Drugplain

topcare allergy and congestion relief 5 mg/1

loratadine, pseudoephedrine sulfate · TABLET, FILM COATED, EXTENDED RELEASE · Topco Associates LLC

No Recall History
Plain English

Topcare Allergy and Congestion Relief is an over-the-counter oral tablet that combines loratadine (an antihistamine) and pseudoephedrine sulfate (a decongestant) to relieve allergy symptoms and nasal congestion. The extended-release formulation allows for prolonged relief with each dose.

Key Facts

Brand Name
topcare allergy and congestion relief
Generic Name
loratadine, pseudoephedrine sulfate
NDC Code (Product)
36800-611
Manufacturer
Topco Associates LLC
Strength
5 mg/1
Dosage Form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Marketing Status
Application #
ANDA076050
Marketing Start
05/18/2018

Recall History

No Recall History

Side Effects Reported to FDA

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

condition aggravated1 reports
depressed mood1 reports
depressive symptom1 reports
drug interaction1 reports
drug-disease interaction1 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 daily with a full glass of water; not more than 1 tablet 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 topcare allergy and congestion relief used for?

Topcare Allergy and Congestion Relief is an over-the-counter oral tablet that combines loratadine (an antihistamine) and pseudoephedrine sulfate (a decongestant) to relieve allergy symptoms and nasal congestion. The extended-release formulation allows for prolonged relief with each dose.

Is topcare allergy and congestion relief a controlled substance?

topcare allergy and congestion relief is not classified as a controlled substance by the DEA.

What is the generic name for topcare allergy and congestion relief?

The generic name for topcare allergy and congestion relief is loratadine, pseudoephedrine sulfate. There are 10 other brand versions of loratadine, pseudoephedrine sulfate.

What is the NDC code for topcare allergy and congestion relief 5 mg/1?

The NDC (National Drug Code) for topcare allergy and congestion relief 5 mg/1 is 36800-611, listed by Topco Associates LLC.