{"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=\"60%\"><col width=\"40%\" align=\"left\" valign=\"top\"/><col width=\"60%\" align=\"left\" valign=\"top\"/><tbody><tr styleCode=\"Botrule\"><td styleCode=\"Rrule\">adults and children 6 years and over</td><td>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":"5698c3d7-d47a-25e7-e063-6394a90a2d82","inactive_ingredient":["Inactive ingredients artificial grape 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":["51672-2085-8","51672-2085-4","51672-2085-5","51672-2085-1"],"product_ndc":["51672-2085"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["692783"],"spl_id":["5698c3d7-d47a-25e7-e063-6394a90a2d82"],"spl_set_id":["12c8066a-3429-481e-b63a-7ea2b439a170"],"substance_name":["LORATADINE"],"unii":["7AJO3BO7QN"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton NDC xxxxx-xxxx-x Compare to the active ingredient in Children's Claritin ® * GRAPE FLAVOR Original Prescription Strength Ages two years and older Children's Loratadine Syrup (Loratadine Oral Solution) 5 mg/5 mL Antihistamine Grape Flavored Syrup 24 Hour Non-Drowsy † Allergy Relief Indoor & Outdoor Allergies Relief of: Sneezing; Runny Nose, Itchy, Watery Eyes, Itchy Throat or Nose 4 FL OZ (120 mL) † When taken as directed. See Drug Facts Panel. 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":"12c8066a-3429-481e-b63a-7ea2b439a170","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"],"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 do not use if carton is opened, or if imprinted safety seal is broken or missing see bottom panel for expiration date store between 20° to 25°C (68° to 77°F)"],"version":"5","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."]}