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
Use as directed per healthcare professional. 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 2 to under 6 years of age 2.5 mL once daily. If needed, dose can be increased to a maximum of 5 mL once daily or 2.5 mL every...
store between 20° to 25°C (68° to 77°F)
5 mg/5 mL Grape Flavor
For Hospital Use Only
LI1660 Rev.10/24
Drug Facts
Cetirizine HCl 5 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.
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 to this product occurs. Seek medical help right away.
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 2 to under 6 years of age | 2.5 mL once daily. If needed, dose can be increased to a maximum of 5 mL once daily or 2.5 mL every 12 hours. Do not give more than 5 mL in 24 hours. |
| children under 2 years of age | ask a doctor |
| consumers with liver or kidney disease | ask a doctor |
anhydrous citric acid, artificial grape flavor, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose
Dye Free, Gluten Free, Sugar Free
NDC 68094-004-62
5 mL per unit dose cup
Thirty (30) cups per shipper
Packaged By:
Precision Dose, Inc.
South Beloit, IL 61080
For inquiries call Precision Dose, Inc. at 1-800-397-9228 or email druginfo@precisiondose.com.
LI1660 Rev.10/24
| 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 |
|---|---|---|---|---|---|---|
| 68094-004-59 | Dye Free Childrens Cetirizine Hydrocholride | 5 mL in 1 CUP, UNIT-DOSE | SOLUTION | 5 | 3 | |
| 68094-004-62 | Dye Free Childrens Cetirizine Hydrocholride | 3 in 1 CASE | SOLUTION | 3 | 3 | |
| 68094-004-62 | Dye Free Childrens Cetirizine Hydrocholride | 10 in 1 TRAY | SOLUTION | 10 | 3 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68094-004-59 | ML - Milliliter | 68094-004 | 8e34b6b0-7978-4b06-ac60-a9f2264fb5a7 | 1 | 2016-12-07 |
| 68094-004-62 | ML - Milliliter | 68094-004 | 7d4d1ee8-9f5e-4229-9669-99813953d170 | 1 | 2016-12-07 |
| 0113-0503-26 | ML - Milliliter | 0113-0503 | 274a9c29-2d55-483e-9335-8f112c6b3723 | 1 | 2017-08-11 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 68094-004 | 68094-004-59, 68094-004-62 |
| 0113-0503 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Cetirizine Hydrochloride | 64O047KTOA | ACTIB |
| anhydrous citric acid | XF417D3PSL | IACT |
| propylene glycol | 6DC9Q167V3 | IACT |
| water | 059QF0KO0R | IACT |
| sodium benzoate | OJ245FE5EU | IACT |
| sorbitol | 506T60A25R | IACT |
| sucralose | 96K6UQ3ZD4 | 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 |
|---|---|---|---|---|---|---|---|
| A204226-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SOLUTION / ORAL | 2013-09-09 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A204226-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2013-09-09 | c2088c7a36db… | ||
| 2026-09-14 22:38:34 | 2026-08 | A204226-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2013-09-09 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A204226-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2013-09-09 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A204226-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2013-09-09 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204226-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2013-09-09 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A204226-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2013-09-09 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204226-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2013-09-09 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204226-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2013-09-09 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204226-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2013-09-09 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204226-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2013-09-09 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204226-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2013-09-09 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204226-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2013-09-09 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A204226-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2013-09-09 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204226-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2013-09-09 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A204226-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2013-09-09 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A204226-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2013-09-09 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A204226-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2013-09-09 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A204226-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SYRUP / ORAL | 2013-09-09 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A204226-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SYRUP / ORAL | 2013-09-09 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A204226-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SYRUP / ORAL | 2013-09-09 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A204226-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SYRUP / ORAL | 2013-09-09 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A204226-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SYRUP / ORAL | 2013-09-09 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A204226-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SYRUP / ORAL | 2013-09-09 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A204226-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SYRUP / ORAL | 2013-09-09 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A204226-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SYRUP / ORAL | 2013-09-09 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A204226-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SYRUP / ORAL | 2013-09-09 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A204226-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SYRUP / ORAL | 2013-09-09 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A204226-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SYRUP / ORAL | 2013-09-09 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A204226-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SYRUP / ORAL | 2013-09-09 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A204226-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SYRUP / ORAL | 2013-09-09 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A204226-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2013-09-09 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A204226-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SYRUP / ORAL | 2013-09-09 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A204226-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SYRUP / ORAL | 2013-09-09 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A204226-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SYRUP / ORAL | 2013-09-09 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A204226-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SYRUP / ORAL | 2013-09-09 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A204226-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SYRUP / ORAL | 2013-09-09 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A204226-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SYRUP / ORAL | 2013-09-09 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A204226-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SYRUP / ORAL | 2013-09-09 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A204226-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SYRUP / ORAL | 2013-09-09 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A204226-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SYRUP / ORAL | 2013-09-09 | 3a93d1ddd44b… |
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 |
|---|---|---|---|---|---|---|
| Good Sense Childrens All Day Allergy | CETIRIZINE HCL | L. Perrigo Company | e56edd0e-4873-41bc-a727-05c02ec943ed | 2026-04-20 | Warnings | 0113-0503 |
| Dye Free Childrens Cetirizine Hydrocholride | CETIRIZINE HCL | Precision Dose, Inc. | 6a7c4dff-66c6-4d0c-af10-d908c65a43be | 2025-02-12 | Warnings | 68094-004-62 68094-004-59 68094-004 68094000462 68094000459 16b6f804-4056-45a4-8764-8ca4256b3b43 6a7c4dff-66c6-4d0c-af10-d908c65a43be |
Adverse event summaries are temporarily unavailable. Other product information remains available.