Application Nr Approved Date Route Status External Links
ANDA206581 2015-08-03 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 (9 Total)

Name Structure Kind Function Status
1. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
2. Glyceryl Monostearate GLYCERYL MONOSTEARATE Molecular
3. Ferric Oxide Yellow FERRIC OXIDE YELLOW Molecular
4. Mannitol MANNITOL Molecular NUTR-Nutrient GRAS-Generally recognized as safe.
5. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
6. Polyvinyl Alcohol POLYVINYL ALCOHOL Unresolved
7. 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.
8. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.
9. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Ibuprofen Sodium IBUPROFEN SODIUM ZINC2647

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