Diphenhydramine HCl
Diphenyhydramine HCl Oral Solution, USP
1b591e27-b00b-41c8-9fe9-c633aba09134
HUMAN OTC DRUG LABEL
Aug 1, 2025
Major Pharmaceuticals
DUNS: 191427277
Products 2
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 (9)
diphenhydramine hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (9)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL
Delivers 10 mL
NDC0904-7559-66
Diphenydramine HCl Oral Solution USP
25 mg/10 mL
INDICATIONS & USAGE SECTION
Uses
- temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- runny nose
- sneezing
- itchy, watery eyes
- itching of the nose or throat
OTC - PURPOSE SECTION
Purpose
Antihistamine
OTC - QUESTIONS SECTION
Questions or comments?
Call 1-800-845-8210
R02/25
Distributed by:
MAJOR® PHARMACEUTICALS
Indianapolis, IN 46268
SPL UNCLASSIFIED SECTION
Other information
- each 5 mL contains: sodium 10 mg
- store between 20° to 25°C (68° to 77°F).
Diphenhydramine HCl Oral Solution, USP is a clear, cherry flavored liquid supplied in the following:
NDC 0904-7560-41: 5 mL unit dose cup, in a tray of 10 cups.
NDC 0904-7559-66: 10 mL unit dose cup, in a tray of 10 cups.
OTC - ACTIVE INGREDIENT SECTION
Active ingredient
(in each 5 mL)
Diphenhydramine HCl 12.5 mg
WARNINGS SECTION
Warnings
Do no use
- to make a child sleepy
- with any other product containing diphenhydramine, even one used on skin
Ask a doctor before use if the child has
- a breathing problem such as chronic bronchitis
- glaucoma
Ask a doctor or pharmacist before use if the child is taking sedatives or
tranquilizers
When using this product
- marked drowsiness may occur
- sedatives and tranquilizers may increase drowsiness
- excitability may occur, especially in children
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
DOSAGE & ADMINISTRATION SECTION
Directions:
- find right dose on chart below
- mL = milliliter
- take every 4 to 6 hours, or as directed by a doctor
- do not take more than 6 doses in 24 hours
|
Age (yr) |
Dose (mL) |
|---|---|
|
children under 2 years |
do not use |
|
children 2 to 5 years |
do not use unless directed by a doctor |
|
children 6 to 11 years |
5 mL to 10 mL |
INACTIVE INGREDIENT SECTION
Inactive ingredients:
citric acid anhydrous, glycerin, flavoring, purified water, saccharin sodium, sodium benzoate, sodium carboxymethylcellulose, sodium citrate, sorbitol.