doxylamine succinate and pyridoxine hydrochloride
Drug Details
- Generic Name
- doxylamine succinate and pyridoxine hydrochloride
- Brand Names
- BONJESTA, Doxylamine Succinate and Pyridoxine Hydrochloride, DICLEGIS
- Application Number
- NDA209661
- Sponsor
- Duchesnay USA, Inc.
- NDC Codes
- 3
- Dosage Forms
- TABLET, EXTENDED RELEASE, TABLET, DELAYED RELEASE
- Routes
- ORAL
- Active Ingredients
- DOXYLAMINE SUCCINATE, PYRIDOXINE HYDROCHLORIDE
Indications and Usage
1 INDICATIONS AND USAGE Doxylamine succinate and pyridoxine hydrochloride delayed-release tablets are indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. Limitations of Use Doxylamine succinate and pyridoxine hydrochloride delayed-release tablet has not been studied in women with hyperemesis gravidarum. Doxylamine succinate and pyridoxine hydrochloride delayed-release tablets are 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)