Ibu

Product manufactured by Unit Dose Services

Application Nr Approved Date Route Status External Links
ANDA075682 2001-11-14 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 Ibuprofentablets And Other Treatment Options Before Deciding To Use Ibuprofen.use The Lowest Effective Dose For The Shortest Duration Consistent Withindividual Patient Treatment Goals (see Warnings ). Ibu Tablets Are Indicated For Relief Of The Signs And Symptoms Of Rheumatoid Arthritis And Osteoarthritis. Ibu Tablets Are Indicated For Relief Of Mild To Moderate Pain. Ibu Tablets Are Also Indicated For The Treatment Of Primary Dysmenorrhea. Controlled Clinical Trials To Establish The Safety And Effectiveness Of Ibu Tablets In Children Have Not Been Conducted.

All Formulated Excipients (8 Total)

Name Structure Kind Function Status
1. Carnauba Wax CARNAUBA WAX Unresolved MISC-Miscellaneous GRAS-Generally recognized as safe.
2. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
3. Croscarmellose Sodium CROSCARMELLOSE SODIUM Unresolved
4. Hypromelloses HYPROMELLOSES Unresolved
5. 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.
6. Polydextrose POLYDEXTROSE Unresolved MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
7. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
8. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye

Active Ingredients ( 1 Total)

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

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