Application Nr Approved Date Route Status External Links
ANDA079043 2011-06-22 Oral OTC Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Purpose Antihistamine Nasal Decongestant

All Formulated Excipients (9 Total)

Name Structure Kind Function Status
1. Acetyltributyl Citrate ACETYLTRIBUTYL CITRATE Molecular
2. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
3. Copovidone K25-31 COPOVIDONE K25-31 Unresolved
4. Croscarmellose Sodium CROSCARMELLOSE SODIUM Unresolved
5. Ethylcelluloses ETHYLCELLULOSES Unresolved
6. Hypromelloses HYPROMELLOSES Unresolved
7. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
8. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
9. Sodium Stearyl Fumarate SODIUM STEARYL FUMARATE Molecular MISC-Miscellaneous , STAB-Stabilizer REG-Food additives for which a petition has been filed and a regulation issued.

Active Ingredients ( 2 Total)

Comments