{"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=\"100%\"><col width=\"50%\"/><col width=\"50%\"/><tbody><tr><td styleCode=\"Rrule Botrule \" valign=\"top\"><paragraph>adults and children 6 years and over</paragraph></td><td styleCode=\"Botrule Lrule \" 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 Botrule \" valign=\"top\"><paragraph>children 2 to under 6 years of age</paragraph></td><td styleCode=\"Lrule Toprule Botrule \" 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 Botrule \" valign=\"top\"><paragraph>children under 2 years of age</paragraph></td><td styleCode=\"Lrule Toprule Botrule \" valign=\"top\"><paragraph>ask a doctor</paragraph></td></tr><tr><td valign=\"top\"><paragraph>consumers with liver or kidney disease</paragraph></td><td valign=\"top\"><paragraph>ask a doctor</paragraph></td></tr></tbody></table>"],"effective_time":"20260205","id":"4a1a6858-a837-261e-e063-6394a90a3923","inactive_ingredient":["Inactive ingredients edetate disodium, glycerin, maltitol, monobasic sodium phosphate, natural and artificial grape flavor, phosphoric acid, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose"],"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":["ANDA075728"],"brand_name":["Childrens Loratadine Oral"],"generic_name":["LORATADINE"],"manufacturer_name":["Atlantic Biologicals"],"original_packager_product_ndc":["0904-6767"],"package_ndc":["17856-6767-1"],"product_ndc":["17856-6767"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["692783"],"spl_id":["4a1a6858-a837-261e-e063-6394a90a3923"],"spl_set_id":["4a1a6981-133c-d45b-e063-6294a90a4a09"],"substance_name":["LORATADINE"],"unii":["7AJO3BO7QN"]},"package_label_principal_display_panel":["Package/Label Principal Display Panel Compare to the active ingredient in Children’s Claritin ® children’s loratadine oral solution loratadine oral solution USP, 5 mg/5 mL antihistamine allergy indoor & outdoor allergies non-drowsy * 24-hour relief of: • sneezing • runny nose • itchy, watery eyes • itchy throat or nose dye-free sugar-free ages 2 years and older *when taken as directed. See drug facts panel. grape flavor 1"],"pregnancy_or_breast_feeding":["If pregnant or breast feeding, ask a health professional before use."],"purpose":["Purpose Antihistamine"],"questions":["Questions or comments? To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or https://www.fda.gov/medwatch/report.htm DISTRIBUTED BY: ATLANTIC BIOLOGICALS MIAMI,FL 33179"],"set_id":"4a1a6981-133c-d45b-e063-6294a90a4a09","spl_product_data_elements":["Childrens Loratadine Oral Loratadine EDETATE DISODIUM GLYCERIN MALTITOL SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM PHOSPHORIC ACID PROPYLENE GLYCOL WATER SODIUM BENZOATE SORBITOL SUCRALOSE LORATADINE LORATADINE"],"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 carton is opened, or if printed neckband is broken or missing store between 20° to 25°C (68° to 77°F)"],"version":"1","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."]}