Diphenhyramine Hydrochloride

FDA Drug Profile — EZ Nite Sleep, Nighttime Sleep Aid

Drug Details

Generic Name
Diphenhyramine Hydrochloride
Brand Names
EZ Nite Sleep, Nighttime Sleep Aid
Application Number
M010
Sponsor
KROGER COMPANY
NDC Codes
2
Dosage Forms
CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients
DIPHENHYDRAMINE HYDROCHLORIDE

Indications and Usage

Uses ■ 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. Do not use ■ for children under 12 years of age ■ with any other product containing diphenhydramine, even one used on skin. 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 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 serious underlying medical illness. If pregnant or breast-feeding, 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.