Страна: САЩ
Език: английски
Източник: NLM (National Library of Medicine)
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN)
Aphena Pharma Solutions - Tennessee, LLC
LORATADINE
LORATADINE 10 mg
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 ANTIHISTAMINE- LORATADINE TABLET APHENA PHARMA SOLUTIONS - TENNESSEE, LLC ---------- PERRIGO LORATADINE TABLETS, 10 MG DRUG FACTS ACTIVE INGREDIENT (IN EACH TABLET) Loratadine 10 mg PURPOSE Antihistamine USES 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 WARNINGS 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) 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 OTHER INFORMATION do not use if printed foil under cap is broken or missing store between 20° to 25°C (68° to 77°F) INACTIVE INGREDIENTS lactose monohydrate, magnesium stearate, povidone, pregelatinized starch QUESTIONS OR COMMENTS? 1-800-719-9260 REPACKAGING INFORMATION Please reference the HOW SUPPLIED section listed above for a description of individual drug products listed below. This drug product has been received by Aphena Pharma Solutions - Tennessee, LLC in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below: 10MG NDC 43353-259-60, Bottles of 90 Tablets NDC 43353-259-18, Bottles of 3000 Tablets NDC 43353-259-09, Bottles of 9000 Tablets Store between 20°-25°C (68°-77°F). See U Прочетете целия документ