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.
■ use only with enclosed dosing cup ■ find right dose on chart below ■ mL = milliliter adults and children 6 years and over 5 mL or 10 mL once daily depending upon severity of symptoms; do not take more than 10 mL in 24 hours. adults 65 years and over 5 mL once daily; do not take more than 5 mL in 24 hours. 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 carton is opened or if bottle wrap imprinted with “Sealed For Your Safety” is broken or missing
Drug Facts
Cetirizine HCI 5 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:
■ trouble swallowing
■ dizziness or loss of consciousness
■ swelling of tongue
■ swelling in or around mouth
■ trouble speaking
■ drooling
■ wheezing or problems breathing
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.
■ to
prevent hives from any known cause such as:
■ 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.
■ 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.
■ hives that are an unusual color, look bruised or blistered
■ hives that do not itch
Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.
When using this product
■ drowsiness may occur
■ avoid alcoholic drinks
■ alcohol, sedatives, and tranquilizers may increase drowsiness
■ be careful when driving a motor vehicle or operating machinery
Stop use and ask a doctor if
■ an allergic reaction to this product occurs. Seek medical help right away.
■ symptoms do not improve after 3 days of treatment
■ the hives have lasted more than 6 weeks
If pregnant or breast-feeding:
■ if breast-feeding: not recommended
■ if pregnant: ask a health professional before use.
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)
■ use only with enclosed dosing cup
■ find right dose on chart below
■ mL = milliliter
| adults and children 6 years and over | 5 mL or 10 mL once daily depending upon severity of symptoms; do not take more than 10 mL in 24 hours. |
| adults 65 years and over | 5 mL once daily; do not take more than 5 mL in 24 hours. |
| 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 carton is opened or if bottle wrap imprinted with “Sealed For Your Safety” is broken or missing
Inactive ingredients anhydrous citric acid, flavors, propylene glycol, purified water, sodium benzoate,
sorbitol solution, sucralose
Questions? call 1-800-343-7805 (toll-free) or 215-273-8755 (collect)
NDC 50580-128-04
Children’s
ZYRTEC®HIVES
Cetirizine HCl oral solution
1 mg/ml/antihistamine
Hives Relief
6 yrs & old
HIVES RELIEF
24 Hour relief
Reduces Itching Due to Hives
Reduces Hives
Grape Flavor
4 fl oz (118ml)
Dosing cup included
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1014673 | cetirizine HCl 5 MG in 5 mL Oral Solution | PSN | 2 |
| 1020021 | ZyrTEC 5 MG in 5 mL Oral Solution | PSN | 2 |
| 1020021 | cetirizine hydrochloride 1 MG/ML Oral Solution [Zyrtec] | SBD | 2 |
| 1014673 | cetirizine hydrochloride 1 MG/ML Oral Solution | SCD | 2 |
| 1014673 | cetirizine HCl 1 MG/ML Oral Syrup | SY | 2 |
| 1014673 | cetirizine HCl 5 MG per 5 ML Oral Solution | SY | 2 |
| 1020021 | Children's Zyrtec 5 MG per 5 ML Medicated Spoon | SY | 2 |
| 1020021 | Zyrtec 1 MG/ML Oral Solution | SY | 2 |
| 1020021 | Zyrtec Children's 5 MG per 5 ML Syrup | SY | 2 |
| Class | Version | Type | Effective |
|---|---|---|---|
| CETIRIZINE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e2db08c6-133f-4f4f-afb4-e90a2418d6f6 | Product name | 1 | 20230320 |
| ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906 | Product name | 7 | 20210625 |
| f52be47f-7aa7-46c0-b1fa-50c18dd50206 | Product name | 1 | 20201029 |
| c505bb17-4ff9-45f9-ac2d-bb9c8c9d35be | Product name | 1 | 20200304 |
| a255659f-db40-429d-8c07-5f173f330d9c | Product name | 1 | 20190402 |
| 11ed6f83-cdd2-4637-8379-b1a1d3ae3cde | Product name | 1 | 20181101 |
| 86c45a79-b9f0-4476-a27c-6e10db098497 | Product name | 1 | 20180125 |
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50580-128-04 | ZYRTEC HIVES | 1 in 1 CARTON | SOLUTION | 1 | 2 | |
| 50580-128-04 | ZYRTEC HIVES | 118 mL in 1 BOTTLE | SOLUTION | 118 | 2 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 50580-128 | 50580-128-04 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| SORBITOL SOLUTION | 8KW3E207O2 | IACT |
| WATER | 059QF0KO0R | 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 |
|---|---|---|---|---|---|---|---|
| N022155-001 | CHILDREN'S ZYRTEC HIVES | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SOLUTION / ORAL | RLD, RS | 2007-11-16 | |
| N022155-002 | CHILDREN'S ZYRTEC ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SOLUTION / ORAL | RLD, RS | 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 | N022155-001 | CHILDREN'S ZYRTEC HIVES | 5MG/5ML | SOLUTION / ORAL | RLD, RS | 2007-11-16 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022155-002 | CHILDREN'S ZYRTEC ALLERGY | 5MG/5ML | SOLUTION / ORAL | RLD, RS | 2007-11-16 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N022155-001 | CHILDREN'S ZYRTEC HIVES | 5MG/5ML | SOLUTION / ORAL | RLD, RS | 2007-11-16 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022155-002 | CHILDREN'S ZYRTEC ALLERGY | 5MG/5ML | SOLUTION / ORAL | RLD, RS | 2007-11-16 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022155-001 | CHILDREN'S ZYRTEC HIVES | 5MG/5ML | SOLUTION / ORAL | RLD, RS | 2007-11-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022155-002 | CHILDREN'S ZYRTEC ALLERGY | 5MG/5ML | SOLUTION / ORAL | RLD, RS | 2007-11-16 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022155-001 | CHILDREN'S ZYRTEC HIVES | 5MG/5ML | SOLUTION / ORAL | RLD, RS | 2007-11-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022155-002 | CHILDREN'S ZYRTEC ALLERGY | 5MG/5ML | SOLUTION / ORAL | RLD, RS | 2007-11-16 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022155-001 | CHILDREN'S ZYRTEC HIVES | 5MG/5ML | SOLUTION / ORAL | RLD, RS | 2007-11-16 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022155-002 | CHILDREN'S ZYRTEC ALLERGY | 5MG/5ML | SOLUTION / ORAL | RLD, RS | 2007-11-16 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022155-001 | CHILDREN'S ZYRTEC HIVES | 5MG/5ML | SOLUTION / ORAL | RLD, RS | 2007-11-16 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022155-002 | CHILDREN'S ZYRTEC ALLERGY | 5MG/5ML | SOLUTION / ORAL | RLD, RS | 2007-11-16 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022155-001 | CHILDREN'S ZYRTEC HIVES | 5MG/5ML | SOLUTION / ORAL | RLD, RS | 2007-11-16 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022155-002 | CHILDREN'S ZYRTEC ALLERGY | 5MG/5ML | SOLUTION / ORAL | RLD, RS | 2007-11-16 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022155-001 | CHILDREN'S ZYRTEC HIVES | 5MG/5ML | SOLUTION / ORAL | RLD, RS | 2007-11-16 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022155-002 | CHILDREN'S ZYRTEC ALLERGY | 5MG/5ML | SOLUTION / ORAL | RLD, RS | 2007-11-16 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022155-001 | CHILDREN'S ZYRTEC HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | RLD, RS | 2007-11-16 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022155-002 | CHILDREN'S ZYRTEC ALLERGY | 5MG/5ML | SOLUTION / ORAL | RLD, RS | 2007-11-16 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022155-001 | CHILDREN'S ZYRTEC HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | RLD, RS | 2007-11-16 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022155-002 | CHILDREN'S ZYRTEC ALLERGY | 5MG/5ML | SOLUTION / ORAL | RLD, RS | 2007-11-16 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022155-001 | CHILDREN'S ZYRTEC HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | RLD, RS | 2007-11-16 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022155-002 | CHILDREN'S ZYRTEC ALLERGY | 5MG/5ML | SOLUTION / ORAL | RLD, RS | 2007-11-16 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N022155-001 | CHILDREN'S ZYRTEC HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | RLD, RS | 2007-11-16 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N022155-002 | CHILDREN'S ZYRTEC ALLERGY | 5MG/5ML | SOLUTION / ORAL | RLD, RS | 2007-11-16 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022155-001 | CHILDREN'S ZYRTEC HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | RLD, RS | 2007-11-16 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022155-002 | CHILDREN'S ZYRTEC ALLERGY | 5MG/5ML | SOLUTION / ORAL | RLD, RS | 2007-11-16 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022155-001 | CHILDREN'S ZYRTEC HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | RLD, RS | 2007-11-16 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022155-002 | CHILDREN'S ZYRTEC ALLERGY | 5MG/5ML | SOLUTION / ORAL | RLD, RS | 2007-11-16 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022155-001 | CHILDREN'S ZYRTEC HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | RLD, RS | 2007-11-16 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022155-002 | CHILDREN'S ZYRTEC ALLERGY | 5MG/5ML | SOLUTION / ORAL | RLD, RS | 2007-11-16 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N022155-001 | CHILDREN'S ZYRTEC HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | RLD, RS | 2007-11-16 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N022155-002 | CHILDREN'S ZYRTEC ALLERGY | 5MG/5ML | SOLUTION / ORAL | RLD, RS | 2007-11-16 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022155-001 | CHILDREN'S ZYRTEC HIVES RELIEF | 5MG/5ML | SYRUP / ORAL | RLD, RS | 2007-11-16 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022155-002 | CHILDREN'S ZYRTEC ALLERGY | 5MG/5ML | SYRUP / ORAL | RLD, RS | 2007-11-16 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N022155-001 | CHILDREN'S ZYRTEC HIVES RELIEF | 5MG/5ML | SYRUP / ORAL | RLD, RS | 2007-11-16 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N022155-002 | CHILDREN'S ZYRTEC ALLERGY | 5MG/5ML | SYRUP / ORAL | RLD, RS | 2007-11-16 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N022155-001 | CHILDREN'S ZYRTEC HIVES RELIEF | 5MG/5ML | SYRUP / ORAL | RLD, RS | 2007-11-16 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N022155-002 | CHILDREN'S ZYRTEC ALLERGY | 5MG/5ML | SYRUP / ORAL | RLD, RS | 2007-11-16 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N022155-001 | CHILDREN'S ZYRTEC HIVES RELIEF | 5MG/5ML | SYRUP / ORAL | RLD, RS | 2007-11-16 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N022155-002 | CHILDREN'S ZYRTEC ALLERGY | 5MG/5ML | SYRUP / ORAL | RLD, RS | 2007-11-16 | 74a2ff9319b5… |
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 | 31400cb2-fe85-ef74-e063-6294a90a11fb | 2025-06-16 | Warnings | 50580-128-04 50580-128 50580012804 37b3c47a-f31a-20f4-e063-6294a90ab07a 31400cb2-fe85-ef74-e063-6294a90a11fb |
Adverse event summaries are temporarily unavailable. Other product information remains available.