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 | 209107 | derived:openfda.application_number |
| application number | ANDA209107 | openfda.application_number | |
| brand name | Cetirizine Hydrochloride (Allergy) | openfda.brand_name | |
| generic name | CETIRIZINE HYDROCHLORIDE | openfda.generic_name | |
| manufacturer name | Better Living Brands, LLC | openfda.manufacturer_name | |
| ndc | package | 21130-099-97 | openfda.package_ndc |
| ndc | product | 21130-099 | openfda.product_ndc |
| ndc11 | package | 21130009997 | derived:openfda.package_ndc |
| rxcui | 1014675 | openfda.rxcui | |
| spl id | b3b261a6-e56a-458a-a5a4-92bd95f4e2fc | id | |
| spl set id | f7deb8ca-4a26-aece-e053-6294a90aa685 | set_id | |
| unii | 64O047KTOA | openfda.unii |
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.