FDA Label for Diphenhydramine Hcl
View Indications, Usage & Precautions
Diphenhydramine Hcl Product Label
The following document was submitted to the FDA by the labeler of this product Major Pharmaceuticals. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient (In Each 5 Ml)
Diphenhydramine HCl 12.5 mg
Purpose
Antihistamine
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
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
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)
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 |
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.
Inactive Ingredients:
citric acid anhydrous, glycerin, flavoring, purified water, saccharin sodium, sodium benzoate, sodium carboxymethylcellulose, sodium citrate, sorbitol.
Questions Or Comments?
Call 1-800-845-8210
R02/25
Distributed by:
MAJOR® PHARMACEUTICALS
Indianapolis, IN 46268
Principal Display Panel
Delivers 5 mL
NDC0904-7560-41
Diphenydramine HCl Oral Solution USP
12.5 mg/5 mL
Delivers 10 mL
NDC0904-7559-66
Diphenydramine HCl Oral Solution USP
25 mg/10 mL
* Please review the disclaimer below.
