warnings
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.
Cross-check layer: This is openFDA JSON-derived label data. Use the corresponding DailyMed SPL as the canonical label.
Verified complete openFDA source JSON
| Harmonized routes |
|---|
| ORAL |
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| application applno | ANDA | 090750 | derived:openfda.application_number |
| application number | ANDA090750 | openfda.application_number | |
| brand name | CHILDRENS ALLERGY RELIEF | openfda.brand_name | |
| generic name | CETIRIZINE HYDROCHLORIDE | openfda.generic_name | |
| manufacturer name | Fred's, Inc. | openfda.manufacturer_name | |
| ndc | package | 55315-354-31 | openfda.package_ndc |
| ndc | product | 55315-354 | openfda.product_ndc |
| ndc11 | package | 55315035431 | derived:openfda.package_ndc |
| rxcui | 1014673 | openfda.rxcui | |
| spl id | 17d2db07-4de0-4e02-8e2e-0082c275faab | id | |
| spl set id | 55e799b2-e325-4286-aa9a-b88e99ab1146 | set_id | |
| unii | 64O047KTOA | openfda.unii |
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.