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 (9 Total)

Name Structure Kind Function Status
1. Ammonia AMMONIA Molecular
2. Gelatin GELATIN Unresolved
3. Ferrosoferric Oxide FERROSOFERRIC OXIDE Molecular
4. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
5. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
6. Potassium Hydroxide POTASSIUM HYDROXIDE Molecular B&N-Buffer & neutralizing agent , MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
7. Water WATER Molecular
8. Shellac SHELLAC Unresolved
9. 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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