Application Nr Approved Date Route Status External Links
ANDA090254 2008-04-09 Oral OTC Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Purpose Antihistamine

All Formulated Excipients (8 Total)

Name Structure Kind Function Status
1. Acetic Acid ACETIC ACID Molecular B&N-Buffer & neutralizing agent , FEED-Feed additives FS-Substances permitted as optional ingredient in a standardized food.
2. Glycerin GLYCERIN Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
3. Methylparaben METHYLPARABEN Molecular PRES-Chemical preservative REG-Food additives for which a petition has been filed and a regulation issued.
4. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
5. Propylparaben PROPYLPARABEN Molecular PRES-Chemical preservative REG-Food additives for which a petition has been filed and a regulation issued.
6. Water WATER Molecular
7. Sodium Acetate SODIUM ACETATE Molecular BC-Boiler compound , B&N-Buffer & neutralizing agent GRAS-Generally recognized as safe.
8. Sucrose SUCROSE Molecular NUTRS-Nutritive Sweetener GRAS-Generally recognized as safe.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Cetirizine Hydrochloride CETIRIZINE HYDROCHLORIDE ZINC19364229

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