Country: United States
Language: English
Source: NLM (National Library of Medicine)
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN)
Cardinal Health
LORATADINE
LORATADINE 10 mg
OTC DRUG
New Drug Application
LORATADINE- LORATADINE TABLET CARDINAL HEALTH ---------- LORATADINE 10 MG ACTIVE INGREDIENT In each tablet: Loratadine 10 mg PURPOS E Antihistamine KEEP OUT OF REACH OF CHILDREN Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. US ES Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose, sneezing, itchy, watery eyes and itching of the nose or throat. WARNINGS This package is intended for institutional use only. Do not use if you have ever had an allergic reaction to this product or any of its ingredients. If pregnant or breast-feeding, ask a health professional before use. Ask a doctor before use if you have 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 TAMPER EVIDENT FEATURE: Loratadine Tablets are safety sealed. Do not use if imprinted blister unit is open or torn. DIRECTIONS adults and children 6 years and over 1 tablet daily, not more than 1 tablet in 24 hours children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor INACTIVE INGREDIENTS Lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate STORAGE Store at 15-30 C (59-86 F) Protect from excessive moisture Original Prescription Strength *NON-DROWSY 24-Hour Allergy Relief of Sneezing, Runny Nose, Itchy, Watery Eyes and Itchy Throat or Nose *When taken as directed. See Drug Facts. Manufactured and Distributed by: Novartis Consumer Health, Inc. Parsippany, NJ 07054-0622 Questions? call 1-800-452-0051 24 hours a day, 7 days a week Repackaged by Cardinal Health Zanesville, OH 43701 PRINCIPAL DISPLAY PANEL Loratadine 10 mg Antihistamine 10 Tablets LORATADINE loratadine tablet PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SO Read the complete document