Active Ingredient
(in each gelcap)
Diphenhydramine HCl USP 50 mg
Diphenhydramine Hydrochloride
FDA Label NDC 68016-795
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pharmacy Value Alliance, Llc for the product Diphenhydramine Hydrochloride (NDC 68016-795). 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, 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, 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
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
■ difficulty in urination due to enlargement of the prostate gland
Ask A Doctor Or Pharmacist Before Use If You Are
taking sedatives or tranquilizers
When Using This Product
■ avoid alcoholic beverages
Stop Use And Ask A Doctor If
sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.
If Pregnant Or Breast-Feeding
ask a health professional before use.
Keep Out Of The Reach Of Children
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
adults & children 12 years of age and over: 1 gelcap (50 mg) at bedtime if needed, or as directed by a doctor
Other Information
■ store at 20°-25°C (68°-77°F). See USP Controlled Temperature.
■ avoid high humidity
Inactive Ingredients
ammonium hydroxide, black iron oxide, colloidal silicon dioxide, croscarmellose sodium, D&C red #33, dicalcium phosphate dihydrate, FD&C blue #1, FD&C yellow #6, gelatin, hydroxy propyl cellulose, hypromellose, isopropyl alcohol, lecithin, magnesium stearate, microcrystalline cellulose, n-butyl alcohol, polyethylene glycol, polyvinyl alcohol, propylene glycol, shellac, talc, titanium dioxide, xanthan gum.
Questions Or Comments?
call 1-877-770-3183 Mon-Fri 9:00 AM to 4:30 PM EST
Diphenhydramine Hcl 50 Mg Rr Gelcaps
48 Count (300000401 R 00 Final)
* Please review the disclaimer below.
