Cetirizine Hydrochloride Tablets,10 mg

Overview

Brand name

Cetirizine Hydrochloride Tablets,10 mg

Generic name

Cetirizine Hydrochloride

Dosage form

Tablet

Route

Oral

Marketing category

ANDA · ANDA

Labeler

TIME CAP LABORATORIES, INC.

Product type

Human Otc Drug

DEA schedule

Not scheduled

Active ingredients

1

NDC product codes

2

Packages

8

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

Forms, strengths and routes

Source: NDC Directory

Dosage form

Tablet

Route of administration

Oral

Presentations

10

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

078933

Application type

ANDA · Abbreviated New Drug Application

Approval date

June 15, 2010

Sponsor

MARKSANS PHARMA

Products on application

4

Submissions recorded

2

Products approved under application 078933.
Product	Trade name	Form	Ingredient	Status	TE
078933-001	CETIRIZINE HYDROCHLORIDE ALLERGY	TABLET	CETIRIZINE HYDROCHLORIDE	Over-the-counter	—
078933-002	CETIRIZINE HYDROCHLORIDE ALLERGY	TABLET	CETIRIZINE HYDROCHLORIDE	Over-the-counter	—
078933-003	CETIRIZINE HYDROCHLORIDE HIVES	TABLET	CETIRIZINE HYDROCHLORIDE	Over-the-counter	—
078933-004	CETIRIZINE HYDROCHLORIDE HIVES	TABLET	CETIRIZINE HYDROCHLORIDE	Over-the-counter	—

Approval history

Source: Drugs@FDA

Most recent submissions on application 078933.
Type	No.	Action	Status	Date	Review
Supplement	5	Manufacturing (CMC)	Approved	April 13, 2023	Unknown
Original application	1		Approved	June 15, 2010	—

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20240306). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20240306

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 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 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 HCl 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
51655-842-26	51655-842	Northwind Health Company, LLC	90 TABLET in 1 BOTTLE, PLASTIC (51655-842-26)	February 7, 2023
51655-842-52	51655-842	Northwind Health Company, LLC	30 TABLET in 1 BOTTLE, PLASTIC (51655-842-52)	April 7, 2023
51655-842-60	51655-842	Northwind Health Company, LLC	100 TABLET in 1 BOTTLE, PLASTIC (51655-842-60)	March 30, 2023
51655-842-84	51655-842	Northwind Health Company, LLC	14 TABLET in 1 BOTTLE, PLASTIC (51655-842-84)	March 10, 2023
49483-692-01	49483-692	TIME CAP LABORATORIES, INC.	100 TABLET in 1 BOTTLE (49483-692-01)	March 11, 2024
49483-692-20	49483-692	TIME CAP LABORATORIES, INC.	200 TABLET in 1 BOTTLE (49483-692-20)	March 11, 2024
49483-692-50	49483-692	TIME CAP LABORATORIES, INC.	500 TABLET in 1 BOTTLE (49483-692-50)	May 30, 2022
49483-692-65	49483-692	TIME CAP LABORATORIES, INC.	365 TABLET in 1 BOTTLE (49483-692-65)	February 12, 2022
51655-842	51655-842	Northwind Health Company, LLC	—	February 7, 2023
49483-692	49483-692	TIME CAP LABORATORIES, INC.	—	February 12, 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 · 10 sections on this page.