{"active_ingredient":["Active ingredient (in each 5 mL) Loratadine 5 mg"],"ask_doctor":["Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose."],"do_not_use":["Do not use if you have ever had an allergic reaction to this product or any of its ingredients."],"dosage_and_administration":["Directions use only with enclosed dosing cup mL=milliliter adults and children 6 years and over 10 mL daily; do not take more than 10 mL in 24 hours children 2 to under 6 years of age 5 mL daily; do not take more than 5 mL in 24 hours children under 2 years of age ask a doctor consumers with liver or kidney disease ask a doctor"],"dosage_and_administration_table":["
adults and children 6 years and over10 mL daily; do not take more than 10 mL in 24 hours
children 2 to under 6 years of age5 mL daily; do not take more than 5 mL in 24 hours
children under 2 years of ageask a doctor
consumers with liver or kidney diseaseask a doctor
"],"effective_time":"20260408","id":"4ef454c5-7e60-4107-e063-6394a90a6f93","inactive_ingredient":["Inactive ingredients artificial peach flavor, citric acid monohydrate, glycerin, propylene glycol, purified water, sodium benzoate, sodium metabisulfite, sucrose"],"indications_and_usage":["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"],"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. (1-800-222-1222)"],"openfda":{"application_number":["ANDA076805"],"brand_name":["Childrens Loratadine"],"generic_name":["LORATADINE"],"is_original_packager":[true],"manufacturer_name":["Sun Pharmaceutical Industries, Inc."],"package_ndc":["51672-2073-8","51672-2073-4","51672-2073-5"],"product_ndc":["51672-2073"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["692783"],"spl_id":["4ef454c5-7e60-4107-e063-6394a90a6f93"],"spl_set_id":["78e11f1c-c8a4-4b2a-b7dc-ae1b2dea26d0"],"substance_name":["LORATADINE"],"unii":["7AJO3BO7QN"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton NDC 51672-2073-8 Children's Loratadine Oral Solution USP, 5 mg/5 mL Carton Principal Display Panel - 120 mL Bottle Carton"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Antihistamine"],"questions":["Questions? Call 1-866-923-4914"],"set_id":"78e11f1c-c8a4-4b2a-b7dc-ae1b2dea26d0","spl_product_data_elements":["Childrens Loratadine Loratadine CITRIC ACID MONOHYDRATE GLYCERIN PROPYLENE GLYCOL WATER SODIUM BENZOATE SODIUM METABISULFITE SUCROSE LORATADINE LORATADINE colorless to slightly yellow peach"],"spl_unclassified_section":["Drug Facts","Distributed by: Ohm Laboratories Inc. New Brunswick, NJ 08901 Made In Israel"],"stop_use":["Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away."],"storage_and_handling":["Other information do not use if bottle wrap imprinted with \"SEALED FOR SAFETY\" is broken or missing. see bottom panel for lot number and expiration date store between 20° and 25°C (68° and 77°F)"],"version":"7","warnings":["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)"],"when_using":["When using this product do not take more than directed. Taking more than directed may cause drowsiness."]}