Application Nr Approved Date Route Status External Links
ANDA078558 2007-06-18 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Carefully Consider The Potential Benefits And Risks Of Ibuprofen Tablets, Usp And Other Treatment Options Before Deciding To Use Ibuprofen Tablets, Usp. Use The Lowest Effective Dose For The Shortest Duration Consistent With Individual Patient Treatment Goals (see Warnings). Ibuprofen Tablets, Usp Are Indicated For Relief Of The Signs And Symptoms Of Rheumatoid Arthritis And Osteoarthritis. Ibuprofen Tablets, Usp Are Indicated For Relief Of Mild To Moderate Pain. Ibuprofen Tablets, Usp Are Also Indicated For The Treatment Of Primary Dysmenorrhea. Controlled Clinical Trials To Establish The Safety And Effectiveness Of Ibuprofen Tablets, Usp In Children Have Not Been Conducted.

All Formulated Excipients (8 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. Croscarmellose Sodium CROSCARMELLOSE SODIUM Unresolved
3. 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.
4. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
5. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
6. Polyvinyl Alcohol POLYVINYL ALCOHOL Unresolved
7. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.
8. Stearic Acid STEARIC 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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