careone childrens allergy relief — Solution

Overview

Brand name

careone childrens allergy relief

Generic name

Cetirizine HCl

Dosage form

Solution

Route

Oral

Marketing category

ANDA · ANDA

Labeler

American Sales Company

Product type

Human Otc Drug

DEA schedule

Not scheduled

Active ingredients

2

NDC product codes

3

Packages

3

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
Diphenhydramine Hydrochloride	12.5 mg/5mL	1049630	View

Forms, strengths and routes

Source: NDC Directory

Dosage form

Solution

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
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

204226

Application type

ANDA · Abbreviated New Drug Application

Approval date

September 9, 2013

Sponsor

PERRIGO R AND D

Products on application

1

Submissions recorded

2

Products approved under application 204226.
Product	Trade name	Form	Strength	Ingredient	Status	TE	Flags
204226-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	SOLUTION		CETIRIZINE HYDROCHLORIDE	Over-the-counter	—

Approval history

Source: Drugs@FDA

Most recent submissions on application 204226.
Type	No.	Action	Status	Date	Review
Supplement	5	Labeling	Approved	April 15, 2015	Standard
Original application	1		Approved	September 9, 2013	—

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260407). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20260407 HUMAN OTC DRUG · 20250612 HUMAN OTC DRUG · 20240719

Indications and Usage

openFDA Drug Labeling

Uses • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: • sneezing • itching of the nose or throat • runny nose • itchy, watery eyes

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 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

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.

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 the child has • a breathing problem such as chronic bronchitis • glaucoma • a sodium-restricted diet

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) Diphenhydramine HCl 12.5 mg

Adverse event reports

Source: openFDA FAERS

172,003

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: DIPHENHYDRAMINE 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
41520-301-26	41520-301	American Sales Company	1 BOTTLE in 1 CARTON (41520-301-26) / 118 mL in 1 BOTTLE	October 9, 2017
41520-632-26	41520-632	American Sales Company	1 BOTTLE in 1 CARTON (41520-632-26) / 118 mL in 1 BOTTLE	April 12, 2016
41520-902-26	41520-902	American Sales Company	1 BOTTLE in 1 CARTON (41520-902-26) / 118 mL in 1 BOTTLE	June 23, 2016
41520-301	41520-301	American Sales Company	—	October 9, 2017
41520-632	41520-632	American Sales Company	—	April 12, 2016
41520-902	41520-902	American Sales Company	—	June 23, 2016

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.