Country: United States
Language: English
Source: NLM (National Library of Medicine)
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN)
Allegiant Health
ORAL
OTC DRUG
Antihistamine temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: - runny nose - itchy, watery eyes - itching of the nose or throat - sneezing
Abbreviated New Drug Application
ALLERGY RELIEF- LORATADINE TABLET ALLEGIANT HEALTH ---------- 309 - HEALTH A2Z ALLERGY RELIEF ACTIVE INGREDIENT (IN EACH TABLET) Loratadine 10mg PURPOS E Antihistamine US ES temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose itchy, watery eyes itching of the nose or throat sneezing 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. YOU MAY REPORT SIDE EFFECTS TO 1-888-952-0050. PREGNANCY/BREAS TFEEDING IF PREGNANT OR BREAST-FEEDING, ask a health professional before use. KEEP OUT OF REACH OF CHILDREN KEEP OUT OF REACH OF CHILDREN. In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) right away. DIRECTIONS ADULTS AND CHILDREN 6 YEARS AND OVER: 1 tablet daily. no 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 store between 20° to 25°C (68° to 77°F) protect from excessive moisture do not use if imprinted seal under safety cap is broken or missing INACTIVE INGREDIENTS lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate PRINCIPAL DISPLAY PANEL ALLERG Y RELIEF ALLERGY RELIEF loratadine tablet PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:6 9 16 8 -40 7 ROUTE OF ADMINISTRATION ORAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRE NG TH LO RATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE 10 mg INACTIVE INGREDIENTS INGREDIENT NAME STRE NG TH LACTO SE MO NO HYDRATE (UNII: EWQ57Q8 I5X) MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 ) CELLULO SE, MICRO CRYSTAL Read the complete document