loratadine

FDA Drug Profile — topcare childrens allergy relief, equate loratadine, signature care allergy relief, careone allergy relief, Loratadine

loratadine is listed in the FDA National Drug Code directory with 50 NDC codes, marketed under brand names including topcare childrens allergy relief, equate loratadine, signature care allergy relief. Available dosage forms: tablet, chewable, tablet, orally disintegrating, tablet, solution, capsule, liquid filled.

Drug Details

Generic Name
loratadine
Brand Names
topcare childrens allergy relief, equate loratadine, signature care allergy relief, careone allergy relief, Loratadine, foster and thrive childrens allergy relief, Nuvicare-Allergy Relief Loratadine Tablets, 10 mg, Children Claritin Allergy, childrens allergy relief, Allergy Relief, careone childrens allergy relief, Basic Care Allergy Relief, Claritin, allergy relief, good sense allergy relief, Equaline Childrens Allergy Relief, Gencare-Allergy Relief Loratadine Tablets, 10 mg, good sense childrens allergy relief, Childrens Allergy Relief, Claritin Allergy, non drowsy allergy relief, ALLERGY RELIEF, Topcare Allergy Relief, dg health childrens allergy relief, dg health allergy relief, Berkley and Jensen Childrens Allergy Relief, topcare childrens allergy, Claritin Chewable Cool Mint Flavor, loratadine, Basic Care Childrens Allergy Relief
Application Number
ANDA210033
Sponsor
Topco Associates LLC
NDC Codes
50
Dosage Forms
TABLET, CHEWABLE, TABLET, ORALLY DISINTEGRATING, TABLET, SOLUTION, CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients
LORATADINE

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.