doxylamine succinate 10 MG Pyridoxine Hydrochloride 10 MG Delayed Release Oral Tablet

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 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 )

actavis pharma, inc.

FDA Reported Adverse Reactions
`[1] adverse drug reaction` `[2] drug ineffective` `[3] application site pruritus` `[4] off label use` `[5] application site irritation` `[6] headache` `[7] application site pain` `[8] alopecia` `[9] condition aggravated` `[10] rash`

5 years ago

ROUND WHITE 2132

5 years ago

2132 ROUND WHITE

16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How supplied

DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE delayed-release tablets 100 bottle count is supplied in a high-density polyethylene bottle with a polypropylene child-resistant cap and a silica gel desiccant canister. Each white to off white, unscored, round, biconvex film-coated, delayed-release tablet contains 10 mg doxylamine succinate, USP and 10 mg pyridoxine hydrochloride, USP and is printed with “ 2132 ” on one side with black ink and plain on the other.

DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE delayed-release tablets are provided as follows: NDC 0591-2132-01 Bottles of 100. 16.2 Storage and Handling Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Keep bottle tightly closed and protect from moisture. Do not remove desiccant canister from bottle.

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doxylamine succinate 10 MG Pyridoxine Hydrochloride 10 MG Delayed Release Oral Tablet

FDA Reported Adverse Reactions [1] adverse drug reaction [2] drug ineffective [3] application site pruritus [4] off label use [5] application site irritation [6] headache [7] application site pain [8] alopecia [9] condition aggravated [10] rash

ROUND WHITE 2132

2132 ROUND WHITE

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FDA Reported Adverse Reactions
`[1] adverse drug reaction` `[2] drug ineffective` `[3] application site pruritus` `[4] off label use` `[5] application site irritation` `[6] headache` `[7] application site pain` `[8] alopecia` `[9] condition aggravated` `[10] rash`