Active Ingredient
(in each gelcap)
Diphenhydramine HCl USP, 25 mg
Diphenhydramine Hydrochloride
FDA Label NDC 68016-789
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 68016-789). 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
■ reduces time to fall asleep if you have difficulty falling asleep.
Do Not Use
■ for children under 12 years of age
■ with any other product containing diphenhydramine, even one used on skin
■ with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products
Ask A Doctor Before Use If You Have
■ a breathing problem such as asthma, emphysema, or chronic bronchitis
■ glaucoma
■ difficulty in urination due to enlargement of the prostate gland
■ heart disease
Ask A Doctor Or Pharmacist Before Use If You Are
■ taking sedatives or tranquilizers or any other sleep-aid
When Using This Product
■ avoid alcoholic beverages and other drugs that cause drowsiness
■ drowsiness will occur
■ be careful when driving a motor vehicle or operating machinery
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 Reach Of Children
Keep out of reach of children.
Overdose Warning:
Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
take only one dose per day (24 hours) see Overdose warning
adults & children 12 years and over
2 gelcaps 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 # 28, D&C red # 33, dicalcium phosphate dihydrate, FD&C blue #1, FD&C yellow #6 gelatin, hydroxyl propyl cellulose, hypromellose, iron oxide red, iron oxide yellow, 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.
Package Label.Principal Display Panel
48 Count (300000401 R 00 Final)
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