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 a 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
Store between 20° to 25°C (68° to 77°F)
Drug Facts
Cetirizine HCl 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.
Warnings
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.
Do not use
■ to prevent hives from any known cause such as:
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
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 | 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 |
Store between 20° to 25°C (68° to 77°F)
glacial acetic acid, glycerin, grape flavor, methylparaben, propylene glycol, propylparaben, purified water, sodium acetate, and sucrose
call toll-free 1-800-581-2528 weekdays
NDC 61037-480-22
Children’s Cetirizine Hydrochloride 1 mg/mL Oral Solution, USP
6 yrs. & older
Antihistamine
Grape Flavored
HIVES Relief
24 hour Relief of ITCHING
Due to Hives
4 fl. oz. (120 mL)
Dosing cup should be washed and left to air dry after each use. Do not use if seal on bottle is broken or missing.
Manufactured by:
Bajaj Medical, LLC
Chicago IL 60609, USA
Issued: 06/2025
NDC 61037-480-23
Children’s Cetirizine Hydrochloride 1 mg/mL Oral Solution, USP
6 yrs. & older
Antihistamine
Grape Flavored
HIVES Relief
24 hour Relief of ITCHING
Due to Hives
16 fl. oz. (480 mL)
Dosing cup should be washed and left to air dry after each use. Do not use if seal on bottle is broken or missing.
Manufactured by:
Bajaj Medical, LLC
Chicago IL 60609, USA
Issued: 06/2025
NDC 61037-480-24
Children’s Cetirizine Hydrochloride Oral Solution, USP
1 mg/mL
6 yrs. & older
Antihistamine
Grape Flavored
HIVES Relief
24 hour Relief of ITCHING
Due to Hives
8 fl. oz. (240 mL)
Dosing cup should be washed and left to air dry after each use. Do not use if seal on bottle is broken or missing.
Manufactured by:
Bajaj Medical, LLC
Chicago IL 60609, USA
Issued: 08/2025
NDC 61037-480-32
Children's
Cetirizine Hydrochloride Oral Solution, USP
5 mg/5 mL
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 6bd95106-a412-1dad-b9cc-4cb74bfb27ce | Product name | 2 | 20230315 |
| c505bb17-4ff9-45f9-ac2d-bb9c8c9d35be | Product name | 1 | 20200304 |
| a255659f-db40-429d-8c07-5f173f330d9c | Product name | 1 | 20190402 |
| 48747306-602a-42cc-957b-5b0c69158eee | Product name | 1 | 20180604 |
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
| 290f523a-f9db-9774-b5a9-e1f908ac1782 | Product name | 1 | 20150828 |
| 0ca1d589-929b-4b33-bc5b-1d84abdafa6a | Product name | 1 | 20150324 |
| fc363c46-397b-4476-ac0f-70e43e8e4592 | Product name | 1 | 20150324 |
| c6b65c52-69c7-df49-550a-a50c137f6218 | Product name | 1 | 20140508 |
| db5ebcdb-b6ae-21cd-4dc5-76cd84b5578b | Product name | 1 | 20140508 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 61037-480 | 61037-480-22, 61037-480-23, 61037-480-24, 61037-480-26, 61037-480-32 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CETIRIZINE HYDROCHLORIDE | 64O047KTOA | ACTIB |
| SUCROSE | C151H8M554 | IACT |
| SODIUM ACETATE | 4550K0SC9B | IACT |
| WATER | 059QF0KO0R | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| ACETIC ACID | Q40Q9N063P | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 4 | 2026-08-26 | daily-update | 2026-09-01 13:02:07 |
| 3 | 2025-08-05 | full-release | 2026-06-01 01:09:19 |
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 |
|---|---|---|---|---|---|---|---|
| A091327-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SOLUTION / ORAL | 2011-10-17 | ||
| A091327-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SOLUTION / ORAL | 2011-10-17 |
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 | A091327-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2011-10-17 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A091327-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | 2011-10-17 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A091327-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2011-10-17 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A091327-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | 2011-10-17 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A091327-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2011-10-17 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A091327-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | 2011-10-17 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091327-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2011-10-17 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091327-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | 2011-10-17 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A091327-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2011-10-17 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A091327-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | 2011-10-17 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091327-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2011-10-17 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091327-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | 2011-10-17 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091327-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2011-10-17 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091327-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | 2011-10-17 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091327-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2011-10-17 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091327-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | 2011-10-17 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091327-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2011-10-17 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091327-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | 2011-10-17 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091327-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2011-10-17 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091327-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | 2011-10-17 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091327-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2011-10-17 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091327-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | 2011-10-17 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A091327-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2011-10-17 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A091327-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | 2011-10-17 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091327-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2011-10-17 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091327-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | 2011-10-17 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091327-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2011-10-17 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091327-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | 2011-10-17 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091327-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2011-10-17 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091327-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | 2011-10-17 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A091327-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2011-10-17 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A091327-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | 2011-10-17 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A091327-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SYRUP / ORAL | 2011-10-17 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A091327-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SYRUP / ORAL | 2011-10-17 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A091327-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SYRUP / ORAL | 2011-10-17 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A091327-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SYRUP / ORAL | 2011-10-17 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A091327-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SYRUP / ORAL | 2011-10-17 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A091327-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SYRUP / ORAL | 2011-10-17 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A091327-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SYRUP / ORAL | 2011-10-17 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A091327-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SYRUP / ORAL | 2011-10-17 | 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 |
|---|---|---|---|---|---|---|
| CETIRIZINE HYDROCHLORIDE | CETIRIZINE HYDROCHLORIDE | BAJAJ MEDICAL, LLC | 36b24a3c-6284-5a6d-e063-6394a90a7743 | 2026-08-26 | Warnings | 61037-480 |
| CETIRIZINE HYDROCHLORIDE | CETIRIZINE HYDROCHLORIDE | BAJAJ MEDICAL, LLC | 36b6d0e4-8da5-9df5-e063-6294a90af326 | 2026-08-26 | Warnings | 61037-480-32 61037-480-22 61037-480-24 61037-480-23 61037-480-26 61037-480 61037048026 61037048024 61037048023 61037048022 61037048032 36b6d0e4-8da5-9df5-e063-6294a90af326 |
Adverse event summaries are temporarily unavailable. Other product information remains available.