Application Nr Approved Date Route Status External Links
NDA020267 1996-12-13 Oral OTC Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Purpose Fever Reducer/pain Reliever

All Formulated Excipients (15 Total)

Name Structure Kind Function Status
1. Diacetylated Monoglycerides DIACETYLATED MONOGLYCERIDES Unresolved
2. Carnauba Wax CARNAUBA WAX Unresolved MISC-Miscellaneous GRAS-Generally recognized as safe.
3. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
4. Starch, Corn STARCH, CORN Unresolved
5. Croscarmellose Sodium CROSCARMELLOSE SODIUM Unresolved
6. Methylparaben METHYLPARABEN Molecular PRES-Chemical preservative REG-Food additives for which a petition has been filed and a regulation issued.
7. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
8. Shellac SHELLAC Unresolved
9. Povidones POVIDONES Unresolved
10. Propylparaben PROPYLPARABEN Molecular PRES-Chemical preservative REG-Food additives for which a petition has been filed and a regulation issued.
11. Sodium Benzoate SODIUM BENZOATE Molecular
12. Stearic Acid STEARIC ACID Molecular MISC-Miscellaneous GRAS-Generally recognized as safe.
13. Sucrose SUCROSE Molecular NUTRS-Nutritive Sweetener GRAS-Generally recognized as safe.
14. Synthetic Iron Oxides SYNTHETIC IRON OXIDES Unresolved
15. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye

Active Ingredients ( 1 Total)

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

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