Drugplain

Allergy Relief 10 mg/1

Loratadine · TABLET · Valu Merchandisers Company

10 Recalls on Record
Plain English

Allergy Relief is a tablet containing loratadine at 10 mg/1, taken oral. Manufactured by Valu Merchandisers Company.

Key Facts

Brand Name
Allergy Relief
Generic Name
Loratadine
NDC Code (Product)
63941-193
Manufacturer
Valu Merchandisers Company
Strength
10 mg/1
Dosage Form
TABLET
Route
ORAL
Marketing Status
Application #
ANDA210722
Marketing Start
07/01/2020

Recall History

10 Recalls on Record
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 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 II02/07/2014

Ohm Laboratories, Inc.

Defective Container: An unacceptable level of blister defects have been identified in Loratadine and Pseudoephedrine Sulfate Extended Release Tablets, 10 mg/240 mg.

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

P & L Developments, LLC

cGMP Deviations: Firm was notified by their supplier of Cetirizine HCL Oral Solution, USP, 1mg/mL, 4oz, of the voluntary recall that they have initiated due to potential contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

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 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 III11/21/2022

Dr. Reddy's Laboratories, Inc.

Failed dissolution specifications

Terminated

Side Effects Reported to FDA

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

drug ineffective27,596 reports
fatigue23,306 reports
pain19,305 reports
off label use18,404 reports
headache17,809 reports
nausea16,755 reports
dyspnoea16,587 reports
rash14,262 reports
diarrhoea14,014 reports
arthralgia12,990 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 Relief used for?

Allergy Relief contains Loratadine. It is a tablet taken oral. Consult your doctor for specific uses.

Is Allergy Relief a controlled substance?

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

What is the generic name for Allergy Relief?

The generic name for Allergy Relief is Loratadine. There are 11 other brand versions of Loratadine.

What is the NDC code for Allergy Relief 10 mg/1?

The NDC (National Drug Code) for Allergy Relief 10 mg/1 is 63941-193, listed by Valu Merchandisers Company.