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diphenhydramine hydrochloride

FDA Drug Profile — Diphenhydramine Hydrochloride, Itch Relief, Diphenhydramine hydrochloride, Diphenhydramine, Diphenhydramine HCl

Drug Details

Generic Name
diphenhydramine hydrochloride
Brand Names
Diphenhydramine Hydrochloride, Itch Relief, Diphenhydramine hydrochloride, Diphenhydramine, Diphenhydramine HCl, TopCare Allergy Relief, childrens allergy, Childrens Benadryl Chewables, Good Neighbor Allergy Relief, Quality Choice Allergy Relief, Diphenhydramine HCl Oral Solution, Up and Up Nighttime Sleep Aid, Simply Sleep, diphenhydramine hydrochloride, equate nighttime sleep aid, Sleep Aid, Kroger Allergy Relief, Benadryl, Benadryl Allergy Liqui-Gels, Discount Drugmart Allergy Relief, Harris Teeter Allergy Relief
Application Number
ANDA080817
Sponsor
Janssen Cilag SpA
NDC Codes
35
Dosage Forms
TABLET, FILM COATED, INJECTION, INJECTION, SOLUTION, LIQUID, CAPSULE, SOLUTION, CAPSULE, LIQUID FILLED, TABLET, CHEWABLE, KIT
Routes
INTRAMUSCULAR, INTRAVENOUS, TOPICAL, ORAL
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 due to 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)