Diphenhydramine HCl Oral Solution 12.5 mg/5mL
Diphenhydramine HCl Oral Solution · SOLUTION · Kesin Pharma Corporation
Diphenhydramine HCl Oral Solution is a solution containing diphenhydramine hcl oral solution at 12.5 mg/5mL, taken oral. Manufactured by Kesin Pharma Corporation.
Key Facts
- Brand Name
- Diphenhydramine HCl Oral Solution
- Generic Name
- Diphenhydramine HCl Oral Solution
- NDC Code (Product)
81033-029- Manufacturer
- Kesin Pharma Corporation
- Strength
- 12.5 mg/5mL
- Dosage Form
- SOLUTION
- Route
- ORAL
- Marketing Status
- Application #
- M012
- Marketing Start
- 03/04/2025
Recall History
Plastikon Healthcare LLC
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Plastikon Healthcare LLC
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
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
Dosage & Administration
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)
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)
Frequently Asked Questions
What is Diphenhydramine HCl Oral Solution used for?
Diphenhydramine HCl Oral Solution contains Diphenhydramine HCl Oral Solution. It is a solution taken oral. Consult your doctor for specific uses.
Is Diphenhydramine HCl Oral Solution a controlled substance?
Diphenhydramine HCl Oral Solution is not classified as a controlled substance by the DEA.
What is the generic name for Diphenhydramine HCl Oral Solution?
The generic name for Diphenhydramine HCl Oral Solution is Diphenhydramine HCl Oral Solution. There are no other listed brand versions of Diphenhydramine HCl Oral Solution.
What is the NDC code for Diphenhydramine HCl Oral Solution 12.5 mg/5mL?
The NDC (National Drug Code) for Diphenhydramine HCl Oral Solution 12.5 mg/5mL is 81033-029, listed by Kesin Pharma Corporation.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)