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 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 ...
• 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
Cetirizine HCl 5 mg
Antihistamine
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.
liver or kidney disease. Your doctor should determine if you need a different dose.
taking tranquilizers or sedatives.
an allergic reaction to this product occurs. Seek medical help right away.
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 |
artificial grape flavor, glacial acetic acid, glycerin, methylparaben, natural banana flavor, propylene glycol, propylparaben, purified water, sodium acetate, sucrose
1-800-719-9260
Product: 50090-4173
NDC: 50090-4173-0 118 mL in a BOTTLE / 1 in a CARTON
| Class | Version | Type | Effective |
|---|---|---|---|
| CETIRIZINE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
| 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 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50090-4173-0 | 2023-01-30 | C162847 | 48780-1 | f386c649-9979-0266-e053-dadaa90a7c1a | Perrigo Children's Cetirizine Hydrochloride Oral Solution 1 mg/mL Drug Facts |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50090-4173-0 | cetirizine hydrochloride | 1 in 1 CARTON | SOLUTION | 1 | 1 | |
| 50090-4173-0 | cetirizine hydrochloride | 118 mL in 1 BOTTLE | SOLUTION | 118 | 1 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50090-4173 | CETIRIZINE HYDROCHLORIDE SOLUTION [A-S MEDICATION SOLUTIONS] | 1 | Legacy NDC, 2 package rows | 20190326_2b348ce4-7c6e-488f-a781-17b26a170762.zip |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 45802-974-26 | ML - Milliliter | 45802-974 | d68604aa-8f6d-4382-b79c-5482855799c4 | 1 | 2012-07-24 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 50090-4173 | 50090-4173-0 |
| 45802-974 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CETIRIZINE HYDROCHLORIDE | 64O047KTOA | ACTIB |
| ACETIC ACID | Q40Q9N063P | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM ACETATE | 4550K0SC9B | IACT |
| SUCROSE | C151H8M554 | 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 |
|---|---|---|---|---|---|---|---|
| A090254-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SOLUTION / ORAL | 2008-04-09 | ||
| A090254-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SOLUTION / ORAL | 2008-04-09 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A090254-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | 2008-04-09 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A090254-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2008-04-09 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A090254-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | 2008-04-09 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A090254-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2008-04-09 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A090254-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | 2008-04-09 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A090254-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2008-04-09 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090254-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | 2008-04-09 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090254-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2008-04-09 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A090254-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | 2008-04-09 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A090254-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2008-04-09 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090254-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | 2008-04-09 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090254-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2008-04-09 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090254-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | 2008-04-09 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090254-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2008-04-09 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090254-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | 2008-04-09 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090254-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2008-04-09 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090254-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | 2008-04-09 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090254-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2008-04-09 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090254-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | 2008-04-09 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090254-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2008-04-09 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090254-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | 2008-04-09 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090254-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2008-04-09 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A090254-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | 2008-04-09 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A090254-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2008-04-09 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090254-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | 2008-04-09 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090254-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2008-04-09 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090254-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | 2008-04-09 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090254-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2008-04-09 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090254-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | 2008-04-09 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090254-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2008-04-09 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A090254-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | 2008-04-09 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A090254-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2008-04-09 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090254-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SYRUP / ORAL | 2008-04-09 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090254-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SYRUP / ORAL | 2008-04-09 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A090254-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SYRUP / ORAL | 2008-04-09 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A090254-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SYRUP / ORAL | 2008-04-09 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A090254-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SYRUP / ORAL | 2008-04-09 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A090254-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SYRUP / ORAL | 2008-04-09 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A090254-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SYRUP / ORAL | 2008-04-09 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A090254-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SYRUP / ORAL | 2008-04-09 | 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 | Padagis Israel Pharmaceuticals Ltd | c2cf555d-986c-4e89-ac4f-938e92c418e2 | 2025-01-20 | Warnings | 45802-974 |
| 47910875-0f88-46f7-a5c8-7ef532e211e9 | 2b348ce4-7c6e-488f-a781-17b26a170762 | 2019-03-22 | Warnings | 47910875-0f88-46f7-a5c8-7ef532e211e9 2b348ce4-7c6e-488f-a781-17b26a170762 |
Adverse event summaries are temporarily unavailable. Other product information remains available.