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Are Unisom SleepTabs, SleepGels, SleepMelts and PM Pain SleepCaps safe and effective?

April 26, 2017effective pain PM safe sleepgels sleepmelts sleeptabs unisom

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Are Unisom SleepTabs, SleepGels, SleepMelts and PM Pain SleepCaps safe and effective?

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All Unisom formulas are considered GRAS/E (generally recognized as safe and effective) by FDA. The active sleep-aid ingredient in SleepGels, SleepMelts and PM Pain SleepCaps (diphenhydramine HCl, 50 mg/dose) is permitted for use as a nighttime sleep-aid by US FDA under the nighttime sleep-aid OTC drug monograph (21 CFR Part 338). PM Pain SleepCaps also contains the pain reliever acetaminophen permitted for use as an analgesic (21 CFS Part 343). SleepTabs contain doxylamine succinate (25 mg/dose) and is FDA approved under an NDA (New Drug Application).