Application Nr Approved Date Route Status External Links
NDA022429 2009-07-23 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. Gelatin GELATIN Unresolved
2. Glycerin GLYCERIN Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
3. Mannitol MANNITOL Molecular NUTR-Nutrient GRAS-Generally recognized as safe.
4. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
5. Water WATER Molecular
6. Sodium Hydroxide SODIUM HYDROXIDE Unresolved BC-Boiler compound , B&N-Buffer & neutralizing agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
7. Sorbitan SORBITAN Molecular
8. Sorbitol SORBITOL Molecular MISC-Miscellaneous GRAS-Generally recognized as safe.

Active Ingredients ( 1 Total)

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

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