Drugplain

Diphenhydramine HCl Oral Solution 12.5 mg/5mL

diphenhydramine hydrochloride · SOLUTION · Natco Pharma USA LLC

3 Recalls on Record
Plain English

Diphenhydramine HCl Oral Solution is a solution containing diphenhydramine hydrochloride at 12.5 mg/5mL, taken oral. Manufactured by Natco Pharma USA LLC.

Key Facts

Brand Name
Diphenhydramine HCl Oral Solution
Generic Name
diphenhydramine hydrochloride
NDC Code (Product)
69339-151
Manufacturer
Natco Pharma USA LLC
Strength
12.5 mg/5mL
Dosage Form
SOLUTION
Route
ORAL
Marketing Status
Application #
M012
Marketing Start
12/14/2020

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 hydrochloride. 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 hydrochloride. There are 12 other brand versions of diphenhydramine hydrochloride.

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 69339-151, listed by Natco Pharma USA LLC.

Product NDC

69339-151

Package NDC

69339-151-17

Other Diphenhydramine Brands

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

Data from openFDA · Public domain (CC0 1.0)