Application Nr Approved Date Route Status External Links
ANDA075794 2001-11-26 Oral OTC Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Purposes Pain Reliever Pain Reliever Aid

All Formulated Excipients (8 Total)

Name Structure Kind Function Status
1. Carnauba Wax CARNAUBA WAX Unresolved MISC-Miscellaneous GRAS-Generally recognized as safe.
2. Hypromelloses HYPROMELLOSES Unresolved
3. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
4. Povidones POVIDONES Unresolved
5. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
6. Saccharin Sodium SACCHARIN SODIUM Molecular
7. Stearic Acid STEARIC ACID Molecular MISC-Miscellaneous GRAS-Generally recognized as safe.
8. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye

Active Ingredients ( 3 Total)

Name Structure ZINC ID(s)
1. Acetaminophen ACETAMINOPHEN ZINC13550868
2. Aspirin ASPIRIN ZINC53
3. Caffeine CAFFEINE ZINC1084

Comments