Application Nr Approved Date Route Status External Links
NDA022565 2010-05-27 Oral OTC Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Active Ingredients (in Each Tablet) Purposes Ibuprofen 200 Mg (nsaid)nonsteroidal Anti-Inflammatory Drug Pain Reliever/fever Reducer Phenylephrine Hcl 10 Mg Nasal Decongestant

All Formulated Excipients (23 Total)

Name Structure Kind Function Status
1. Acesulfame Potassium ACESULFAME POTASSIUM Molecular NNS-Non-nutritive sweetener REG-Food additives for which a petition has been filed and a regulation issued.
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. Glycerin GLYCERIN Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
7. Hypromelloses HYPROMELLOSES Unresolved
8. Lactic Acid, Unspecified Form LACTIC ACID, UNSPECIFIED FORM Molecular
9. Lecithin LECITHIN Unresolved
10. Maltodextrin MALTODEXTRIN Unresolved GRAS-Generally recognized as safe.
11. Medium-Chain Triglycerides MEDIUM-CHAIN TRIGLYCERIDES Unresolved
12. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
13. Polydextrose POLYDEXTROSE Unresolved MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
14. Polyvinyl Alcohol POLYVINYL ALCOHOL Unresolved
15. Propyl Gallate PROPYL GALLATE Molecular AOX-Antioxidant REG-Food additives for which a petition has been filed and a regulation issued.
16. 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.
17. Stearic Acid STEARIC ACID Molecular MISC-Miscellaneous GRAS-Generally recognized as safe.
18. Sucralose SUCRALOSE Molecular NNS-Non-nutritive sweetener REG-Food additives for which a petition has been filed and a regulation issued.
19. Synthetic Iron Oxides SYNTHETIC IRON OXIDES Unresolved
20. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.
21. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye
22. Triacetin TRIACETIN Molecular MISC-Miscellaneous GRAS-Generally recognized as safe.
23. Xanthan Gum XANTHAN GUM Unresolved EMUL-Emulsifier FS-Substances permitted as optional ingredient in a standardized food.

Active Ingredients ( 2 Total)

Comments