doxylamine succinate and pyridoxine hydrochloride tablet delayed release

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.

FDA Reported Adverse Reactions
`[1] toxicity to various agents` `[2] nausea` `[3] off label use` `[4] drug ineffective` `[5] fatigue` `[6] completed suicide` `[7] dyspnoea` `[8] pain` `[9] drug abuse` `[10] death`

4 years ago

ROUND WHITE M DP

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 20° to 25°C (68° to 77°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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doxylamine succinate and pyridoxine hydrochloride tablet delayed release

FDA Reported Adverse Reactions [1] toxicity to various agents [2] nausea [3] off label use [4] drug ineffective [5] fatigue [6] completed suicide [7] dyspnoea [8] pain [9] drug abuse [10] death

ROUND WHITE M DP

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FDA Reported Adverse Reactions
`[1] toxicity to various agents` `[2] nausea` `[3] off label use` `[4] drug ineffective` `[5] fatigue` `[6] completed suicide` `[7] dyspnoea` `[8] pain` `[9] drug abuse` `[10] death`