Application Nr Approved Date Route Status External Links
ANDA074567 2001-04-17 Oral OTC Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Active Ingredients (in Each Caplet) Purposes Ibuprofen, Usp 200 Mg (nsaid)nonsteroidal Anti-Inflammatory Drug Pain Reliever/fever Reducer Pseudoephedrine Hcl, Usp 30 Mg Nasal Decongestant

All Formulated Excipients (20 Total)

Name Structure Kind Function Status
1. Acacia ACACIA Unresolved EMUL-Emulsifier , STAB-Stabilizer FS-Substances permitted as optional ingredient in a standardized food.
2. Calcium Carbonate CALCIUM CARBONATE Molecular DS-Dietary supplement , DYE-Dye , EMUL-Emulsifier , MISC-Miscellaneous , NUTR-Nutrient GRAS-Generally recognized as safe.
3. Carnauba Wax CARNAUBA WAX Unresolved MISC-Miscellaneous GRAS-Generally recognized as safe.
4. Sucrose SUCROSE Molecular NUTRS-Nutritive Sweetener GRAS-Generally recognized as safe.
5. Starch, Corn STARCH, CORN Unresolved
6. Croscarmellose Sodium CROSCARMELLOSE SODIUM Unresolved
7. Gelatin GELATIN Unresolved
8. Guar Gum GUAR GUM Unresolved STAB-Stabilizer FS-Substances permitted as optional ingredient in a standardized food.
9. Ferrosoferric Oxide FERROSOFERRIC OXIDE Molecular
10. Kaolin KAOLIN Molecular
11. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
12. Powdered Cellulose POWDERED CELLULOSE Unresolved
13. Povidones POVIDONES Unresolved
14. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
15. Shellac SHELLAC Unresolved
16. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
17. Sodium Benzoate SODIUM BENZOATE Molecular
18. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.
19. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye
20. White Wax WHITE WAX Unresolved

Active Ingredients ( 2 Total)

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