Active Ingredient
(in each softgel)
Diphenhydramine Hydrochloride USP 50 mg
Diphenhydramine Hydrochloride Capsule, Liquid Filled
FDA Label NDC 35916-0438
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 35916-0438). 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 active ingredient, otc - purpose, uses, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Nighttime sleep-aid
Uses
for relief of occasional sleeplessness
Do Not Use
for children under 12 years of age
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
avoid alcoholic drinks
Stop Use And Ask A Doctor If
sleeplessness persist continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
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.
Directions
adults and children 12 years of age and over: 1 softgel (50 mg) at bedtime if needed, or as directed by a doctor
Inactive Ingredients
Propylene Glycol, Polyethylene Glycol 600, Polyethylene Glycol 400, Gelatin, Glycerin, Sorbitol Sorbitan Solution, FD & C Blue No.1, Purified Water
Bottle Label
* Please review the disclaimer below.
