Drugplain

Allergy and Congestion Relief 5 mg/1

loratadine, Pseudoephedrine sulfate · TABLET, FILM COATED, EXTENDED RELEASE · L. Perrigo Company

2 Recalls on Record
Plain English

Allergy and Congestion Relief is a tablet, film coated, extended release containing loratadine, pseudoephedrine sulfate at 5 mg/1, taken oral. Manufactured by L. Perrigo Company.

Key Facts

Brand Name
Allergy and Congestion Relief
Generic Name
loratadine, Pseudoephedrine sulfate
NDC Code (Product)
0113-2007
Manufacturer
L. Perrigo Company
Strength
5 mg/1
Dosage Form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Marketing Status
Application #
ANDA076050
Marketing Start
04/12/2018

Recall History

2 Recalls on Record
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 II03/16/2020

Glaxosmithkline Consumer Healthcare Holdings

Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

drug ineffective150 reports
somnolence32 reports
product use in unapproved indication22 reports
feeling abnormal20 reports
drug effect incomplete18 reports
drug effective for unapproved indication18 reports
dizziness16 reports
dyspnoea15 reports
fatigue12 reports
condition aggravated11 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: • sneezing • itchy, watery eyes • runny nose • itching of the nose or throat • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies • reduces swelling of nasal passages • temporarily relieves sinus congestion and pressure • temporarily restores freer breathing through the nose

Dosage & Administration

Directions • do not divide, crush, chew or dissolve the tablet adults and children 12 years and over 1 tablet every 12 hours; not more than 2 tablets in 24 hours children under 12 years of age ask a doctor consumers with liver or kidney disease ask a doctor

Warnings

Warnings Do not use • if you have ever had an allergic reaction to this product or any of its ingredients • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have • heart disease • thyroid disease • high blood pressure • diabetes • trouble urinating due to an enlarged prostate gland • liver or kidney disease. Your doctor should determine if you need a different dose. When using this product do not take more than directed. Taking more than directed may cause drowsiness. Stop use and ask a doctor if • an allergic reaction to this product occurs. Seek medical help right away. • symptoms do not improve within 7 days or are accompanied by a fever • nervousness, dizziness or sleeplessness occurs If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-

Frequently Asked Questions

What is Allergy and Congestion Relief used for?

Allergy and Congestion Relief contains loratadine, Pseudoephedrine sulfate. It is a tablet, film coated, extended release taken oral. Consult your doctor for specific uses.

Is Allergy and Congestion Relief a controlled substance?

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

What is the generic name for Allergy and Congestion Relief?

The generic name for Allergy and Congestion Relief is loratadine, Pseudoephedrine sulfate. There are 11 other brand versions of loratadine, Pseudoephedrine sulfate.

What is the NDC code for Allergy and Congestion Relief 5 mg/1?

The NDC (National Drug Code) for Allergy and Congestion Relief 5 mg/1 is 0113-2007, listed by L. Perrigo Company.