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Childrens Cetirizine Hydrochloride

Cetirizine Hydrochloride · Solution

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
childrens cetirizine hydrochloride
Generic name
Cetirizine Hydrochloride
Dosage form
Solution
Route
Oral
Marketing category
ANDA · ANDA
Labeler
Proficient Rx LP
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
2
NDC product codes
10
Packages
21
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 1 mg/mL 1014678 View
Cetirizine Hydrochloride 5 mg/5mL 1014678 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Solution
Route of administration
Oral
Presentations
31

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
090182
Application type
ANDA · Abbreviated New Drug Application
Approval date
April 22, 2008
Sponsor
TARO
Products on application
2
Submissions recorded
5
Products approved under application 090182.
Product Trade name Form Strength Ingredient Status TE Flags
090182-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF SOLUTION CETIRIZINE HYDROCHLORIDE Over-the-counter —
090182-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY SOLUTION CETIRIZINE HYDROCHLORIDE Over-the-counter —

Approval history

Source: Drugs@FDA
Most recent submissions on application 090182.
Type No. Action Status Date Review
Supplement 21 Labeling Approved April 13, 2015 Standard
Supplement 14 Labeling Approved May 28, 2013 —
Supplement 7 Manufacturing (CMC) Approved October 1, 2011 —
Supplement 2 Labeling Approved May 28, 2009 —
Original application 1 Approved April 22, 2008 —

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260901). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20260901 HUMAN OTC DRUG · 20260607 HUMAN OTC DRUG · 20260325 HUMAN OTC DRUG · 20260213

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 Antihistamine

Dosage and Administration

openFDA Drug Labeling

Directions • use only with enclosed dosing cup • find right dose on chart below • mL = milliliter adults and children 6 years and over 5 mL or 10 mL once daily depending upon severity of symptoms; do not take more than 10 mL in 24 hours. adults 65 years and over 5 mL once daily; do not take more than 5 mL in 24 hours. children 2 to under 6 years of age 2.5 mL once daily. If needed, dose can be increased to a maximum of 5 mL once daily or 2.5 mL every 12 hours. Do not give more than 5 mL in 24 hours. children under 2 years of age ask a doctor consumers with liver or kidney disease ask a doctor Other information • store between 20° to 25°C (68° to 77°F) • do not use if carton is opened, or if printed neckband is broken or missing • see bottom panel for lot number and expiration date

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 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 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 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 5 mL teaspoonful) Cetirizine HCl 5 mg

How Supplied / Storage and Handling

openFDA Drug Labeling

Cetirizine HCL Oral Suspension 1 mg/ mL is a grape-flavored suspension. Available in these presentations: 17856-6765-01 - 5 mL (CUP) 72 ct UD 17856-6765-03 - 2.5 mL (Enfit Syringe) 120 ct UD 17856-6765-09 - 2.5 mL (Enfit Syringe) 90 ct UD Store between 20° to 25°C (68° to 77°F). Excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

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
50090-1103-0 50090-1103 A-S Medication Solutions 1 BOTTLE in 1 CARTON (50090-1103-0) / 120 mL in 1 BOTTLE November 28, 2014
17856-6765-1 17856-6765 ATLANTIC BIOLOGICALS CORP. 72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-6765-1) / 5 mL in 1 CUP, UNIT-DOSE December 12, 2024
17856-6765-3 17856-6765 ATLANTIC BIOLOGICALS CORP. 120 SYRINGE in 1 CASE (17856-6765-3) / 2.5 mL in 1 SYRINGE April 30, 2026
17856-6765-9 17856-6765 ATLANTIC BIOLOGICALS CORP. 90 SYRINGE in 1 CASE (17856-6765-9) / 2.5 mL in 1 SYRINGE August 31, 2026
68016-023-43 68016-023 Chain Drug Consortium, LLC (Premier Value) 1 BOTTLE in 1 CARTON (68016-023-43) / 120 mL in 1 BOTTLE April 22, 2008
0904-6765-20 0904-6765 Major Pharmaceuticals 1 BOTTLE in 1 CARTON (0904-6765-20) / 118 mL in 1 BOTTLE August 22, 2018
68788-8188-1 68788-8188 Preferred Pharmaceuticals Inc. 1 BOTTLE in 1 CARTON (68788-8188-1) / 118 mL in 1 BOTTLE May 13, 2022
71205-705-72 71205-705 Proficient Rx LP 1 BOTTLE in 1 CARTON (71205-705-72) / 120 mL in 1 BOTTLE October 13, 2022
71205-722-04 71205-722 Proficient Rx LP 1 BOTTLE in 1 CARTON (71205-722-04) / 118 mL in 1 BOTTLE November 17, 2022
51672-2102-1 51672-2102 Sun Pharmaceutical Industries, Inc. 1 BOTTLE in 1 CARTON (51672-2102-1) / 240 mL in 1 BOTTLE September 8, 2011
51672-2102-2 51672-2102 Sun Pharmaceutical Industries, Inc. 2 BOTTLE in 1 CARTON (51672-2102-2) / 120 mL in 1 BOTTLE September 8, 2011
51672-2102-4 51672-2102 Sun Pharmaceutical Industries, Inc. 1 BOTTLE in 1 CARTON (51672-2102-4) / 60 mL in 1 BOTTLE September 8, 2011
51672-2102-7 51672-2102 Sun Pharmaceutical Industries, Inc. 2 BOTTLE in 1 CARTON (51672-2102-7) / 240 mL in 1 BOTTLE September 8, 2011
51672-2102-8 51672-2102 Sun Pharmaceutical Industries, Inc. 1 BOTTLE in 1 CARTON (51672-2102-8) / 120 mL in 1 BOTTLE September 8, 2011
51672-2147-1 51672-2147 Sun Pharmaceutical Industries, Inc. 1 BOTTLE in 1 CARTON (51672-2147-1) / 240 mL in 1 BOTTLE March 20, 2025
51672-2147-8 51672-2147 Sun Pharmaceutical Industries, Inc. 1 BOTTLE in 1 CARTON (51672-2147-8) / 120 mL in 1 BOTTLE March 20, 2025
83939-0009-1 83939-0009 VERITYRX, LLC 5 mL in 1 CUP, UNIT-DOSE (83939-0009-1) November 3, 2025
83939-0009-2 83939-0009 VERITYRX, LLC 10 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (83939-0009-2) / 5 mL in 1 CUP, UNIT-DOSE November 10, 2025
83939-0009-3 83939-0009 VERITYRX, LLC 40 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (83939-0009-3) / 5 mL in 1 CUP, UNIT-DOSE November 10, 2025
83939-0009-4 83939-0009 VERITYRX, LLC 50 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (83939-0009-4) / 5 mL in 1 CUP, UNIT-DOSE November 10, 2025
83939-0009-5 83939-0009 VERITYRX, LLC 100 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (83939-0009-5) / 5 mL in 1 CUP, UNIT-DOSE November 10, 2025
50090-1103 50090-1103 A-S Medication Solutions — September 8, 2011
17856-6765 17856-6765 ATLANTIC BIOLOGICALS CORP. — August 22, 2018
68016-023 68016-023 Chain Drug Consortium, LLC (Premier Value) — April 22, 2008
0904-6765 0904-6765 Major Pharmaceuticals — August 22, 2018
68788-8188 68788-8188 Preferred Pharmaceuticals Inc. — May 13, 2022
71205-705 71205-705 Proficient Rx LP — September 8, 2011
71205-722 71205-722 Proficient Rx LP — August 22, 2018
51672-2102 51672-2102 Sun Pharmaceutical Industries, Inc. — September 8, 2011
51672-2147 51672-2147 Sun Pharmaceutical Industries, Inc. — March 20, 2025
83939-0009 83939-0009 VERITYRX, LLC — September 8, 2011

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.