Nighttime Sleep Aid

FDA Drug Profile — Nighttime Sleep Aid

Nighttime Sleep Aid is listed in the FDA National Drug Code directory with 4 NDC codes, marketed under brand name including Nighttime Sleep Aid. Available dosage forms: liquid, tablet.

Drug Details

Generic Name
Nighttime Sleep Aid
Brand Names
Nighttime Sleep Aid
Application Number
M010
Sponsor
Allegiant Health
NDC Codes
4
Dosage Forms
LIQUID, TABLET
Routes
ORAL
Active Ingredients
DIPHENHYDRAMINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE

Indications and Usage

Use(s) reduces time to fall asleep if you have difficulty falling asleep for relief of occasional sleeplessness

Warnings

Warnings Do not use Do not use n for children under 12 years of age. with any other product containing diphenhydramine, even one used on skin with any other drugs that cause drowsiness such as antihistamines and nighttime cough, cold/flu products Ask a doctor before use if heart disease trouble urinating due to an enlarged prostate gland glaucoma a breathing problem such as asthma, emphysema or chronic bronchitis Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers or any other sleep aid When using this product do not use more than directed avoid alcoholic beverages and other drugs that cause drowsiness drowsiness will occur be careful when driving a motor vehicle or operating machinery alcohol, sedatives, and tranquilizers may increase drowsiness Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness. If pregnant or breastfeeding, ask a health professional before use. Keep out of reach of children In case of overdose, get medical help or contact a Poison Control Center right away.