Diphenhydramine HCl Oral Solution
- Dosage form
- SOLUTION
- Labeler
- Everpharm LLC
- Label updated
- 2025-01-16
- Retrieved
- 2026-09-07
- Active ingredients
- DIPHENHYDRAMINE HYDROCHLORIDE
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