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CAREALL Allergy Relief

Cetirizine HCl · Tablet

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

CAREALL Allergy Relief

Generic name

Cetirizine HCl

Dosage form

Tablet

Route

Oral

Marketing category

ANDA · ANDA

Labeler

New World Imports

Product type

Human Otc Drug

DEA schedule

Not scheduled

Active ingredients

NDC product codes

Packages

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
Loratadine	10 mg/1	311372	View

Forms, strengths and routes

Source: NDC Directory

Dosage form

Tablet

Route of administration

Oral

Presentations

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

209274

Application type

ANDA · Abbreviated New Drug Application

Approval date

December 22, 2017

Sponsor

GRANULES

Products on application

Submissions recorded

Products approved under application 209274.
Product	Trade name	Form	Strength	Ingredient	Status	TE	Flags
209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	TABLET		CETIRIZINE HYDROCHLORIDE	Over-the-counter	—

Approval history

Source: Drugs@FDA

Most recent submissions on application 209274.
Type	No.	Action	Status	Date	Review
Original application	1		Approved	December 22, 2017	Standard

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20251201). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20251201 HUMAN OTC DRUG · 20251201

Indications and Usage

openFDA Drug Labeling

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

Purpose

openFDA Drug Labeling

Antihistamine

Dosage and Administration

openFDA Drug Labeling

Adult and children over 6 years old: One 10mg tablet once daily: no more than one 10mg tablet in 24 hours. A 5mg product may be appropriate for less severe symptoms Adults 65 years and over: ask a doctor Children under 6 years of age: ask a doctor Consumers with liver or kidney disease : ask a doctor

Warnings

openFDA Drug Labeling

Do not use if you have ever had an allergic reaction to this product or any of its ingredients or 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 sedatives or tranquilizers 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.

Active Ingredient

openFDA Drug Labeling

Cetirizine HCl 10mg

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
51824-103-30	51824-103	New World Imports	30 TABLET in 1 BOTTLE (51824-103-30)	December 7, 2023
51824-104-30	51824-104	New World Imports	30 TABLET in 1 BOTTLE (51824-104-30)	December 7, 2023
51824-103	51824-103	New World Imports	—	December 7, 2023
51824-104	51824-104	New World Imports	—	December 7, 2023

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.