Application Nr Approved Date Route Status External Links
ANDA079205 2009-06-26 Oral OTC Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Purpose Pain Reliever /fever Reducer

All Formulated Excipients (10 Total)

Name Structure Kind Function Status
1. Ammonia AMMONIA Molecular
2. Fd&c Green No. 3 FD&C GREEN NO. 3 Molecular DYE-Dye
3. Gelatin GELATIN Unresolved
4. Ferrosoferric Oxide FERROSOFERRIC OXIDE Molecular
5. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
6. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
7. Potassium Hydroxide POTASSIUM HYDROXIDE Molecular B&N-Buffer & neutralizing agent , MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
8. Water WATER Molecular
9. Shellac SHELLAC Unresolved
10. Sorbitan Monooleate SORBITAN MONOOLEATE Molecular EMUL-Emulsifier REG-Food additives for which a petition has been filed and a regulation issued.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Ibuprofen IBUPROFEN ZINC2647

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