Application Nr Approved Date Route Status External Links
NDA022113 2017-04-28 Oral OTC Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Active Ingredients (in Each Tablet) Purposes Chlorpheniramine Maleate 4 Mg Antihistamine Ibuprofen 200 Mg (nsaid)nonsteroidal Anti-Inflammatory Drug Pain Reliever/fever Reducer Phenylephrine Hcl 10 Mg Nasal Decongestant

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

Active Ingredients ( 3 Total)

Comments