Diphenhydramine HCl Tablets

FDA Drug Profile — Sleep Tabs For Nighttime use

Drug Details

Generic Name
Diphenhydramine HCl Tablets
Brand Names
Sleep Tabs For Nighttime use
Application Number
M012
Sponsor
Allegiant Health
NDC Codes
1
Dosage Forms
TABLET
Routes
ORAL
Active Ingredients
DIPHENHYDRAMINE HYDROCHLORIDE

Indications and Usage

Uses relief of occasional sleeplessness

Warnings

Warnings Do not use with any other products containing diphenhydramine, including one used on skin in children under 12 years of age Ask a doctor before use if you have 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 marked drowsiness may occur avoid alcoholic beverages do not drive a motor vehicle or operate machinery 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 If pregnant or breast-feeding, ask a health professional before use.