Drugplain

Allergy 25 mg/1

DIPHENHYDRAMINE HYDROCHLORIDE · CAPSULE · DISCOUNT DRUG MART

10 Recalls on Record
Plain English

Allergy is a capsule containing diphenhydramine hydrochloride at 25 mg/1, taken oral. Manufactured by DISCOUNT DRUG MART.

Key Facts

Brand Name
Allergy
Generic Name
DIPHENHYDRAMINE HYDROCHLORIDE
NDC Code (Product)
53943-113
Manufacturer
DISCOUNT DRUG MART
Strength
25 mg/1
Dosage Form
CAPSULE
Route
ORAL
Marketing Status
Application #
M012
Marketing Start
11/30/2007

Recall History

10 Recalls on Record
Class II08/03/2018

Product Quest Manufacturing LLC

CGMP Deviations: products manufactured under conditions that could impact its product quality.

TerminatedVoluntary: Firm initiated
Class II08/20/2021

Washington Homeopathic Products, Inc.

Out-of-specification test results obtained for identification testing based on HPTLC analysis.

TerminatedVoluntary: Firm initiated
Class I12/12/2025

Medinatura New Mexico, inc.

Microbial Contamination of Non-Sterile Products: The products have been found to contain yeast/mold and microbial contamination identified as Achromobacter.

OngoingVoluntary: 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 II07/27/2021

Perrigo Company PLC

Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.

TerminatedVoluntary: Firm initiated
Class II06/05/2019

Sun Pharmaceutical Industries, Inc.

Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: elevated substance results that were reported above or near the specification limit

TerminatedVoluntary: Firm initiated
Class III01/04/2022

Dr. Reddy's Laboratories, Inc.

Failed Dissolution Specifications

TerminatedVoluntary: Firm initiated
Class II02/09/2023

L. Perrigo Company

Failed Impurities/Degradation Specifications

TerminatedVoluntary: Firm initiated
Class II02/09/2023

L. Perrigo Company

Failed Impurities/Degradation Specifications

TerminatedVoluntary: Firm initiated
Class II06/29/2022

Mckesson Medical-Surgical Inc. Corporate Office

CGMP Deviations: products were stored outside the drug label specifications.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

drug ineffective42,850 reports
fatigue27,553 reports
pain21,715 reports
off label use21,662 reports
headache21,609 reports
nausea20,472 reports
dyspnoea19,321 reports
diarrhoea16,832 reports
rash16,578 reports
dizziness14,866 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: ■ sneezing ■ itching of the nose or throat ■ runny nose ■ itchy watery eyes ■temporarily relieves these symptoms due to the common cold: ■ sneezing ■ runny nose

Dosage & Administration

Directions ■ if needed, take every 4-6 hours ■ do not take more than 6 doses in 24-hours children under 4 years of age Do not use children 4 to under 6 years of age Do not use unless directed by a doctor children 6 to under 12 years of age 1 to 2 teaspoonfuls (5 ml to 10 ml)

Warnings

Warnings Do not use ■ with any other product containing diphenhydramine, even one used on skin ■ to make a child sleepy Ask a doctor before use if the child has ■ glaucoma ■ a breathing problem such as chronic bronchitis

Frequently Asked Questions

What is Allergy used for?

Allergy contains DIPHENHYDRAMINE HYDROCHLORIDE. It is a capsule taken oral. Consult your doctor for specific uses.

Is Allergy a controlled substance?

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

What is the generic name for Allergy?

The generic name for Allergy is DIPHENHYDRAMINE HYDROCHLORIDE. There are 11 other brand versions of DIPHENHYDRAMINE HYDROCHLORIDE.

What is the NDC code for Allergy 25 mg/1?

The NDC (National Drug Code) for Allergy 25 mg/1 is 53943-113, listed by DISCOUNT DRUG MART.