Indications and uses
• 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
• 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
adults & children 6 years & over one 10 mg caplet once daily; do not take more than one 10 mg caplet in 24 hours. A 5 mg product may be appropriate for less severe symptoms adults 65 years & over ask a doctor children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor
Cetirizine HCl 10mg
Antihistamine
• 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
if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.
liver or kidny disease. Your doctor should determine if you need a different dose.
taking tranquilizers or sedatives.
• drowsiness may occur • avoid alcoholic drinks • alcohol, sedatives, and tranquilizers may increase drowsiness
• be careful when driving a motor vehicle or operating machinery
an allergic reaction to this product occurs. Seek medical help right away.
• if breast-feeding: not recommended
• if pregnant: ask a health professional before use.
In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
| adults & children 6 years & over | one 10 mg caplet once daily; do not take more than one 10 mg caplet in 24 hours. A 5 mg product may
be appropriate for less severe symptoms |
| adults 65 years & over | ask a doctor |
| children under 6 years of age | ask a doctor |
| consumers with liver or kidney disease | ask a doctor |
• store between 20°–25°C (68° –77°F)
hypromellose, lactose, magnesium stearate, maize starch, polyethylene glycol, povidone, titanium dioxide
908-242-6108
| Class | Version | Type | Effective |
|---|---|---|---|
| CETIRIZINE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| c505bb17-4ff9-45f9-ac2d-bb9c8c9d35be | Product name | 1 | 20200304 |
| a255659f-db40-429d-8c07-5f173f330d9c | Product name | 1 | 20190402 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 82725-3003-2 | Cabinet Allergy Relief Refill Cetirizine HCI | 40 in 1 POUCH | TABLET | 40 | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 82725-3003 | 82725-3003-2 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| HYPROMELLOSE, UNSPECIFIED | 3NXW29V3WO | IACT |
| LACTOSE, UNSPECIFIED FORM | J2B2A4N98G | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| POVIDONE, UNSPECIFIED | FZ989GH94E | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| CETIRIZINE HYDROCHLORIDE | 64O047KTOA | ACTIM |
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A077829-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET / ORAL | 2009-08-26 | ||
| A077829-002 | CETIRIZINE HYDROCHLORIDE HIVES | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | RS | 2009-08-26 | |
| A077829-003 | CETIRIZINE HYDROCHLORIDE HIVES | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET / ORAL | 2009-08-26 | ||
| A077829-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2009-08-26 |
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A077829-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2009-08-26 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A077829-002 | CETIRIZINE HYDROCHLORIDE HIVES | 10MG | TABLET / ORAL | RS | 2009-08-26 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A077829-003 | CETIRIZINE HYDROCHLORIDE HIVES | 5MG | TABLET / ORAL | 2009-08-26 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A077829-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2009-08-26 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A077829-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2009-08-26 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A077829-002 | CETIRIZINE HYDROCHLORIDE HIVES | 10MG | TABLET / ORAL | RS | 2009-08-26 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A077829-003 | CETIRIZINE HYDROCHLORIDE HIVES | 5MG | TABLET / ORAL | 2009-08-26 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A077829-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2009-08-26 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A077829-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2009-08-26 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A077829-002 | CETIRIZINE HYDROCHLORIDE HIVES | 10MG | TABLET / ORAL | RS | 2009-08-26 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077829-003 | CETIRIZINE HYDROCHLORIDE HIVES | 5MG | TABLET / ORAL | 2009-08-26 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A077829-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2009-08-26 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077829-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2009-08-26 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077829-002 | CETIRIZINE HYDROCHLORIDE HIVES | 10MG | TABLET / ORAL | RS | 2009-08-26 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077829-003 | CETIRIZINE HYDROCHLORIDE HIVES | 5MG | TABLET / ORAL | 2009-08-26 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077829-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2009-08-26 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077829-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2009-08-26 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077829-002 | CETIRIZINE HYDROCHLORIDE HIVES | 10MG | TABLET / ORAL | RS | 2009-08-26 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077829-003 | CETIRIZINE HYDROCHLORIDE HIVES | 5MG | TABLET / ORAL | 2009-08-26 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077829-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2009-08-26 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077829-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2009-08-26 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077829-002 | CETIRIZINE HYDROCHLORIDE HIVES | 10MG | TABLET / ORAL | RS | 2009-08-26 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077829-003 | CETIRIZINE HYDROCHLORIDE HIVES | 5MG | TABLET / ORAL | 2009-08-26 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077829-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2009-08-26 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077829-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2009-08-26 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077829-002 | CETIRIZINE HYDROCHLORIDE HIVES | 10MG | TABLET / ORAL | RS | 2009-08-26 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077829-003 | CETIRIZINE HYDROCHLORIDE HIVES | 5MG | TABLET / ORAL | 2009-08-26 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077829-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2009-08-26 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077829-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2009-08-26 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077829-002 | CETIRIZINE HYDROCHLORIDE HIVES | 10MG | TABLET / ORAL | RS | 2009-08-26 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077829-003 | CETIRIZINE HYDROCHLORIDE HIVES | 5MG | TABLET / ORAL | 2009-08-26 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077829-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2009-08-26 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077829-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2009-08-26 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077829-002 | CETIRIZINE HYDROCHLORIDE HIVES | 10MG | TABLET / ORAL | RS | 2009-08-26 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077829-003 | CETIRIZINE HYDROCHLORIDE HIVES | 5MG | TABLET / ORAL | 2009-08-26 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077829-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2009-08-26 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077829-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2009-08-26 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077829-002 | CETIRIZINE HYDROCHLORIDE HIVES | 10MG | TABLET / ORAL | RS | 2009-08-26 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077829-003 | CETIRIZINE HYDROCHLORIDE HIVES | 5MG | TABLET / ORAL | 2009-08-26 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077829-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2009-08-26 | 5bbf6a4d5a75… |
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Cabinet Allergy Relief Refill Cetirizine HCI | CETIRIZINE HYDROCHLORIDE | Cabinet Health P.B.C. | 0eaf9d27-e221-4cdd-97bc-478c775e3d67 | 2025-07-03 | Warnings | 82725-3003-2 82725-3003 82725300302 390da0b9-8970-1b38-e063-6394a90ac470 0eaf9d27-e221-4cdd-97bc-478c775e3d67 |
Adverse event summaries are temporarily unavailable. Other product information remains available.