Diphenhydramine HCl Oral Solution
Diphenhydramine HCl Oral · Solution · Oral
Active ingredient
Active ingredient per 5 mL (1 Unit Dose) Diphenhydramine HCl 12.5 mg
Purpose
Purpose Antihistamine
Uses
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
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 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 accidental overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)
Do not use
Do not use
• to make a child sleepy
• with any other product containing diphenhydramine, even one used on skin
Ask a doctor before use
Ask a doctor before use if the child has
• a breathing problem such as chronic bronchitis
• glaucoma
Ask a doctor or pharmacist
Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers
When using this product
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
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
Directions
• 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)
Inactive ingredients
Inactive ingredients: citric acid, flavor, FD&C red#40, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, and sucralose
Questions?
Questions or comments? Call 1-844-474-7464
Label text from the FDA structured product label by Rising Pharma Holdings, Inc. (revised Jul 1, 2025). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Diphenhydramine Hydrochloride in 6 products
- Diphenhydramine Hcl in 1 product
Diphenhydramine HCl Oral Solution NDC products (7)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 84415-012 | Diphenhydramine Hydrochloride 12.5 mg/5mL Solution | Everpharm LLC | OTC MONOGRAPH DRUG |
| 84415-013 | Diphenhydramine Hydrochloride 25 mg/10mL Solution | Everpharm LLC | OTC MONOGRAPH DRUG |
| 81033-029 | Diphenhydramine Hcl 12.5 mg/5mL Solution | Kesin Pharma Corporation | OTC MONOGRAPH DRUG |
| 69339-151 | Diphenhydramine Hydrochloride 12.5 mg/5mL Solution | Natco Pharma USA LLC | OTC MONOGRAPH DRUG |
| 69339-152 | Diphenhydramine Hydrochloride 25 mg/10mL Solution | Natco Pharma USA LLC | OTC MONOGRAPH DRUG |
| 57237-317 | Diphenhydramine Hydrochloride 12.5 mg/5mL Solution | Rising Pharma Holdings, Inc. | OTC MONOGRAPH DRUG |
| 57237-318 | Diphenhydramine Hydrochloride 25 mg/10mL Solution | Rising Pharma Holdings, Inc. | OTC MONOGRAPH DRUG |
Frequently asked questions
What is Diphenhydramine HCl Oral Solution used for?
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
Who makes Diphenhydramine HCl Oral Solution?
Diphenhydramine HCl Oral Solution is listed by 4 labelers in the FDA NDC directory, including Everpharm LLC, Kesin Pharma Corporation, Natco Pharma USA LLC, Rising Pharma Holdings, Inc..