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
Active Ingredients (in each tablet) Purpose
Cetirizine HCl USP 10 mg................................................................Antihistimine
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.
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.
Stop use and ask a doctor if an allergic reaction tothis product occurs. Seek medical help right away.
In case of overdose, get medical help or contact Poison Control Center right away.
| 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 at 20° to 25°C (68° to 77°F)
[See USP Controlled Room Temperature]
Hypromellose, lactose, magnesium stearate, maize starch, polyethylene glycol, povidone, titanium dioxide.
Call 1-844-874-7464
Repackaged and Distributed By:
Remedy Repack, Inc.
625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762
DRUG: Cetirizine Hydrochloride
GENERIC: Cetirizine Hydrochloride
DOSAGE: TABLET
ADMINSTRATION: ORAL
NDC: 70518-0182-0
NDC: 70518-0182-1
NDC: 70518-0182-2
NDC: 70518-0182-3
NDC: 70518-0182-4
NDC: 70518-0182-5
NDC: 70518-0182-6
COLOR: white
SHAPE: BULLET
SCORE: No score
SIZE: 8 mm
IMPRINT: CTN;10
PACKAGING: 30 in 1 BLISTER PACK
PACKAGING: 30 in 1 BOTTLE PLASTIC
PACKAGING: 100 in 1 BOTTLE PLASTIC
PACKAGING: 14 in 1 BOTTLE PLASTIC
PACKAGING: 5 in 1 BOTTLE PLASTIC
PACKAGING: 90 in 1 BOTTLE PLASTIC
PACKAGING: 7 in 1 BOTTLE PLASTIC
ACTIVE INGREDIENT(S):
INACTIVE INGREDIENT(S):
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 16571-402-10 | EA - Each | 16571-402 | 2524d8a5-6929-4792-b28d-276f9c97b20e | 1 | 2012-07-24 |
| 16571-402-50 | EA - Each | 16571-402 | a6cd2ed0-855f-460d-a2cb-5f7054e8e849 | 1 | 2013-02-13 |
| 16571-402-90 | EA - Each | 16571-402 | d8ef7ec6-0a15-4216-95b1-e5296fd2d242 | 1 | 2012-07-24 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 70518-0182 | 70518-0182-0, 70518-0182-1, 70518-0182-2, 70518-0182-3, 70518-0182-4, 70518-0182-5, 70518-0182-6 |
| 16571-402 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| HYPROMELLOSES | 3NXW29V3WO | IACT |
| LACTOSE | J2B2A4N98G | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| POLYETHYLENE GLYCOL | 3WJQ0SDW1A | IACT |
| POVIDONE | FZ989GH94E | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| CETIRIZINE HYDROCHLORIDE | 64O047KTOA | ACTIB |
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 |
|---|---|---|---|---|---|---|
| Cetirizine Hydrochloride | CETIRIZINE HYDROCHLORIDE | Rising Pharma Holdings, Inc. | 5481ccb3-b311-4b25-b923-4fe8522ea92b | 2025-11-05 | Warnings | 16571-402 |
| 079b8ca4-702b-6688-e063-6394a90aa63d | da2d7780-2c75-46f1-af2d-2d2bb371a993 | 2023-10-13 | Warnings | da2d7780-2c75-46f1-af2d-2d2bb371a993 |
Adverse event summaries are temporarily unavailable. Other product information remains available.