Negara: Amerika Serikat
Bahasa: Inggris
Sumber: NLM (National Library of Medicine)
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN)
DirectRx
ORAL
OTC DRUG
Antihistamine temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: • runny nose • itchy, watery eyes • sneezing • itching of the nose or throat
Abbreviated New Drug Application
LORATADINE- LORATADINE TABLET DIRECTRX ---------- LORATADINE Loratadine 10 mg Antihistamine Do not use if you have ever had an allergic reaction to this product or any of its ingredients 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. 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- 800-222-1222) • do not use if printed foil under cap is broken or missing • store between 20° to 25°C (68° to 77°F) lactose monohydrate, magnesium stearate, povidone, pregelatinized starch 1-800-719-9260 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 Other information do not use if printed foil under cap is broken or missing store at 20°-25°C (68°-77°F) Questions or comments? 1-800-719-9260 temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: allergies: • runny nose • itchy, watery eyes • sneezing • itching of the nose or throat LORATADINE loratadine tablet PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:61919-142(NDC:45802-650) ROUTE OF ADMINISTRATION ORAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE 10 mg INACTIVE INGREDIENTS INGREDIENT NAME STRENGTH MAGNESIUM STEARATE (UNII: 70097M6I30) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) POVIDONE (UNII: FZ989GH94E) PRODUCT CHARACTERISTICS DirectRx COLOR white SCORE no score SHAPE OVAL SIZE 8mm FLAVOR IMPRINT CODE L612 CONTAINS PACKAGING # ITEM CODE PACKAGE DESCRIPTION M Baca dokumen lengkapnya