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 tablets have 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 )
mylan pharmaceuticals inc.
16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied
DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE Delayed-Release Tablets are available containing 10 mg of doxylamine succinate, USP and 10 mg of pyridoxine hydrochloride, USP. The 10 mg/10 mg tablets are white to off-white, film-coated, round, unscored tablets imprinted with M over DP in black ink on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-4615-01 bottles of 100 tablets 16.2 Storage and Handling Store at 20Â° to 25Â°C (68Â° to 77Â°F). [See USP Controlled Room Temperature.] Keep bottle tightly closed. Protect from moisture and light. Do not remove desiccant from bottle. Dispense in original container or equivalent air tight, light resistant container.
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