Application Nr Approved Date Route Status External Links
ANDA078569 2011-12-14 Oral OTC Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Purpose Pain Reliever/fever Reducer

All Formulated Excipients (14 Total)

Name Structure Kind Function Status
1. Croscarmellose Sodium CROSCARMELLOSE SODIUM Unresolved
2. Gelatin GELATIN Unresolved
3. Glycerin GLYCERIN Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
4. Hypromelloses HYPROMELLOSES Unresolved
5. Ferrosoferric Oxide FERROSOFERRIC OXIDE Molecular
6. Ferric Oxide Yellow FERRIC OXIDE YELLOW Molecular
7. Magnesium Stearate MAGNESIUM STEARATE Molecular AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
8. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
9. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
10. Povidones POVIDONES Unresolved
11. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
12. 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.
13. Starch STARCH Unresolved SANI-Sanitizing agent REG-Food additives for which a petition has been filed and a regulation issued.
14. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Acetaminophen ACETAMINOPHEN ZINC13550868

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