Application Nr Approved Date Route Status External Links
NDA021374 2002-05-30 Oral OTC Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Purposes Pain Reliever/fever Reducer Nasal Decongestant

All Formulated Excipients (7 Total)

Name Structure Kind Function Status
1. D&c Yellow No. 10 D&C YELLOW NO. 10 Molecular DYE-Dye
2. Fd&c Red No. 40 FD&C RED NO. 40 Molecular
3. Gelatin GELATIN Unresolved
4. Medium-Chain Triglycerides MEDIUM-CHAIN TRIGLYCERIDES Unresolved
5. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
6. Potassium Hydroxide POTASSIUM HYDROXIDE Molecular B&N-Buffer & neutralizing agent , MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
7. Water WATER Molecular

Active Ingredients ( 2 Total)

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