Drugplain

Banophen 50 mg/1

diphenhydramine hcl · CAPSULE · Preferred Pharmaceuticals Inc.

2 Recalls on Record
Plain English

Banophen is a capsule containing diphenhydramine hcl at 50 mg/1, taken oral. Manufactured by Preferred Pharmaceuticals Inc..

Key Facts

Brand Name
Banophen
Generic Name
diphenhydramine hcl
NDC Code (Product)
68788-7830
Manufacturer
Preferred Pharmaceuticals Inc.
Strength
50 mg/1
Dosage Form
CAPSULE
Route
ORAL
Marketing Status
Application #
341
Marketing Start
01/08/2021

Recall History

2 Recalls on Record
Class II05/21/2019

Torrent Pharma Inc

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

TerminatedVoluntary: Firm initiated
Class II03/15/2021

Cardinal Health Inc.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

completed suicide761 reports
death560 reports
nausea517 reports
fatigue506 reports
pain472 reports
infusion related reaction468 reports
dyspnoea439 reports
diarrhoea426 reports
arthralgia419 reports
headache414 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Use Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies • runny nose • sneezing • itchy, watery eyes • itchy throat and nose • Temporarily relieves these symptoms due to the common cold o runny nose o sneezing

Dosage & Administration

Directions • Take every 4-6 hours • Do not take more than 6 doses in 24 hours adults and children 12 years of age and over Take 1 capsule (50 mg) children under 12 years of age ask a doctor, the proper dosage strength is not available in this package** **Do not attempt to break capsules. The proper dosage strength and dosing information for children under 12 years of age is available on the 25 mg package.

Warnings

WARNINGS Do not use • to make a child sleepy • with any other product containing diphenhydramine, even one used on skin

Frequently Asked Questions

What is Banophen used for?

Banophen contains diphenhydramine hcl. It is a capsule taken oral. Consult your doctor for specific uses.

Is Banophen a controlled substance?

Banophen is not classified as a controlled substance by the DEA.

What is the generic name for Banophen?

The generic name for Banophen is diphenhydramine hcl. There are 12 other brand versions of diphenhydramine hcl.

What is the NDC code for Banophen 50 mg/1?

The NDC (National Drug Code) for Banophen 50 mg/1 is 68788-7830, listed by Preferred Pharmaceuticals Inc..