Application Nr Approved Date Route Status External Links
ANDA090397 2010-11-22 Oral OTC Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Purpose Nighttime Sleep-Aid Pain Reliever

All Formulated Excipients (6 Total)

Name Structure Kind Function Status
1. Gelatin GELATIN Unresolved
2. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
3. Potassium Hydroxide POTASSIUM HYDROXIDE Molecular B&N-Buffer & neutralizing agent , MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
4. Water WATER Molecular
5. Sorbitan SORBITAN Molecular
6. Sorbitol SORBITOL Molecular MISC-Miscellaneous GRAS-Generally recognized as safe.

Active Ingredients ( 2 Total)

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