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Diphenhydramine HCl

Dosage form
SOLUTION
Labeler
PAI Holdings, LLC dba PAI Pharma
Label updated
2024-01-05
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 not 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

Label information

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

Label information

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

Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

Other information
  • each 5 mL contains: sodium 10 mg
  • store between 20-25°C (68-77°F). Protect from light. Store in outer carton until contents used.
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

PRINCIPAL DISPLAY PANEL

Delivers 5 mL

NDC 0121-0865-05

Diphenydramine HCl Oral Solution USP

12.5 mg/5 mL

Antihistamine/Allergy

Alcohol Free/Dye Free/Sugar Free

Package Not Child-Resistant

[Image in the official label — see DailyMed source]

PRINCIPAL DISPLAY PANEL

Delivers 10 mL

NDC 0121-1730-10

Diphenydramine HCl Oral Solution USP

25 mg/10 mL

Antihistamine/Allergy

Alcohol Free/Dye Free/Sugar Free

Package Not Child-Resistant

[Image in the official label — see DailyMed source]

DailyMed Set ID: 3c3e0dc8-cddd-4f46-9b68-19bac00c07cc · Version 5
NDC: 0121-0865, 0121-1730