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Diphenhydramine HCl

Dosage form
SOLUTION
Labeler
Major Pharmaceuticals
Label updated
2025-08-01
Retrieved
2026-09-07
Active ingredients
DIPHENHYDRAMINE HYDROCHLORIDE
View original label and images on DailyMed ↗
Label information

Drug Facts

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
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)

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

[Image in the official label — see DailyMed source]

PRINCIPAL DISPLAY PANEL

Delivers 10 mL

NDC0904-7559-66

Diphenydramine HCl Oral Solution USP

25 mg/10 mL

 

[Image in the official label — see DailyMed source]

DailyMed Set ID: 1b591e27-b00b-41c8-9fe9-c633aba09134 · Version 2
NDC: 0904-7559, 0904-7560