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Are Unisom SleepTabs, SleepGels and SleepMelts safe and effective?

April 26, 2017effective safe sleepgels sleepmelts sleeptabs unisom

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Are Unisom SleepTabs, SleepGels and SleepMelts safe and effective?

1 Answer

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Both formulas are considered GRAS/E (generally recognized as safe and effective) by FDA. SleepGels’ and SleepMelts’ active ingredient 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). SleepTabs contain doxylamine succinate (25 mg/dose) and is FDA approved under an NDA (New Drug Application).