diphenhydramine hydrochloride

FDA Drug Profile — Diphenhydramine Hydrochloride, diphenhydramine hydrochloride, Itch Relief, Harris Teeter Allergy Relief, Diphenhydramine HCl

diphenhydramine hydrochloride is listed in the FDA National Drug Code directory with 36 NDC codes, marketed under brand names including Diphenhydramine Hydrochloride, diphenhydramine hydrochloride, Itch Relief. Available dosage forms: injection, tablet, film coated, liquid, capsule, liquid filled, solution.

Drug Details

Generic Name
diphenhydramine hydrochloride
Brand Names
Diphenhydramine Hydrochloride, diphenhydramine hydrochloride, Itch Relief, Harris Teeter Allergy Relief, Diphenhydramine HCl, Up and Up Nighttime Sleep Aid, childrens allergy, Simply Sleep, Diphenhydramine HCl Oral Solution, Diphenhydramine hydrochloride, Diphenhydramine, Benadryl Allergy Liqui-Gels, Discount Drugmart Allergy Relief, Sleep Aid, equate nighttime sleep aid, TopCare Allergy Relief, Kroger Allergy Relief, Good Neighbor Allergy Relief, Childrens Benadryl Chewables, Benadryl, Quality Choice Allergy Relief
Application Number
ANDA080817
Sponsor
Sportpharm LLC
NDC Codes
36
Dosage Forms
INJECTION, TABLET, FILM COATED, LIQUID, CAPSULE, LIQUID FILLED, SOLUTION, INJECTION, SOLUTION, CAPSULE, TABLET, CHEWABLE, KIT
Routes
INTRAMUSCULAR, INTRAVENOUS, ORAL, TOPICAL
Active Ingredients
DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HCL

Indications and Usage

Uses • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies • runny nose • sneezing • itchy, watery eyes • itching of the nose or throat • temporarily relieves these symptoms of the common cold: • runny nose • sneezing

Warnings

Warnings Do not use • to make a child sleepy • 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 • 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 drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children 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 right away. (1-800-222-1222)