{"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=\"65%\" styleCode=\"Noautorules\"><col width=\"40%\" align=\"left\" valign=\"top\"/><col width=\"60%\" align=\"left\" valign=\"top\"/><tbody><tr styleCode=\"Botrule\"><td styleCode=\"Rrule Toprule\">adults and children 6 years and over</td><td styleCode=\"Toprule\">2 teaspoonfuls (tsp) daily; do not take more than 2 teaspoonfuls (tsp) in 24 hours</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Rrule\">children 2 to under 6 years of age</td><td>1 teaspoonful (tsp) daily; do not take more than 1 teaspoonful (tsp) in 24 hours</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Rrule\">children under 2 years of age</td><td>ask a doctor</td></tr><tr><td styleCode=\"Rrule\">consumers with liver or kidney disease</td><td>ask a doctor</td></tr></tbody></table>"],"effective_time":"20260714","id":"5698ca72-fe88-2bd1-e063-6394a90aee88","inactive_ingredient":["Inactive ingredients bubble gum flavor, butylated hydroxyanisole, glycerin, maltitol solution, noncrystallizing sorbitol solution, phosphoric acid, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium phosphate monobasic dihydrate, 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":["ANDA201865"],"brand_name":["Childrens Loratadine Sugar Free"],"generic_name":["LORATADINE"],"is_original_packager":[true],"manufacturer_name":["Sun Pharmaceutical Industries, Inc."],"package_ndc":["51672-2108-8","51672-2108-1"],"product_ndc":["51672-2108"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["692783"],"spl_id":["5698ca72-fe88-2bd1-e063-6394a90aee88"],"spl_set_id":["96a76906-58ad-40cd-be27-4ea254e298c5"],"substance_name":["LORATADINE"],"unii":["7AJO3BO7QN"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton Compare to the active ingredient in Children's Claritin ® * NDC 51672-2108-8 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 Bubble Gum Flavor † When taken as directed. See Drug Facts Panel. 4 FL OZ (120 mL) 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":"96a76906-58ad-40cd-be27-4ea254e298c5","spl_product_data_elements":["Childrens Loratadine Sugar Free Loratadine BUTYLATED HYDROXYANISOLE GLYCERIN POLYETHYLENE GLYCOL, UNSPECIFIED SORBITOL PHOSPHORIC ACID PROPYLENE GLYCOL WATER SODIUM BENZOATE SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE LORATADINE LORATADINE colorless to slightly yellow"],"spl_unclassified_section":["Drug Facts","Distributed by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532"],"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 each teaspoonful contains: sodium 5 mg do not use if bottle wrap imprinted with \"SEALED FOR SAFETY\" is broken or missing. store between 20° and 25°C (68° and 77°F) see bottom panel for lot number and expiration date"],"version":"6","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."]}