Application Nr Approved Date Route Status External Links
ANDA078682 2009-03-24 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 (7 Total)

Name Structure Kind Function Status
1. Gelatin GELATIN Unresolved
2. Mannitol MANNITOL Molecular NUTR-Nutrient GRAS-Generally recognized as safe.
3. Polyethylene Glycol 600 POLYETHYLENE GLYCOL 600 Unresolved
4. Potassium Hydroxide POTASSIUM HYDROXIDE Unresolved B&N-Buffer & neutralizing agent , MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
5. Water WATER Molecular
6. Sorbitan SORBITAN Molecular
7. Sorbitol SORBITOL Molecular MISC-Miscellaneous GRAS-Generally recognized as safe.

Active Ingredients ( 1 Total)

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

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