Country: United States
Language: English
Source: NLM (National Library of Medicine)
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN)
A-S Medication Solutions
ORAL
OTC DRUG
Antihistamine temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
Product: 50090-5532 NDC: 50090-5532-5 90 TABLET in a BOTTLE NDC: 50090-5532-0 10 TABLET in a BOTTLE NDC: 50090-5532-4 30 TABLET in a BOTTLE
Abbreviated New Drug Application
LORATADINE- LORATADINE TABLET A-S MEDICATION SOLUTIONS ---------- MAJOR PHARMACEUTICALS ALLERGY 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: • • • • 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) runny nose itchy, watery eyes sneezing itching of the nose or throat 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 • • INACTIVE INGREDIENTS lactose monohydrate, magnesium stearate, povidone, pregelatinized starch QUESTIONS OR COMMENTS? 1-800-719-9260 HOW SUPPLIED Product: 50090-5532 NDC: 50090-5532-5 90 TABLET in a BOTTLE NDC: 50090-5532-0 10 TABLET in a BOTTLE NDC: 50090-5532-4 30 TABLET in a BOTTLE LORATADINE TABLET do not use if printed foil under cap is broken or missing store between 20 to 25 C (68 to 77 F) ° ° ° ° LORATADINE loratadine tablet PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:50090-5532(NDC:0904-6852) 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 LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 7 Read the complete document