Diphenhydramine HCl
Nighttime Sleep-Aid
2914504a-ed42-4168-9e5c-f49407ed5a30
HUMAN OTC DRUG LABEL
May 20, 2025
BI-MART
DUNS: 027630078
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Diphenhydramine HCl
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (12)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL
INDICATIONS & USAGE SECTION
Uses
• for the relief of occasional sleeplessness
• reduces time to fall asleep if you have difficulty falling asleep
OTC - ACTIVE INGREDIENT SECTION
Drug Facts
Active ingredient (in each 30 mL dose cup)
Diphenhydramine HCl 50mg
OTC - PURPOSE SECTION
Purpose
Nightime 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
• with other drugs that cause drowsiness such as antihistamines and nighttime
cold/flu products
OTC - ASK DOCTOR SECTION
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
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 beverages
OTC - STOP USE SECTION
Stop use and ask a doctor if
sleeplessness persists continuosly for more than 2 weeks. Insomnia may be a symptom of serious underlying medical ilness.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding,
ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of the reach of children.
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
DOSAGE & ADMINISTRATION SECTION
Directions
• take only one dose (30 mL) per day (24 hours)
• only use dose cup provided
|
Age |
Dose |
|
adults and children 12 years and over |
30 mL at bedtime if needed or as directed by a doctor |
|
children under 12 years |
do not use |
OTHER SAFETY INFORMATION
Other information
•**each 30 mL dose cup contains:**sodium 24 mg
• store between 15-30°C (59-86°F).
INACTIVE INGREDIENT SECTION
Inactive ingredients
anhydrous citric acid, FD&C Blue #1, FD&C Red #40, flavor, glycerin, menthol, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose.
OTC - QUESTIONS SECTION
Questions or comments?
1-844-912-4012