Application Nr Approved Date Route Status External Links
NDA022032 2007-12-04 Oral OTC Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Purpose Acid Reducer

All Formulated Excipients (16 Total)

Name Structure Kind Function Status
1. Benzyl Alcohol BENZYL ALCOHOL Molecular
2. Carmine CARMINE Molecular DYE-Dye
3. Carnauba Wax CARNAUBA WAX Unresolved MISC-Miscellaneous GRAS-Generally recognized as safe.
4. Hypromelloses HYPROMELLOSES Unresolved
5. Hypromellose Acetate Succinate HYPROMELLOSE ACETATE SUCCINATE Unresolved
6. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
7. Monoethanolamine MONOETHANOLAMINE Molecular MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
8. Polyethylene Glycol 3350 POLYETHYLENE GLYCOL 3350 Unresolved
9. 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.
10. Sodium Stearate SODIUM STEARATE Molecular MISC-Miscellaneous , STAB-Stabilizer PS-Substances for which prior sanction has been granted by FDA for specific uses.
11. Sodium Stearyl Fumarate SODIUM STEARYL FUMARATE Molecular MISC-Miscellaneous , STAB-Stabilizer REG-Food additives for which a petition has been filed and a regulation issued.
12. Sucralose SUCRALOSE Molecular NNS-Non-nutritive sweetener REG-Food additives for which a petition has been filed and a regulation issued.
13. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.
14. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye
15. Triacetin TRIACETIN Molecular MISC-Miscellaneous GRAS-Generally recognized as safe.
16. Triethyl Citrate TRIETHYL CITRATE Molecular MISC-Miscellaneous GRAS-Generally recognized as safe.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Omeprazole OMEPRAZOLE ZINC4693575

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