Pharbedryl
Drug Facts
3ef18965-bafb-cc19-e063-6394a90af17d
HUMAN OTC DRUG LABEL
Sep 16, 2025
ST. MARY'S MEDICAL PARK PHARMACY
DUNS: 063050751
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 (10)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
INDICATIONS & USAGE SECTION
Uses
- Temporarily relieves these symptoms associated with the common cold, hay fever, or other respiratory allergies:
- sneezing
- itching of the nose or throat
- runny nose
- itchy, watery eyes
- Temporarily relieves these symptoms due to common cold:
- runny nose
- sneezing
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each capsule)
Diphenhydramine HCl 25mg
Purpose
Antihistamine
WARNINGS SECTION
Warnings
Do not use
- to make child sleepy
- with any other product containing diphenhydramine, even one used on skin
OTC - ASK DOCTOR SECTION
Ask a doctor before use if you have
- trouble urinating due to an enlarged prostate gland
- a breathing problem such as emphysema or chronic bronchitis
- glaucoma
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
- marked drowsiness may occur
- excitability may occur, especially in children
- alcohol, sedatives and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
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 reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away 91-800-222-1222).
DOSAGE & ADMINISTRATION SECTION
Directions
- take every 4 to 6 hours, or as directed by a doctor
- do not take more than 6 times in 24 hours
|
adults and children 12 years and above |
1-2 capsules |
|
children 6 to under 12 years |
1 capsule |
|
children under 6 years |
Ask a doctor |
STORAGE AND HANDLING SECTION
Other information
*Tamper Evident: Do not use if safety seal under cap is broken or missing
- store between 20°-25°C (68°-77°F)
- protect from excessive moisture
INACTIVE INGREDIENT SECTION
Inactive ingredients
black iron oxide, D&C red #28, D&C blue #1, FD&C red #40, gelatin, lactose monohydrate, magnesium stearate, silicon dioxide, sodium lauryl sulfate
OTC - QUESTIONS SECTION
Questions?
Adverse drug event call (866)562-2756 Mon - Fri 8 AM to 4 PM