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Cetirizine hydrochloride

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
Cetirizine hydrochloride
Generic name
Cetirizine hydrochloride
Dosage form
Tablet, Coated
Route
Oral
Marketing category
ANDA · ANDA
Labeler
A-S Medication Solutions
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
1
NDC product codes
7
Packages
13
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 10 mg/1 1014678 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet, Coated
Route of administration
Oral
Presentations
20

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
209274
Application type
ANDA · Abbreviated New Drug Application
Approval date
December 22, 2017
Sponsor
GRANULES
Products on application
1
Submissions recorded
1
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 20260807). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20260807 HUMAN OTC DRUG · 20260714 HUMAN OTC DRUG · 20251204 HUMAN OTC DRUG · 20250513

Indications and Usage

openFDA Drug Labeling

USE(S) 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 adults and children 6 years and over one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg 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

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 tablet) Cetirizine hydrochloride 10 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
50090-6538-1 50090-6538 A-S Medication Solutions 30 TABLET, COATED in 1 BOTTLE (50090-6538-1) July 4, 2023
50090-6538-3 50090-6538 A-S Medication Solutions 90 TABLET, COATED in 1 BOTTLE (50090-6538-3) July 5, 2023
50090-6679-0 50090-6679 A-S Medication Solutions 30 TABLET, COATED in 1 BOTTLE (50090-6679-0) September 11, 2023
50090-6679-1 50090-6679 A-S Medication Solutions 90 TABLET, COATED in 1 BOTTLE (50090-6679-1) September 13, 2023
80513-731-05 80513-731 Advanced Rx LLC 500 TABLET, COATED in 1 BOTTLE (80513-731-05) May 1, 2025
80513-731-12 80513-731 Advanced Rx LLC 120 TABLET, COATED in 1 BOTTLE (80513-731-12) May 1, 2025
62207-764-49 62207-764 Granules India Ltd 1000 TABLET, COATED in 1 BOTTLE (62207-764-49) May 28, 2018
62207-764-55 62207-764 Granules India Ltd 14 TABLET, COATED in 1 BOTTLE (62207-764-55) May 28, 2018
62207-764-73 62207-764 Granules India Ltd 13 BLISTER PACK in 1 CARTON (62207-764-73) / 10 TABLET, COATED in 1 BLISTER PACK May 28, 2018
70010-163-05 70010-163 Granules Pharmaceuticals Inc. 500 TABLET, COATED in 1 BOTTLE (70010-163-05) January 13, 2022
70010-163-09 70010-163 Granules Pharmaceuticals Inc. 90 TABLET, COATED in 1 BOTTLE (70010-163-09) April 26, 2022
71141-194-14 71141-194 LIDL US LLC 1 BOTTLE, PLASTIC in 1 CARTON (71141-194-14) / 30 TABLET, COATED in 1 BOTTLE, PLASTIC March 30, 2021
0615-8479-39 0615-8479 NCS HealthCare of KY, LLC dba Vangard Labs 30 TABLET, COATED in 1 BLISTER PACK (0615-8479-39) July 31, 2023
50090-6538 50090-6538 A-S Medication Solutions — January 13, 2022
50090-6679 50090-6679 A-S Medication Solutions — January 13, 2022
80513-731 80513-731 Advanced Rx LLC — May 1, 2025
62207-764 62207-764 Granules India Ltd — May 28, 2018
70010-163 70010-163 Granules Pharmaceuticals Inc. — January 13, 2022
71141-194 71141-194 LIDL US LLC — March 30, 2021
0615-8479 0615-8479 NCS HealthCare of KY, LLC dba Vangard Labs — January 13, 2022

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.