Application Nr Approved Date Route Status External Links
ANDA076460 2003-11-26 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. Carnauba Wax CARNAUBA WAX Unresolved MISC-Miscellaneous GRAS-Generally recognized as safe.
2. Croscarmellose Sodium CROSCARMELLOSE SODIUM Unresolved
3. Hypromelloses HYPROMELLOSES Unresolved
4. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
5. Polydextrose POLYDEXTROSE Unresolved MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
6. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
7. Ferric Oxide Red FERRIC OXIDE RED Molecular
8. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
9. Stearic Acid STEARIC ACID Molecular MISC-Miscellaneous GRAS-Generally recognized as safe.
10. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye

Active Ingredients ( 1 Total)

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

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