Application Nr Approved Date Route Status External Links
ANDA076359 2004-01-16 Oral OTC Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Purposes Pain Reliever/fever Reducer

All Formulated Excipients (12 Total)

Name Structure Kind Function Status
1. Acesulfame Potassium ACESULFAME POTASSIUM Molecular NNS-Non-nutritive sweetener REG-Food additives for which a petition has been filed and a regulation issued.
2. Aspartame ASPARTAME Molecular NUTRS-Nutritive Sweetener REG-Food additives for which a petition has been filed and a regulation issued.
3. Carnauba Wax CARNAUBA WAX Unresolved MISC-Miscellaneous GRAS-Generally recognized as safe.
4. Croscarmellose Sodium CROSCARMELLOSE SODIUM Unresolved
5. Hypromelloses HYPROMELLOSES Unresolved
6. 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.
7. Mannitol MANNITOL Molecular NUTR-Nutrient GRAS-Generally recognized as safe.
8. Prosweet PROSWEET Unresolved
9. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
10. 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.
11. Soybean Oil SOYBEAN OIL Unresolved
12. Succinic Acid SUCCINIC ACID Molecular MISC-Miscellaneous GRAS-Generally recognized as safe.

Active Ingredients ( 1 Total)

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

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