FDA Label for Diphenhydramine Hydrochloride
View Indications, Usage & Precautions
Diphenhydramine Hydrochloride Product Label
The following document was submitted to the FDA by the labeler of this product Softgel Healthcare Private Limited. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Actice Ingredient
(in each softgel)
Diphenhydramine Hydrochloride USP 25mg
Purpose
Antihistamine
Uses
temporarily relieves these symptoms due to hay fever or other upper respiratoryallergies:
runny nose
sneezing
itchy, watery eyes
itching of the nose or throat
temporarily relieves these symptoms due to the common cold:
runny nose
sneezing
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 aPoison Control Center right away. (1-800-222-1222)
Directions
take every 4 to 6 hours
do not take more than 6 doses in 24 hours
adults and children 12 years and over | 1 to 2 capsules |
children 6 to under 12 years | 1 capsule |
children under 6 years | do not use this product in children under 6 years of age |
Other Information
store between 20° to 25°C (68° to 77°F). Avoid high humidity and excessive heat. Protect from light.
do not use if carton is open or blister unit is broken
Inactive Ingredients
Propylene Glycol, Polyethylene Glycol 400, Gelatin, Glycerin, Sorbitol Sorbitan Solution, Purified water.
Package Label.Principal Display Panel
NDC 35916-0435-1
Diphenhydramine Hydrochloride USP 25 mg | Antihistamine
Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat
DYE-FREE
*liquid-filled capsules
Actual Size
BAR CODE
30 CAPSULES
* Please review the disclaimer below.