Sleep Aid

FDA Drug Profile — Sleep Aid, Diphenhydramine HCl 25mg

Drug Details

Generic Name
Sleep Aid
Brand Names
Sleep Aid, Diphenhydramine HCl 25mg
Application Number
M010
Sponsor
Better Living Brands LLC
NDC Codes
4
Dosage Forms
CAPSULE, LIQUID FILLED, TABLET, COATED
Routes
ORAL
Active Ingredients
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.