Nighttime Sleep Aid

FDA Drug Profile — Nighttime Sleep Aid

Drug Details

Generic Name
Nighttime Sleep Aid
Brand Names
Nighttime Sleep Aid
Application Number
ANDA040564
Sponsor
Allegiant Health
NDC Codes
4
Dosage Forms
TABLET, LIQUID
Routes
ORAL
Active Ingredients
DOXYLAMINE SUCCINATE, DIPHENHYDRAMINE HYDROCHLORIDE

Indications and Usage

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

Warnings

Warnings Do not use for children under 12 years of age with any other product containing diphenhydramine, even one used on skin with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu product Ask a doctor before use if you have • a breathing problem such as emphysema or chronic bronchitis • glaucoma • difficulty in urination due to enlargement of the prostate gland Ask a doctor or pharmacist before use if if you are taking sedatives or tranquilizers When using this product avoid alcoholic beverages. Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a 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 (1-800-222-1222) right away.