Application Nr Approved Date Route Status External Links
ANDA075706 2003-02-21 Oral OTC Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Purpose Antihistamine Nasal Decongestant

All Formulated Excipients (12 Total)

Name Structure Kind Function Status
1. Ferrosoferric Oxide FERROSOFERRIC OXIDE Molecular
2. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
3. Glyceryl Monostearate GLYCERYL MONOSTEARATE Molecular
4. Hypromelloses HYPROMELLOSES Unresolved
5. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
6. 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.
7. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
8. Polysorbate 80 POLYSORBATE 80 Unresolved AF-Antifoaming (or defoaming) agent , EMUL-Emulsifier , MISC-Miscellaneous , SDA-Solubilizing & dispersing agent REG-Food additives for which a petition has been filed and a regulation issued.
9. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
10. Sodium Lauryl Sulfate SODIUM LAURYL SULFATE Molecular AF-Antifoaming (or defoaming) agent , CTG-Component or coating , EMUL-Emulsifier , SANI-Sanitizing agent , SDA-Solubilizing & dispersing agent REG-Food additives for which a petition has been filed and a regulation issued.
11. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.
12. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye

Active Ingredients ( 2 Total)

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