| Product NDC: | 16853-1305 |
| Proprietary Name: | ALLEROFF |
| Non Proprietary Name: | Cetirizine Hydrochloride |
| Active Ingredient(s): | 10 mg/1 & nbsp; Cetirizine Hydrochloride |
| Administration Route(s): | ORAL |
| Dosage Form(s): | TABLET |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 16853-1305 |
| Labeler Name: | Corporacion Infarmasa |
| Product Type: | HUMAN OTC DRUG |
| FDA Application Number: | NDA019835 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20100101 |
| Package NDC: | 16853-1305-3 |
| Package Description: | 2 TABLET in 1 BLISTER PACK (16853-1305-3) |
| NDC Code | 16853-1305-3 |
| Proprietary Name | ALLEROFF |
| Package Description | 2 TABLET in 1 BLISTER PACK (16853-1305-3) |
| Product NDC | 16853-1305 |
| Product Type Name | HUMAN OTC DRUG |
| Non Proprietary Name | Cetirizine Hydrochloride |
| Dosage Form Name | TABLET |
| Route Name | ORAL |
| Start Marketing Date | 20100101 |
| Marketing Category Name | NDA |
| Labeler Name | Corporacion Infarmasa |
| Substance Name | CETIRIZINE HYDROCHLORIDE |
| Strength Number | 10 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes |