Indications and uses
reduces hives and relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occurring.
reduces hives and relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occurring.
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
Other information store between 20° to 25°C (68° to 77°F) do not use if foil inner seal imprinted with “Sealed For Your Safety” is broken or missing meets USP Dissolution Test 2
Drug Facts
Cetirizine HCl 10 mg
Antihistamine
reduces hives and relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occurring.
Severe Allergy Warning: Get emergency help immediately if you have hives along with any of the following symptoms:
These symptoms may be signs of anaphylactic shock.
This condition can be life threatening if not treated by a health professional
immediately. Symptoms of anaphylactic shock may occur when hives first appear or up to a few hours later.
Not a Substitute for Epinephrine. If your doctor has prescribed an epinephrine injector for "anaphylaxis" or severe allergy symptoms that could occur with your hives, never use this product as a substitute for the epinephrine injector. If you have been prescribed an epinephrine injector, you should carry it with you at all times.
-foods
-insect stings
-medicines
-latex or rubber gloves
because this product will not stop hives from occurring. Avoiding the cause of your hives is the only way to prevent them. Hives can sometimes be serious. If you do not know the cause of your hives, see your doctor for a medical exam. Your doctor may be able to help you find a cause.
Ask a doctor before use if you have
Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.
When using this product
Stop use and ask a doctor if
If pregnant or breast-feeding:
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)
| 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 |
Other information
colloidal silicon dioxide, croscarmellose sodium,hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide
Questions? call 1-800-343-7805 (toll-free) or 215-273-8755 (collect).
Original Prescription Strength
NDC 50580-116-30
ZYRTEC
® HIVES
Cetirizine HCl tablets
10mg/antihistamine
Hives Relief
24 Hour relief
Reduces Hives
Reduces Itching Due to Hives
30 Tablets 10 mg each
Actual Size
30 TABLETS
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1014678 | cetirizine HCl 10 MG Oral Tablet | PSN | 2 |
| 1020026 | ZyrTEC 10 MG Oral Tablet | PSN | 2 |
| 1020026 | cetirizine hydrochloride 10 MG Oral Tablet [Zyrtec] | SBD | 2 |
| 1014678 | cetirizine hydrochloride 10 MG Oral Tablet | SCD | 2 |
| 1014678 | cetirizine HCl 10 MG Oral Tablet | SY | 2 |
| 1020026 | Zyrtec (cetirizine dihydrochloride 10 MG) Oral Tablet | SY | 2 |
| 1020026 | Zyrtec 10 MG Oral Tablet | SY | 2 |
| 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 |
|---|---|---|---|---|---|---|
| 50580-116-30 | ZYRTEC Hives | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | 2 | |
| 50580-116-30 | ZYRTEC Hives | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 2 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 50580-116 | 50580-116-30 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| HYPROMELLOSES | 3NXW29V3WO | IACT |
| LACTOSE MONOHYDRATE | EWQ57Q8I5X | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| CETIRIZINE HYDROCHLORIDE | 64O047KTOA | ACTIB |
| CROSCARMELLOSE SODIUM | M28OL1HH48 | 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 |
|---|---|---|---|---|---|---|---|
| N019835-003 | ZYRTEC ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET / ORAL | RLD | 2007-11-16 | |
| N019835-004 | ZYRTEC ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | RLD, RS | 2007-11-16 | |
| N019835-005 | ZYRTEC HIVES | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET / ORAL | RLD | 2007-11-16 | |
| N019835-006 | ZYRTEC HIVES | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | RLD | 2007-11-16 |
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 | N019835-003 | ZYRTEC ALLERGY | 5MG | TABLET / ORAL | RLD | 2007-11-16 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N019835-004 | ZYRTEC ALLERGY | 10MG | TABLET / ORAL | RLD, RS | 2007-11-16 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N019835-005 | ZYRTEC HIVES | 5MG | TABLET / ORAL | RLD | 2007-11-16 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N019835-006 | ZYRTEC HIVES | 10MG | TABLET / ORAL | RLD | 2007-11-16 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N019835-003 | ZYRTEC ALLERGY | 5MG | TABLET / ORAL | RLD | 2007-11-16 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N019835-004 | ZYRTEC ALLERGY | 10MG | TABLET / ORAL | RLD, RS | 2007-11-16 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N019835-005 | ZYRTEC HIVES | 5MG | TABLET / ORAL | RLD | 2007-11-16 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N019835-006 | ZYRTEC HIVES | 10MG | TABLET / ORAL | RLD | 2007-11-16 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N019835-003 | ZYRTEC ALLERGY | 5MG | TABLET / ORAL | RLD | 2007-11-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N019835-004 | ZYRTEC ALLERGY | 10MG | TABLET / ORAL | RLD, RS | 2007-11-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N019835-005 | ZYRTEC HIVES | 5MG | TABLET / ORAL | RLD | 2007-11-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N019835-006 | ZYRTEC HIVES | 10MG | TABLET / ORAL | RLD | 2007-11-16 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019835-003 | ZYRTEC ALLERGY | 5MG | TABLET / ORAL | RLD | 2007-11-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019835-004 | ZYRTEC ALLERGY | 10MG | TABLET / ORAL | RLD, RS | 2007-11-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019835-005 | ZYRTEC HIVES | 5MG | TABLET / ORAL | RLD | 2007-11-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019835-006 | ZYRTEC HIVES | 10MG | TABLET / ORAL | RLD | 2007-11-16 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N019835-003 | ZYRTEC ALLERGY | 5MG | TABLET / ORAL | RLD | 2007-11-16 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N019835-004 | ZYRTEC ALLERGY | 10MG | TABLET / ORAL | RLD, RS | 2007-11-16 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N019835-005 | ZYRTEC HIVES | 5MG | TABLET / ORAL | RLD | 2007-11-16 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N019835-006 | ZYRTEC HIVES | 10MG | TABLET / ORAL | RLD | 2007-11-16 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019835-003 | ZYRTEC ALLERGY | 5MG | TABLET / ORAL | RLD | 2007-11-16 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019835-004 | ZYRTEC ALLERGY | 10MG | TABLET / ORAL | RLD, RS | 2007-11-16 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019835-005 | ZYRTEC HIVES | 5MG | TABLET / ORAL | RLD | 2007-11-16 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019835-006 | ZYRTEC HIVES | 10MG | TABLET / ORAL | RLD | 2007-11-16 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019835-003 | ZYRTEC ALLERGY | 5MG | TABLET / ORAL | RLD | 2007-11-16 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019835-004 | ZYRTEC ALLERGY | 10MG | TABLET / ORAL | RLD, RS | 2007-11-16 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019835-005 | ZYRTEC HIVES | 5MG | TABLET / ORAL | RLD | 2007-11-16 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019835-006 | ZYRTEC HIVES | 10MG | TABLET / ORAL | RLD | 2007-11-16 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019835-003 | ZYRTEC ALLERGY | 5MG | TABLET / ORAL | RLD | 2007-11-16 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019835-004 | ZYRTEC ALLERGY | 10MG | TABLET / ORAL | RLD, RS | 2007-11-16 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019835-005 | ZYRTEC HIVES | 5MG | TABLET / ORAL | RLD | 2007-11-16 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019835-006 | ZYRTEC HIVES | 10MG | TABLET / ORAL | RLD | 2007-11-16 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019835-003 | ZYRTEC ALLERGY | 5MG | TABLET / ORAL | RLD | 2007-11-16 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019835-004 | ZYRTEC ALLERGY | 10MG | TABLET / ORAL | RLD, RS | 2007-11-16 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019835-005 | ZYRTEC HIVES RELIEF | 5MG | TABLET / ORAL | RLD | 2007-11-16 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019835-006 | ZYRTEC HIVES RELIEF | 10MG | TABLET / ORAL | RLD | 2007-11-16 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019835-003 | ZYRTEC ALLERGY | 5MG | TABLET / ORAL | RLD | 2007-11-16 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019835-004 | ZYRTEC ALLERGY | 10MG | TABLET / ORAL | RLD, RS | 2007-11-16 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019835-005 | ZYRTEC HIVES RELIEF | 5MG | TABLET / ORAL | RLD | 2007-11-16 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019835-006 | ZYRTEC HIVES RELIEF | 10MG | TABLET / ORAL | RLD | 2007-11-16 | 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 |
|---|---|---|---|---|---|---|
| ZYRTEC Hives | CETIRIZINE HYDROCHLORIDE | Kenvue Brands LLC | 31136e3a-94fa-0860-e063-6394a90a008d | 2025-06-16 | Warnings | 50580-116-30 50580-116 50580011630 37b38291-50c9-00c9-e063-6394a90a83ef 31136e3a-94fa-0860-e063-6394a90a008d |
Adverse event summaries are temporarily unavailable. Other product information remains available.