Drugplain

Diphenhydramine Hydrochloride 25 mg/1

Diphenhydramine Hydrochloride · TABLET · Precision Dose, Inc.

7 Recalls on Record
Plain English

Diphenhydramine Hydrochloride is a tablet containing diphenhydramine hydrochloride at 25 mg/1, taken oral. Manufactured by Precision Dose, Inc..

Key Facts

Brand Name
Diphenhydramine Hydrochloride
Generic Name
Diphenhydramine Hydrochloride
NDC Code (Product)
68094-018
Manufacturer
Precision Dose, Inc.
Strength
25 mg/1
Dosage Form
TABLET
Route
ORAL
Marketing Status
Application #
M012
Marketing Start
07/15/2019

Recall History

7 Recalls on Record
Class II08/30/2017

Mid Valley Pharmaceutical

CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.

TerminatedVoluntary: Firm initiated
Class II06/18/2013

Novartis Consumer Health

Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.

TerminatedVoluntary: Firm initiated
Class II06/18/2013

Novartis Consumer Health

Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.

TerminatedVoluntary: Firm initiated
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 II08/30/2017

Mid Valley Pharmaceutical

CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.

TerminatedVoluntary: Firm initiated
Class II06/18/2013

Novartis Consumer Health

Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.

TerminatedVoluntary: Firm initiated
Class II03/06/2015

Fusion Pharmaceuticals, LLC

Microbial Contamination of a Non-Sterile Product: Kit component is contaminated with Burkholderia multivorans.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

fatigue3,502 reports
off label use3,161 reports
pain3,137 reports
headache3,111 reports
drug ineffective2,833 reports
infusion related reaction2,774 reports
arthralgia2,720 reports
nausea2,701 reports
nasopharyngitis2,387 reports
pneumonia2,310 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 upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat temporarily relieves these symptoms due to the common cold: runny nose sneezing

Dosage & Administration

Directions take every 4 to 6 hours do not take more than 6 doses in 24 hours adults and children 12 years and over 1 to 2 capsules children 6 to under 12 years 1 capsule children under 6 years do not use this product in children under 6 years of age

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 Diphenhydramine Hydrochloride used for?

Diphenhydramine Hydrochloride contains Diphenhydramine Hydrochloride. It is a tablet taken oral. Consult your doctor for specific uses.

Is Diphenhydramine Hydrochloride a controlled substance?

Diphenhydramine Hydrochloride is not classified as a controlled substance by the DEA.

What is the generic name for Diphenhydramine Hydrochloride?

The generic name for Diphenhydramine Hydrochloride is Diphenhydramine Hydrochloride. There are 11 other brand versions of Diphenhydramine Hydrochloride.

What is the NDC code for Diphenhydramine Hydrochloride 25 mg/1?

The NDC (National Drug Code) for Diphenhydramine Hydrochloride 25 mg/1 is 68094-018, listed by Precision Dose, Inc..