doxylamine succinate and pyridoxine hydrochloride
Drug Details
- Generic Name
- doxylamine succinate and pyridoxine hydrochloride
- Brand Names
- Doxylamine Succinate and Pyridoxine Hydrochloride, BONJESTA, DICLEGIS
- Application Number
- ANDA207825
- Sponsor
- Mylan Pharmaceuticals Inc.
- NDC Codes
- 3
- Dosage Forms
- TABLET, DELAYED RELEASE, TABLET, EXTENDED RELEASE
- Routes
- ORAL
- Active Ingredients
- DOXYLAMINE SUCCINATE, PYRIDOXINE HYDROCHLORIDE
Indications and Usage
1 INDICATIONS AND USAGE BONJESTA is indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. Limitations of Use BONJESTA has not been studied in women with hyperemesis gravidarum. BONJESTA is a fixed dose combination drug product of 20 mg doxylamine succinate, an antihistamine, and 20 mg pyridoxine hydrochloride, a Vitamin B 6 analog, indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. ( 1 )