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Diphenhydramine HCl Oral Solution

Dosage form
SOLUTION
Labeler
Everpharm LLC
Label updated
2025-01-16
Retrieved
2026-09-07
Active ingredients
DIPHENHYDRAMINE HYDROCHLORIDE
View original label and images on DailyMed ↗
Label information

Drug Facts

Active ingredient per 5 mL (1 Unit Dose)

Diphenhydramine HCl 12.5 mg

Active ingredient per 10 mL (1 Unit Dose)

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

Uses

Temporarily relieves these symptoms due to hay fever or other 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 istaking 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 accidental overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)

Directions

For the 5 mL Unit-Dose: 

• take every 4 to 6 hours, or as directed by a physician

• do not take more than 6 doses in 24 hours

age dose
Children under 2 years of age Do not use
Children 2 to under 6 years of age Do not use unless directed by a doctor
Children 6 to under 12 years of age 5 mL (12.5 mg) to 10 mL (25 mg)

Directions

For the 10 mL Unit-Dose:

• take every 4 to 6 hours, or as directed by a physician
• do not take more than 6 doses in 24 hours

age dose
Children under 6 years of age                    Do not use
Children 6 to under 12 years of age                10 mL (25 mg)
Adults and children 12 years of age and over  10 mL (25 mg) to 20 mL (50 mg) 

Other information

• each 5 mL contains sodium: 3 mg
• store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]
• do not use if lid is torn or broken

Inactive ingredients

Inactive ingredients:  citric acid, flavor, FD&C red#40, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, and sucralose

Questions or comments?

Questions or comments? (866) 838-3774

Label information

Distributed by:

EverPharm, LLC

14A Winthrop St

Marlborough, MA 01752

PRINCIPAL DISPLAY PANEL

EverPharm

NDC 84415-012-01

Diphenhydramine HCL

Oral Solution

Antihistamine

12.5 mg/5 mL

• Alcohol Free

• Sugar Free

• Cherry Flavor

For Institutional Use Only

100 x 5 mL Unit-Dose Cups

[Image in the official label — see DailyMed source]

PRINCIPAL DISPLAY PANEL

EverPharm

NDC 84415-013-01

Diphenhydramine HCL

Oral Solution

Antihistamine

25 mg/10 mL

• Alcohol Free

• Sugar Free

• Cherry Flavor

For Institutional Use Only

100 x 10 mL Unit-Dose Cups

[Image in the official label — see DailyMed source]

DailyMed Set ID: d7aaf874-69ac-49cf-93be-6d4a38b9a557 · Version 1
NDC: 84415-012, 84415-013