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) TAMPER EVIDENT: DO NOT USE IF SEAL OVER BOTTLE OPENING IS BROKEN OR MISSING.
Drug Facts
Cetirizine hydrochloride USP 10 mg
Antihistamine
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
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.
liver or kidney disease. Your doctor should determine if you need a different dose.
taking tranquilizers or sedatives.
an allergic reaction to this product occurs. Seek medical help right away.
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 |
colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide.
call 1-855-274-4122
Distributed by:
AUROHEALTH LLC
279 Princeton-Hightstown Road,
East Windsor, NJ 08520
Made in India
Healthy Living™
ALLERGY RELIEF
CETIRIZINE HYDROCHLORIDE
Tablets USP 10 mg
Antihistamine
Original Prescription Strength
Indoor & Outdoor Allergies
10 mg Strength Tablets
*Compare
to the Active
Ingredient in
Zyrtec®
24 Hour Relief of:
• Sneezing • Runny Nose
• Itchy, Watery Eyes
• Itchy Throat or Nose
500
Tablets
10 mg each
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0358602861407 | GTIN-13: 0358602861407 EAN-13: 0358602861407 GTIN-12: 358602861407 UPC-A: 358602861407 GTIN storage (14 digits): 00358602861407 | cetirizine-fig1.jpg |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 58602-861 | 58602-861-21, 58602-861-29, 58602-861-40 |
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 |
| HYPROMELLOSE 2910 (5 MPA.S) | R75537T0T4 | IACT |
| LACTOSE MONOHYDRATE | EWQ57Q8I5X | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| POLYETHYLENE GLYCOL 400 | B697894SGQ | 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 |
|---|---|---|---|---|---|---|---|
| A090760-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET / ORAL | 2015-08-05 | ||
| A090760-002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET / ORAL | 2015-08-05 | ||
| A090760-003 | CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2015-08-05 | ||
| A090760-004 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2015-08-05 |
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 | A090760-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2015-08-05 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A090760-002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG | TABLET / ORAL | 2015-08-05 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A090760-003 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2015-08-05 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A090760-004 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | TABLET / ORAL | 2015-08-05 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A090760-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2015-08-05 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A090760-002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG | TABLET / ORAL | 2015-08-05 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A090760-003 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2015-08-05 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A090760-004 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | TABLET / ORAL | 2015-08-05 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A090760-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2015-08-05 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A090760-002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG | TABLET / ORAL | 2015-08-05 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A090760-003 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2015-08-05 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A090760-004 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | TABLET / ORAL | 2015-08-05 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090760-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2015-08-05 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090760-002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG | TABLET / ORAL | 2015-08-05 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090760-003 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2015-08-05 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090760-004 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | TABLET / ORAL | 2015-08-05 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A090760-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2015-08-05 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A090760-002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG | TABLET / ORAL | 2015-08-05 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A090760-003 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2015-08-05 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A090760-004 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | TABLET / ORAL | 2015-08-05 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090760-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2015-08-05 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090760-002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG | TABLET / ORAL | 2015-08-05 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090760-003 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2015-08-05 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090760-004 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | TABLET / ORAL | 2015-08-05 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090760-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2015-08-05 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090760-002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG | TABLET / ORAL | 2015-08-05 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090760-003 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2015-08-05 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090760-004 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | TABLET / ORAL | 2015-08-05 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090760-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2015-08-05 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090760-002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG | TABLET / ORAL | 2015-08-05 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090760-003 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2015-08-05 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090760-004 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | TABLET / ORAL | 2015-08-05 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090760-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2015-08-05 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090760-002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG | TABLET / ORAL | 2015-08-05 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090760-003 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2015-08-05 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090760-004 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | TABLET / ORAL | 2015-08-05 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090760-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2015-08-05 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090760-002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG | TABLET / ORAL | 2015-08-05 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090760-003 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2015-08-05 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090760-004 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | TABLET / ORAL | 2015-08-05 | 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 |
|---|---|---|---|---|---|---|
| Cetirizine Hydrochloride (Allergy) | CETIRIZINE HYDROCHLORIDE | Aurohealth LLC | c1ae7bb1-e154-4745-b01e-bc91d50d35c8 | 2026-05-25 | Warnings | 58602-861-21 58602-861-40 58602-861-29 58602-861 58602086121 58602086140 58602086129 20dddc76-5ac2-498d-bff3-2d722a58891e c1ae7bb1-e154-4745-b01e-bc91d50d35c8 |
Adverse event summaries are temporarily unavailable. Other product information remains available.