Drugplain

Diphenhydramine HCl Oral Solution 25 mg/10mL

Diphenhydramine HCl Oral · SOLUTION · Rising Pharma Holdings, Inc.

3 Recalls on Record
Plain English

Diphenhydramine HCl Oral Solution is a solution containing diphenhydramine hcl oral at 25 mg/10mL, taken oral. Manufactured by Rising Pharma Holdings, Inc..

Key Facts

Brand Name
Diphenhydramine HCl Oral Solution
Generic Name
Diphenhydramine HCl Oral
NDC Code (Product)
57237-318
Manufacturer
Rising Pharma Holdings, Inc.
Strength
25 mg/10mL
Dosage Form
SOLUTION
Route
ORAL
Marketing Status
Application #
M009.50
Marketing Start
12/15/2023

Recall History

3 Recalls on Record
Class II06/07/2022

Plastikon Healthcare LLC

CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.

TerminatedVoluntary: Firm initiated
Class II06/07/2022

Plastikon Healthcare LLC

CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.

TerminatedVoluntary: Firm initiated
Class II04/13/2022

Mckesson Medical-Surgical Inc. Corporate Office

cGMP deviations: Temperature abuse

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

fatigue3,477 reports
off label use3,144 reports
pain3,111 reports
headache3,110 reports
drug ineffective2,809 reports
infusion related reaction2,770 reports
arthralgia2,703 reports
nausea2,683 reports
nasopharyngitis2,384 reports
pneumonia2,296 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

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. 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. There are no other listed brand versions of Diphenhydramine HCl Oral.

What is the NDC code for Diphenhydramine HCl Oral Solution 25 mg/10mL?

The NDC (National Drug Code) for Diphenhydramine HCl Oral Solution 25 mg/10mL is 57237-318, listed by Rising Pharma Holdings, Inc..

Product NDC

57237-318

Package NDC

57237-318-11

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)