Childrens — Solution

Overview

Brand name

Childrens Allergy Relief

Generic name

Cetirizine Hydrochloride

Dosage form

Solution

Route

Oral

Marketing category

ANDA · ANDA

Labeler

Wal-Mart Stores Inc

Product type

Human Otc Drug

DEA schedule

Not scheduled

Active ingredients

1

NDC product codes

2

Packages

2

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/5mL	1014678	View

Forms, strengths and routes

Source: NDC Directory

Dosage form

Solution

Route of administration

Oral

Presentations

4

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@FDA NDC Directory

Application number

201546

Application type

ANDA · Abbreviated New Drug Application

Approval date

May 20, 2011

Sponsor

TARO

Products on application

2

Submissions recorded

3

Products approved under application 201546.
Product	Trade name	Form	Strength	Ingredient	Status	TE	Flags
201546-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	SOLUTION		CETIRIZINE HYDROCHLORIDE	Over-the-counter	—
201546-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	SOLUTION		CETIRIZINE HYDROCHLORIDE	Over-the-counter	—

Approval history

Source: Drugs@FDA

Most recent submissions on application 201546.
Type	No.	Action	Status	Date	Review
Supplement	2	Manufacturing (CMC)	Approved	April 6, 2015	—
Supplement	1	Labeling	Approved	July 7, 2011	—
Original application	1	Not Applicable	Approved	May 20, 2011	—

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20180214). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20180214 HUMAN OTC DRUG · 20170612

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 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

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. 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

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 5 mL) Cetirizine HCl 5 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
68016-106-08	68016-106	Pharmacy Value Alliance LLC	1 BOTTLE in 1 CARTON (68016-106-08) / 118 mL in 1 BOTTLE	May 20, 2011
49035-106-08	49035-106	Wal-Mart Stores Inc	1 BOTTLE in 1 CARTON (49035-106-08) / 120 mL in 1 BOTTLE	May 20, 2011
68016-106	68016-106	Pharmacy Value Alliance LLC	—	May 20, 2011
49035-106	49035-106	Wal-Mart Stores Inc	—	May 20, 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 · 10 sections on this page.