Diphenhydramine HCl 50mg

FDA Drug Profile — Nighttime SLEEP AID, PHARBEDRYL

Drug Details

Generic Name
Diphenhydramine HCl 50mg
Brand Names
Nighttime SLEEP AID, PHARBEDRYL
Application Number
M010
Sponsor
PuraCap Pharmaceutical LLC
NDC Codes
2
Dosage Forms
CAPSULE, LIQUID FILLED, CAPSULE
Routes
ORAL
Active Ingredients
DIPHENHYDRAMINE HYDROCHLORIDE

Indications and Usage

Use(s) for relief of occasional sleeplessness

Warnings

Warnings Do not use if you have for children under 12 years of age with any other products containing diphenhydramine, even one used on skin Ask a doctor before use if you a breathing problem such as emphysema or chronic bronchitis glaucoma trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers When using this product avoid alcoholic drinks 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.