On this page
Cetirizine Hydrochloride
Overview
Active ingredients
Source: NDC DirectoryForms, strengths and routes
Source: NDC DirectoryPharmacologic classes are listed in the class section below.
Pharmacologic class
Source: NDC Directory| 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| Product | Trade name | Form | Strength | Ingredient | Status | TE | Flags |
|---|---|---|---|---|---|---|---|
| 078692-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | TABLET, CHEWABLE | CETIRIZINE HYDROCHLORIDE | Over-the-counter | — | ||
| 078692-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | TABLET, CHEWABLE | CETIRIZINE HYDROCHLORIDE | Over-the-counter | — | RS |
Therapeutic equivalence
Source: Orange BookCodes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Supplement | 16 | Labeling | Approved | August 1, 2025 | Standard |
| Original application | 1 | Approved | February 14, 2008 | — |
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260603). This is the manufacturer's labelling text, not a summary and not advice.
Indications and Usage
openFDA Drug LabelingUses 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 LabelingPurpose Antihistamine
Dosage and Administration
openFDA Drug LabelingDirections • may be taken with or without water • chew or crush tablets completely before swallowing adults and children 6 years and over Chew and swallow 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 Other information • Store between 20oC to 25o C (68oF to 77o F)
Warnings
openFDA Drug LabelingWarnings 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 (1-800-222-1222). 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.
Do Not Use
openFDA Drug LabelingDo 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 LabelingAsk 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 LabelingStop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.
Active Ingredient
openFDA Drug LabelingActive ingredient (in each chewable tablet) Cetirizine hydrochloride, USP 10 mg
Adverse event reports
Source: openFDA FAERSAttributed 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.
Recalls
Source: FDA Enforcement| Classification | Reported | Firm | Reason | Status |
|---|---|---|---|---|
| Class III | October 24, 2012 | Sandoz Incorporated | Impurity/Degradation; exceeded impurity specification at the 8 and 15 month time points (betacyclodextrin ester 1&2) | Terminated |
Packaging and NDCs
Source: NDC Directory| Package NDC | Product NDC | Labeler | Description | Marketing start |
|---|---|---|---|---|
| 65498-753-00 | 65498-753 | Kenvue Canada Inc. | 74050 TABLET, CHEWABLE in 1 DRUM (65498-753-00) | February 1, 2022 |
| 65498-790-00 | 65498-790 | Kenvue Canada Inc. | 296350 TABLET, CHEWABLE in 1 DRUM (65498-790-00) | February 1, 2022 |
| 65498-791-00 | 65498-791 | Kenvue Canada Inc. | 74050 TABLET, CHEWABLE in 1 DRUM (65498-791-00) | February 1, 2022 |
| 65498-792-00 | 65498-792 | Kenvue Canada Inc. | 148150 TABLET, CHEWABLE in 1 DRUM (65498-792-00) | February 1, 2022 |
| 51660-066-30 | 51660-066 | OHM LABORATORIES INC. | 1 BOTTLE in 1 CARTON (51660-066-30) / 30 TABLET, CHEWABLE in 1 BOTTLE | July 21, 2022 |
| 0781-5283-64 | 0781-5283 | Sandoz Inc | 30 BLISTER PACK in 1 CARTON (0781-5283-64) / 1 TABLET, CHEWABLE in 1 BLISTER PACK (0781-5283-06) | February 14, 2008 |
| 0781-5284-64 | 0781-5284 | Sandoz Inc | 30 BLISTER PACK in 1 CARTON (0781-5284-64) / 1 TABLET, CHEWABLE in 1 BLISTER PACK (0781-5284-06) | February 14, 2008 |
| 65498-753 | 65498-753 | Kenvue Canada Inc. | — | February 1, 2022 |
| 65498-790 | 65498-790 | Kenvue Canada Inc. | — | February 1, 2022 |
| 65498-791 | 65498-791 | Kenvue Canada Inc. | — | February 1, 2022 |
| 65498-792 | 65498-792 | Kenvue Canada Inc. | — | February 1, 2022 |
| 51660-066 | 51660-066 | OHM LABORATORIES INC. | — | July 21, 2022 |
| 0781-5283 | 0781-5283 | Sandoz Inc | — | February 14, 2008 |
| 0781-5284 | 0781-5284 | Sandoz Inc | — | February 14, 2008 |
Sources for 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 |
| Enforcement | FDA | Recall records |
Generated September 25, 2026 · 13 sections on this page.