Indications and 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
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
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
■ store between 20° to 25°C (68° to 77°F) ■ contains no ingredient made from a gluten-containing grain (Wheat, barley or rye)
Cetirizine HCl 10 mg
Antihistamine
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
if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.
liver or kidney 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 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
■ store between 20° to 25°C (68° to 77°F)
■ contains no ingredient made from a gluten-containing grain (Wheat, barley or rye)
colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide.
call 1-877-770-3183: Weekdays 9:00 AM to 4:30 PM EST.
| 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 |
|---|---|---|---|---|---|---|
| 72476-764-03 | Cetirizine Hydrochloride | 30 in 1 BOTTLE | TABLET | 30 | 7 | |
| 72476-764-09 | Cetirizine Hydrochloride | 90 in 1 BOTTLE | TABLET | 90 | 7 | |
| 72476-764-16 | Cetirizine Hydrochloride | 14 in 1 BLISTER PACK | TABLET | 14 | 7 | |
| 72476-764-23 | Cetirizine Hydrochloride | 120 in 1 BOTTLE | TABLET | 120 | 7 | |
| 72476-764-70 | Cetirizine Hydrochloride | 70 in 1 BOTTLE | TABLET | 70 | 7 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 72476-764 | 72476-764-16, 72476-764-09, 72476-764-23, 72476-764-03, 72476-764-70 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CETIRIZINE HYDROCHLORIDE | 64O047KTOA | ACTIB |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| CROSCARMELLOSE SODIUM | M28OL1HH48 | IACT |
| HYPROMELLOSES | 3NXW29V3WO | IACT |
| LACTOSE MONOHYDRATE | EWQ57Q8I5X | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
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 |
|---|---|---|---|---|---|---|---|
| A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2017-12-22 |
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 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | f41ea6bd6efb… |
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 |
|---|---|---|---|---|---|---|
| Cetirizine Hydrochloride | CETIRIZINE HYDROCHLORIDE | RETAIL BUSINESS SERVICES,LLC. | 9f04520e-161d-3f7b-e053-2a95a90a678d | 2025-12-19 | Warnings | 72476-764-70 72476-764-09 72476-764-23 72476-764-03 72476-764-16 72476-764 72476076403 72476076423 72476076416 72476076409 72476076470 46518a5f-819b-3a94-e063-6294a90a4533 9f04520e-161d-3f7b-e053-2a95a90a678d |
Adverse event summaries are temporarily unavailable. Other product information remains available.