK in 1 CARTON (50090-6781-0) / 6 TABLET, CHEWABLE in 1 BLISTER PACK October 26, 2023
50090-6845-0 50090-6845 A-S Medication Solutions 4 BLISTER PACK in 1 CARTON (50090-6845-0) / 6 TABLET, CHEWABLE in 1 BLISTER PACK November 29, 2023
50580-790-01 50580-790 Kenvue Brands LLC 2 BLISTER PACK in 1 CARTON (50580-790-01) / 6 TABLET, CHEWABLE in 1 BLISTER PACK June 21, 2021
50580-790-02 50580-790 Kenvue Brands LLC 4 BLISTER PACK in 1 CARTON (50580-790-02) / 6 TABLET, CHEWABLE in 1 BLISTER PACK June 21, 2021
50580-790-03 50580-790 Kenvue Brands LLC 1 BLISTER PACK in 1 CARTON (50580-790-03) / 6 TABLET, CHEWABLE in 1 BLISTER PACK September 1, 2022
50580-791-01 50580-791 Kenvue Brands LLC 4 BLISTER PACK in 1 CARTON (50580-791-01) / 6 TABLET, CHEWABLE in 1 BLISTER PACK June 21, 2021
50580-791-02 50580-791 Kenvue Brands LLC 8 BLISTER PACK in 1 CARTON (50580-791-02) / 6 TABLET, CHEWABLE in 1 BLISTER PACK January 1, 2023
50580-791-03 50580-791 Kenvue Brands LLC 1 BLISTER PACK in 1 CARTON (50580-791-03) / 6 TABLET, CHEWABLE in 1 BLISTER PACK September 1, 2022
50580-791-72 50580-791 Kenvue Brands LLC 3 BLISTER PACK in 1 CARTON (50580-791-72) / 24 TABLET, CHEWABLE in 1 BLISTER PACK January 15, 2024
50090-6781 50090-6781 A-S Medication Solutions — June 21, 2021
50090-6845 50090-6845 A-S Medication Solutions — June 21, 2021
50580-790 50580-790 Kenvue Brands LLC — June 21, 2021
50580-791 50580-791 Kenvue Brands LLC — June 21, 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 · 11 sections on this page.