doxepin hydrochloride 3 mg

1 INDICATIONS AND USAGE Doxepin Tablets are indicated for the treatment of insomnia characterized by difficulty with sleep maintenance. The clinical trials performed in support of efficacy were up to 3 months in duration. Doxepin tablets are indicated for the treatment of insomnia characterized by difficulties with sleep maintenance. (1, 14)

strides pharma science limited

FDA Reported Adverse Reactions
`[1] drug ineffective` `[2] pruritus` `[3] rash` `[4] off label use` `[5] product use in unapproved indication` `[6] arthralgia` `[7] fatigue` `[8] pain` `[9] condition aggravated` `[10] headache`

6 months ago

OVAL WHITE P 012

6 months ago

P 012 OVAL WHITE

16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Doxepin Tablets 3 mg are white to off white, oval shaped tablets, with "P" on one side and "012" on the other side, and are supplied as: NDC 64380-203-01 Bottle of 30 NDC 64380-203-02 Bottle of 100 NDC 64380-203-03 Bottle of 500 Doxepin Tablets 6 mg are white to off white, round shaped biconvex tablets, with "P" on one side and "013" on the other side, and are supplied as: NDC 64380-204-01 Bottle of 30 NDC 64380-204-02 Bottle of 100 NDC 64380-204-03 Bottle of 500 16.2 Storage and Handling Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light.

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