Drug Facts
Active Ingredients (in each 5 mL)
Diphenhydramine HCl, USP 12.5 mg
Diphenhydramine Hcl Oral Solution
FDA Label NDC 81033-029
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Kesin Pharma Corporation for the product Diphenhydramine Hcl Oral Solution (NDC 81033-029). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, purpose, uses, warnings, do not use, ask a doctor before use if the child has, otc - ask doctor/pharmacist, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antihistamine
Uses
- temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- runny nose
- sneezing
- itching of the nose or throat
- itchy, watery eyes
Warnings
Warnings
Do Not Use
- with any other products containing diphenhydramine, even one used on skin
- to make a child sleepy
Ask A Doctor Before Use If The Child Has
- a breathing problem such as chronic bronchitis
- glaucoma
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if the child is taking sedastives or tranquilizers
When Using This Product
- marked drowsiness may occur
- sedatives and tranquilizers may increase drowsiness
- excitability may occur, especially in children
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Overdose
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- do not take more than directed
- find the right dose on the chart below
- mL = milliliter
- take every 4 to 6 hurs, or as directed by a doctor
- do not take more than 6 doses in 24 hours
| Age (yr) | Doses (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
- store at 20°C to 25°C (68°F to 77°F). Protect from light.
- do not refrigerate
- Do not use this product if printed inner seal is broken or missing.
Inactive Ingredients
cherry flavor, citric acid, methylparaben, monoammonium glcyrrhizinate, potassium citrate, propylene glycol, polyparaben, purified water, sorbitol, sucralose.
Questions Or Comments?
1-833-537-4679
Other
*This product is not manufactured by McNeil Consumer Healthcare, distributer of Benadryl Allergy.
Distributed by:
Kesin Pharma
Oldsmar, FL 34677
Revision 02/2025
Package Label.Principal Display Panel
NDC 81033-029-16
Diphenhydramine HCl
Oral Solution, USP
12.5 mg/5 mL
Antihistamine
Cherry Flavor
16 fl oz. (473 mL)
* Please review the disclaimer below.
