DIPHENHYDRAMINE HYDROCHLORIDE
Diphenhydramine Hydrochloride Capsules USP 50 mg (Dye-free)
3b1ea33b-8460-31cf-e063-6394a90a5534
HUMAN OTC DRUG LABEL
Jul 30, 2025
Prodose, Inc.
DUNS: 119371190
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
DIPHENHYDRAMINE HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (8)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Bulk Package Label
INDICATIONS & USAGE SECTION
Uses
- for relief of occasional sleeplessness
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you are
taking sedatives or tranquilizers
OTC - WHEN USING SECTION
When using this product
avoid alcoholic drinks
OTC - STOP USE SECTION
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.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding,
ask a health professional before use.
DOSAGE & ADMINISTRATION SECTION
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 INGREDIENT SECTION
Inactive ingredients
gelatin, glycerin, polyethylene glycol 400, polyethylene glycol 600, propylene glycol, purified water, sorbitol sorbitan solution.
OTC - ACTIVE INGREDIENT SECTION
Active ingredient
(in each softgel)
Diphenhydramine Hydrochloride USP 50 mg
OTC - PURPOSE SECTION
Purpose
Nighttime sleep-aid
WARNINGS SECTION
Warnings
Do not use
- for children under 12 years of age
- with any other product containing diphenhydramine, even one used on skin
OTC - ASK DOCTOR SECTION
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