loratadine and pseudoephedrine sulfate

FDA Drug Profile — Loratadine and Pseudoephedrine Sulfate, KIRKLAND SIGNATURE ALLERCLEAR D 24 HR Extended Release

loratadine and pseudoephedrine sulfate is listed in the FDA National Drug Code directory with 4 NDC codes, marketed under brand names including Loratadine and Pseudoephedrine Sulfate, KIRKLAND SIGNATURE ALLERCLEAR D 24 HR Extended Release. Available dosage forms: tablet, extended release, tablet, film coated, extended release.

Drug Details

Generic Name
loratadine and pseudoephedrine sulfate
Brand Names
Loratadine and Pseudoephedrine Sulfate, KIRKLAND SIGNATURE ALLERCLEAR D 24 HR Extended Release
Application Number
ANDA076557
Sponsor
Patheon Puerto Rico, Inc.
NDC Codes
4
Dosage Forms
TABLET, EXTENDED RELEASE, TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients
LORATADINE, PSEUDOEPHEDRINE SULFATE

Indications and 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

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 enlarged prostrate 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 (1-800-222-1222) right away.