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
Major Pharmaceuticals Children’s Cetirizine Hydrochloride Oral Solution Drug Facts
- Manufacturer
- ATLANTIC BIOLOGICALS CORP.
- Effective date
- 2026-09-01
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- daily-update
- Hydrated at
- 2026-09-03 03:02:28
Label at a glance#
Productchildrens cetirizine hydrochloride
Active ingredientCETIRIZINE HYDROCHLORIDE
Label structure9 sections
Dosage and administration
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 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 d...
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredient (in each 5 mL)
Cetirizine HCl 5 mg
Purpose
Antihistamine
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
Warnings
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.
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.
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)
Directions
- 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 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 |
Other information
- store between 20° to 25°C (68° to 77°F)
- do not use if carton is opened, or if printed neckband is broken or missing
- see bottom panel for lot number and expiration date
Inactive ingredients
anhydrous citric acid, artificial grape flavor, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose
Questions or comments?
DISTRIBUTED BY:
ATLANTIC BIOLOGICALS CORP.
MIAMI, FL 33179
HOW SUPPLIED SECTION
Cetirizine HCL Oral Suspension 1 mg/ mL is a grape-flavored suspension.
Available in these presentations:
17856-6765-01 - 5 mL (CUP) 72 ct UD
17856-6765-03 - 2.5 mL (Enfit Syringe) 120 ct UD
17856-6765-09 - 2.5 mL (Enfit Syringe) 90 ct UD
Store between 20° to 25°C (68° to 77°F). Excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].
Package/Label Principal Display Panel
Children’s Cetirizine Hydrochloride Oral Solution 1 mg/mL
Antihistamine
ALLERGY
INDOOR & OUTDOOR ALLERGIES
24 HOUR RELIEF OF:
Sneezing / Runny Nose
Itchy, Watery Eyes / Itchy Throat or Nose
2yrs & older
Dosing Cup Included
Dye-Free
Sugar-Free
Grape Flavored Syrup
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | Data Matrix | (01)00317856676519(21)XXXXXXXXXXX(10)XXXXXXXXXX(17)010101 | GTIN-14: 00317856676519 GTIN-12: 317856676519 UPC-A: 317856676519 EAN-13: 0317856676519 GTIN storage (14 digits): 00317856676519 | 17856-6765-01 Rev. 1 Case Label.jpg |
| Barcode | Data Matrix | (01)00317856676533(17)261104(10)026194(21)02619402 | GTIN-14: 00317856676533 GTIN-12: 317856676533 UPC-A: 317856676533 EAN-13: 0317856676533 GTIN storage (14 digits): 00317856676533 | 17856-6765-03 Rev. Case Label.jpg |
| Barcode | Data Matrix | (01)00317856676595(17)270228(10)027361(21)0273611000 | GTIN-14: 00317856676595 GTIN-12: 317856676595 UPC-A: 317856676595 EAN-13: 0317856676595 GTIN storage (14 digits): 00317856676595 | 17856-6765-09 Rev. 1 Case Label.jpg |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| c505bb17-4ff9-45f9-ac2d-bb9c8c9d35be | Product name | 1 | 20200304 |
| a255659f-db40-429d-8c07-5f173f330d9c | Product name | 1 | 20190402 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0904-6765-20 | ML - Milliliter | 0904-6765 | 384cd178-ca8b-4538-8460-fa0b2cddbe49 | 1 | 2018-11-06 |
Products#
Every source-derived product name is available through these pages.
- childrens cetirizine hydrochloride
- Cetirizine HCl
- CETIRIZINE HYDROCHLORIDE
- CETIRIZINE
- ANHYDROUS CITRIC ACID
- PROPYLENE GLYCOL
- WATER
- SODIUM BENZOATE
- SORBITOL
- SUCRALOSE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 17856-6765 | 17856-6765-1, 17856-6765-3, 17856-6765-9 |
| 0904-6765 |
Ingredients#
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 |
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 2 | 2026-05-01 | full-release | 2026-06-01 01:55:59 |
Orange Book application contexts#
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book products#
| 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 Orange Book product history#
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 | 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… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A204226-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SYRUP / ORAL | 2013-09-09 | f41ea6bd6efb… |
openFDA label cross-check#
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 |
|---|---|---|---|---|---|---|
| childrens cetirizine hydrochloride | CETIRIZINE HCL | ATLANTIC BIOLOGICALS CORP. | cb47e536-8eed-4a32-b9c2-e8535fb93886 | 2026-09-01 | Warnings | 17856-6765-3 17856-6765-9 17856-6765-1 17856-6765 17856676503 17856676501 17856676509 5a6cbd56-2b11-2893-e063-6394a90a1278 cb47e536-8eed-4a32-b9c2-e8535fb93886 |
| childrens cetirizine hydrochloride | CETIRIZINE HCL | Major Pharmaceuticals | db297aa4-4384-48f2-b2bd-c842efc8a844 | 2026-02-13 | Warnings | 0904-6765 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.