Diclegis

Product manufactured by Duchesnay Usa, Inc.

Application Nr Approved Date Route Status External Links
NDA021876 2013-04-08 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Diclegis Is Indicated For The Treatment Of Nausea And Vomiting Of Pregnancy In Women Who Do Not Respond To Conservative Management. Limitations Of Use Diclegis Has Not Been Studied In Women With Hyperemesis Gravidarum. Diclegis Is A Fixed Dose Combination Drug Product Of Doxylamine Succinate, An Antihistamine, And Pyridoxine Hydrochloride, A Vitamin B6 Analog, Indicated For The Treatment Of Nausea And Vomiting Of Pregnancy In Women Who Do Not Respond To Conservative Management. (1)

All Formulated Excipients (19 Total)

Name Structure Kind Function Status
1. Butyl Alcohol BUTYL ALCOHOL Molecular MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
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. Isopropyl Alcohol ISOPROPYL ALCOHOL Molecular
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. Magnesium Trisilicate MAGNESIUM TRISILICATE Molecular
8. Methacrylic Acid Copolymer METHACRYLIC ACID COPOLYMER Unresolved
9. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
10. Polyethylene Glycol 400 POLYETHYLENE GLYCOL 400 Unresolved
11. Polyethylene Glycol 8000 POLYETHYLENE GLYCOL 8000 Unresolved
12. Polysorbate 80 POLYSORBATE 80 Unresolved AF-Antifoaming (or defoaming) agent , EMUL-Emulsifier , MISC-Miscellaneous , SDA-Solubilizing & dispersing agent REG-Food additives for which a petition has been filed and a regulation issued.
13. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
14. Simethicone SIMETHICONE Unresolved
15. Sodium Bicarbonate SODIUM BICARBONATE Molecular MISC-Miscellaneous , SANI-Sanitizing agent REG-Food additives for which a petition has been filed and a regulation issued.
16. 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.
17. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.
18. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye
19. Triethyl Citrate TRIETHYL CITRATE Molecular MISC-Miscellaneous GRAS-Generally recognized as safe.

Active Ingredients ( 2 Total)

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