Actice Ingredient
(in each softgel)
Diphenhydramine Hydrochloride USP 25mg
Diphenhydramine Hydrochloride Capsule, Liquid Filled
FDA Label NDC 35916-0435
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Softgel Healthcare Private Limited for the product Diphenhydramine Hydrochloride (NDC 35916-0435). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding actice ingredient, purpose, uses, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, if pregnant or breast-feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Diphenhydramine Hydrochloride Capsules Usp 25 mg Carton (Diphen.jpg)
* Please review the disclaimer below.
