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Cetirizine HCl
Cetirizine · Tablet
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 |
|---|---|---|---|---|---|---|---|
| 078427-003 | CETIRIZINE HYDROCHLORIDE ALLERGY | TABLET | CETIRIZINE HYDROCHLORIDE | Over-the-counter | — | ||
| 078427-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | TABLET | CETIRIZINE HYDROCHLORIDE | Over-the-counter | — |
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Supplement | 6 | Manufacturing (CMC) | Approved | April 3, 2025 | Unknown |
| Original application | 1 | Approved | December 28, 2007 | — |
Prescribing information
Source: openFDA Drug LabelingReproduced 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.
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 Cetirizine Hydrochloride Tablets, USP 5 mg adults and children 6 years and over 1 tablet (5 mg) or 2 tablets (10) once daily depending upon severity of symptoms; do not take more than 2 tablets (10) in 24 hours. adults 65 years and over 1 tablet (5 mg) once a day; do not take more than 1 tablet (5 mg) in 24 hours. children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor Cetirizine Hydrochloride Tablets, USP 10 mg 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 LabelingWarnings 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 useif 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)
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 tablet) Cetirizine HCl 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 II | April 16, 2025 | Glenmark Pharmaceuticals Inc., USA | CGMP Deviations | Ongoing |
Packaging and NDCs
Source: NDC Directory| Package NDC | Product NDC | Labeler | Description | Marketing start |
|---|---|---|---|---|
| 72657-128-03 | 72657-128 | GLENMARK THERAPEUTICS INC., USA | 1 BOTTLE in 1 CARTON (72657-128-03) / 300 TABLET in 1 BOTTLE | May 13, 2024 |
| 72657-128-04 | 72657-128 | GLENMARK THERAPEUTICS INC., USA | 1 BOTTLE in 1 CARTON (72657-128-04) / 400 TABLET in 1 BOTTLE | May 13, 2024 |
| 72657-128-08 | 72657-128 | GLENMARK THERAPEUTICS INC., USA | 1 BOTTLE in 1 CARTON (72657-128-08) / 120 TABLET in 1 BOTTLE | May 13, 2024 |
| 72657-128-14 | 72657-128 | GLENMARK THERAPEUTICS INC., USA | 1 BOTTLE in 1 CARTON (72657-128-14) / 140 TABLET in 1 BOTTLE | May 13, 2024 |
| 72657-128-15 | 72657-128 | GLENMARK THERAPEUTICS INC., USA | 1 BOTTLE in 1 CARTON (72657-128-15) / 150 TABLET in 1 BOTTLE | May 13, 2024 |
| 72657-128-18 | 72657-128 | GLENMARK THERAPEUTICS INC., USA | 1 BOTTLE in 1 CARTON (72657-128-18) / 180 TABLET in 1 BOTTLE | May 13, 2024 |
| 72657-128-24 | 72657-128 | GLENMARK THERAPEUTICS INC., USA | 1 BOTTLE in 1 CARTON (72657-128-24) / 240 TABLET in 1 BOTTLE | May 13, 2024 |
| 72657-128-30 | 72657-128 | GLENMARK THERAPEUTICS INC., USA | 1 BOTTLE in 1 CARTON (72657-128-30) / 30 TABLET in 1 BOTTLE | May 13, 2024 |
| 72657-128-35 | 72657-128 | GLENMARK THERAPEUTICS INC., USA | 1 BOTTLE in 1 CARTON (72657-128-35) / 365 TABLET in 1 BOTTLE | May 13, 2024 |
| 72657-128-41 | 72657-128 | GLENMARK THERAPEUTICS INC., USA | 1 BOTTLE in 1 CARTON (72657-128-41) / 14 TABLET in 1 BOTTLE | May 13, 2024 |
| 72657-128-45 | 72657-128 | GLENMARK THERAPEUTICS INC., USA | 1 BOTTLE in 1 CARTON (72657-128-45) / 45 TABLET in 1 BOTTLE | May 13, 2024 |
| 72657-128-60 | 72657-128 | GLENMARK THERAPEUTICS INC., USA | 1 BOTTLE in 1 CARTON (72657-128-60) / 60 TABLET in 1 BOTTLE | May 13, 2024 |
| 72657-128-70 | 72657-128 | GLENMARK THERAPEUTICS INC., USA | 1 BOTTLE in 1 CARTON (72657-128-70) / 70 TABLET in 1 BOTTLE | May 13, 2024 |
| 72657-128-81 | 72657-128 | GLENMARK THERAPEUTICS INC., USA | 2 BOTTLE in 1 CARTON (72657-128-81) / 60 TABLET in 1 BOTTLE | May 13, 2024 |
| 72657-128-82 | 72657-128 | GLENMARK THERAPEUTICS INC., USA | 2 BOTTLE in 1 CARTON (72657-128-82) / 70 TABLET in 1 BOTTLE | May 13, 2024 |
| 72657-128-84 | 72657-128 | GLENMARK THERAPEUTICS INC., USA | 2 BOTTLE in 1 CARTON (72657-128-84) / 90 TABLET in 1 BOTTLE | May 13, 2024 |
| 72657-128-86 | 72657-128 | GLENMARK THERAPEUTICS INC., USA | 2 BOTTLE in 1 CARTON (72657-128-86) / 120 TABLET in 1 BOTTLE | May 13, 2024 |
| 72657-128-90 | 72657-128 | GLENMARK THERAPEUTICS INC., USA | 1 BOTTLE in 1 CARTON (72657-128-90) / 90 TABLET in 1 BOTTLE | May 13, 2024 |
| 72657-129-03 | 72657-129 | GLENMARK THERAPEUTICS INC., USA | 1 BOTTLE in 1 CARTON (72657-129-03) / 300 TABLET in 1 BOTTLE | May 13, 2024 |
| 72657-129-04 | 72657-129 | GLENMARK THERAPEUTICS INC., USA | 1 BOTTLE in 1 CARTON (72657-129-04) / 400 TABLET in 1 BOTTLE | May 13, 2024 |
| 72657-129-08 | 72657-129 | GLENMARK THERAPEUTICS INC., USA | 1 BOTTLE in 1 CARTON (72657-129-08) / 120 TABLET in 1 BOTTLE | May 13, 2024 |
| 72657-129-14 | 72657-129 | GLENMARK THERAPEUTICS INC., USA | 1 BOTTLE in 1 CARTON (72657-129-14) / 140 TABLET in 1 BOTTLE | May 13, 2024 |
| 72657-129-15 | 72657-129 | GLENMARK THERAPEUTICS INC., USA | 1 BOTTLE in 1 CARTON (72657-129-15) / 150 TABLET in 1 BOTTLE | May 13, 2024 |
| 72657-129-18 | 72657-129 | GLENMARK THERAPEUTICS INC., USA | 1 BOTTLE in 1 CARTON (72657-129-18) / 180 TABLET in 1 BOTTLE | May 13, 2024 |
| 72657-129-24 | 72657-129 | GLENMARK THERAPEUTICS INC., USA | 1 BOTTLE in 1 CARTON (72657-129-24) / 240 TABLET in 1 BOTTLE | May 13, 2024 |
| 72657-129-30 | 72657-129 | GLENMARK THERAPEUTICS INC., USA | 1 BOTTLE in 1 CARTON (72657-129-30) / 30 TABLET in 1 BOTTLE | May 13, 2024 |
| 72657-129-35 | 72657-129 | GLENMARK THERAPEUTICS INC., USA | 1 BOTTLE in 1 CARTON (72657-129-35) / 365 TABLET in 1 BOTTLE | May 13, 2024 |
| 72657-129-41 | 72657-129 | GLENMARK THERAPEUTICS INC., USA | 1 BOTTLE in 1 CARTON (72657-129-41) / 14 TABLET in 1 BOTTLE | April 3, 2025 |
| 72657-129-45 | 72657-129 | GLENMARK THERAPEUTICS INC., USA | 1 BOTTLE in 1 CARTON (72657-129-45) / 45 TABLET in 1 BOTTLE | May 13, 2024 |
| 72657-129-60 | 72657-129 | GLENMARK THERAPEUTICS INC., USA | 1 BOTTLE in 1 CARTON (72657-129-60) / 60 TABLET in 1 BOTTLE | May 13, 2024 |
| 72657-129-70 | 72657-129 | GLENMARK THERAPEUTICS INC., USA | 1 BOTTLE in 1 CARTON (72657-129-70) / 70 TABLET in 1 BOTTLE | May 13, 2024 |
| 72657-129-81 | 72657-129 | GLENMARK THERAPEUTICS INC., USA | 2 BOTTLE in 1 CARTON (72657-129-81) / 60 TABLET in 1 BOTTLE | May 13, 2024 |
| 72657-129-82 | 72657-129 | GLENMARK THERAPEUTICS INC., USA | 2 BOTTLE in 1 CARTON (72657-129-82) / 70 TABLET in 1 BOTTLE | May 13, 2024 |
| 72657-129-84 | 72657-129 | GLENMARK THERAPEUTICS INC., USA | 2 BOTTLE in 1 CARTON (72657-129-84) / 90 TABLET in 1 BOTTLE | May 13, 2024 |
| 72657-129-86 | 72657-129 | GLENMARK THERAPEUTICS INC., USA | 2 BOTTLE in 1 CARTON (72657-129-86) / 120 TABLET in 1 BOTTLE | May 13, 2024 |
| 72657-129-90 | 72657-129 | GLENMARK THERAPEUTICS INC., USA | 1 BOTTLE in 1 CARTON (72657-129-90) / 90 TABLET in 1 BOTTLE | May 13, 2024 |
| 79481-7640-6 | 79481-7640 | Meijer | 60 TABLET in 1 BOTTLE (79481-7640-6) | September 9, 2024 |
| 70677-1279-1 | 70677-1279 | Strategic Sourcing Services LLC | 1 BOTTLE in 1 CARTON (70677-1279-1) / 14 TABLET in 1 BOTTLE | April 3, 2025 |
| 70677-1279-2 | 70677-1279 | Strategic Sourcing Services LLC | 1 BOTTLE in 1 CARTON (70677-1279-2) / 30 TABLET in 1 BOTTLE | March 1, 2025 |
| 70677-1279-3 | 70677-1279 | Strategic Sourcing Services LLC | 1 BOTTLE in 1 CARTON (70677-1279-3) / 60 TABLET in 1 BOTTLE | March 1, 2025 |
| 70677-1279-4 | 70677-1279 | Strategic Sourcing Services LLC | 1 BOTTLE in 1 CARTON (70677-1279-4) / 90 TABLET in 1 BOTTLE | March 1, 2025 |
| 70677-1279-5 | 70677-1279 | Strategic Sourcing Services LLC | 1 BOTTLE in 1 CARTON (70677-1279-5) / 300 TABLET in 1 BOTTLE | March 1, 2025 |
| 72657-128 | 72657-128 | GLENMARK THERAPEUTICS INC., USA | — | May 13, 2024 |
| 72657-129 | 72657-129 | GLENMARK THERAPEUTICS INC., USA | — | May 13, 2024 |
| 79481-7640 | 79481-7640 | Meijer | — | September 9, 2024 |
| 70677-1279 | 70677-1279 | Strategic Sourcing Services LLC | — | March 1, 2025 |
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 · 12 sections on this page.