Application Nr Approved Date Route Status External Links
NDA018989 1984-05-18 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 (22 Total)

Name Structure Kind Function Status
1. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
2. Starch, Corn STARCH, CORN Unresolved
3. Croscarmellose Sodium CROSCARMELLOSE SODIUM Unresolved
4. Methylparaben METHYLPARABEN Molecular PRES-Chemical preservative REG-Food additives for which a petition has been filed and a regulation issued.
5. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
6. Shellac SHELLAC Unresolved
7. Povidones POVIDONES Unresolved
8. Propylparaben PROPYLPARABEN Molecular PRES-Chemical preservative REG-Food additives for which a petition has been filed and a regulation issued.
9. Sodium Benzoate SODIUM BENZOATE Molecular
10. Sodium Lauryl Sulfate SODIUM LAURYL SULFATE Molecular AF-Antifoaming (or defoaming) agent , CTG-Component or coating , EMUL-Emulsifier , SANI-Sanitizing agent , SDA-Solubilizing & dispersing agent REG-Food additives for which a petition has been filed and a regulation issued.
11. Stearic Acid STEARIC ACID Molecular MISC-Miscellaneous GRAS-Generally recognized as safe.
12. Sucrose SUCROSE Molecular NUTRS-Nutritive Sweetener GRAS-Generally recognized as safe.
13. Synthetic Iron Oxides SYNTHETIC IRON OXIDES Unresolved
14. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye
15. Fd&c Red No. 40 FD&C RED NO. 40 Molecular
16. Fd&c Yellow No. 6 FD&C YELLOW NO. 6 Molecular DYE-Dye
17. Medium-Chain Triglycerides MEDIUM-CHAIN TRIGLYCERIDES Unresolved
18. Gelatin GELATIN Unresolved
19. Glycerin GLYCERIN Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
20. Hypromelloses HYPROMELLOSES Unresolved
21. Propyl Gallate PROPYL GALLATE Molecular AOX-Antioxidant REG-Food additives for which a petition has been filed and a regulation issued.
22. Water WATER Molecular

Active Ingredients ( 1 Total)

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

Comments