Application Nr Approved Date Route Status External Links
ANDA076447 2011-04-13 Oral OTC Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Purpose Antihistamine

All Formulated Excipients (12 Total)

Name Structure Kind Function Status
1. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
2. Croscarmellose Sodium CROSCARMELLOSE SODIUM Unresolved
3. Hypromelloses HYPROMELLOSES Unresolved
4. Ferrosoferric Oxide FERROSOFERRIC OXIDE Unresolved
5. Ferric Oxide Red FERRIC OXIDE RED Unresolved
6. Ferric Oxide Yellow FERRIC OXIDE YELLOW Unresolved
7. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
8. Magnesium Stearate MAGNESIUM STEARATE Molecular AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
9. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
10. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
11. Povidones POVIDONES Unresolved
12. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Fexofenadine Hydrochloride FEXOFENADINE HYDROCHLORIDE ZINC3824921

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