{"active_ingredient":["Active ingredient (in each 5 mL teaspoonful) 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 adults and children 6 years and over 2 teaspoonfuls (tsp) daily; do not take more than 2 teaspoonfuls (tsp) in 24 hours children 2 to under 6 years of age 1 teaspoonful (tsp) daily; do not take more than 1 teaspoonful (tsp) 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":["<table width=\"70%\"><col width=\"26%\"/><col width=\"44%\"/><tbody><tr><td styleCode=\"Rrule Toprule \" valign=\"top\"><paragraph>adults and children 6 years and over</paragraph></td><td styleCode=\"Toprule \" valign=\"top\"><paragraph>2 teaspoonfuls (tsp) daily; do not take more than 2 teaspoonfuls (tsp) in 24 hours</paragraph></td></tr><tr><td styleCode=\"Rrule \" valign=\"top\"><paragraph>children 2 to under 6 years of age</paragraph></td><td valign=\"top\"><paragraph>1 teaspoonful (tsp) daily; do not take more than 1 teaspoonful (tsp) in 24 hours</paragraph></td></tr><tr><td styleCode=\"Rrule \" valign=\"top\"><paragraph>children under 2 years of age</paragraph></td><td valign=\"top\"><paragraph>ask a doctor</paragraph></td></tr><tr><td styleCode=\"Rrule Botrule \" valign=\"top\"><paragraph>consumers with liver or kidney disease</paragraph></td><td styleCode=\"Botrule \" valign=\"top\"><paragraph>ask a doctor</paragraph></td></tr></tbody></table>"],"effective_time":"20260115","id":"db859005-a53d-4de0-aaf8-25c78b746244","inactive_ingredient":["Inactive ingredients butylated hydroxyanisole, glycerin, grape flavor, maltitol solution, masking agent, phosphoric acid, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium phosphate monobasic dihydrate, sorbitol solution, sucralose powder."],"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 Sugar Free"],"generic_name":["LORATADINE"],"manufacturer_name":["Preferred Pharmaceuticals Inc."],"original_packager_product_ndc":["51672-2131"],"package_ndc":["68788-8286-1"],"product_ndc":["68788-8286"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["692783"],"spl_id":["db859005-a53d-4de0-aaf8-25c78b746244"],"spl_set_id":["23936948-71bf-4c18-9160-22b7075e675d"],"substance_name":["LORATADINE"],"unii":["7AJO3BO7QN"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton NDC 68788-8286-1 Compare to the active ingredient in Children's Claritin ® * Original Prescription Strength Children's Loratadine Oral Solution USP, 5 mg/5 mL (Antihistamine) ALLERGY Non-Drowsy † Indoor & Outdoor Allergies SUGAR FREE 24 Hour Relief of: • Sneezing • Runny Nose • Itchy, Watery Eyes • Itchy Throat or Nose Ages 2 years and older Dosing Cup Enclosed Grape Flavor † When taken as directed. See Drug Facts Panel. 4 FL OZ (120 mL) Loratadine Oral Solution 5mg5mL"],"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":"23936948-71bf-4c18-9160-22b7075e675d","spl_product_data_elements":["Childrens Loratadine Sugar Free Loratadine Loratadine Loratadine BUTYLATED HYDROXYANISOLE GLYCERIN SORBITOL POLYETHYLENE GLYCOL, UNSPECIFIED PHOSPHORIC ACID PROPYLENE GLYCOL WATER SODIUM BENZOATE SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE colorless to slightly yellow"],"spl_unclassified_section":["Drug Facts","Distributed by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532 Relabeled By: Preferred Pharmaceuticals Inc."],"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":"4","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."]}