Application Nr Approved Date Route Status External Links
ANDA079113 2008-12-22 Oral OTC Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Purposes Nighttime Sleep-Aid Pain Reliever

All Formulated Excipients (10 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. Glyceryl Dibehenate GLYCERYL DIBEHENATE Unresolved
4. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
5. 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.
6. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
7. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
8. Polyvinyl Alcohol POLYVINYL ALCOHOL Unresolved
9. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.
10. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye

Active Ingredients ( 2 Total)

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