{"active_ingredient":["Active ingredient (in each tablet) 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 • chew or crush tablets completely before swallowing adults and children 6 years and over chew 2 tablets daily; not more than 2 tablets in 24 hours children 2 to under 6 years of age chew 1 tablet daily; not more than 1 tablet 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 Lrule Toprule \" valign=\"top\"><paragraph>adults and children 6 years and over</paragraph></td><td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph>chew 2 tablets daily; not more than 2 tablets in 24 hours</paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>children 2 to under 6 years of age</paragraph></td><td styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph>chew 1 tablet daily; not more than 1 tablet in 24 hours</paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>children under 2 years of age</paragraph></td><td styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph>ask a doctor</paragraph></td></tr><tr><td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph>consumers with liver or kidney disease</paragraph></td><td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph>ask a doctor</paragraph></td></tr></tbody></table>"],"effective_time":"20230620","id":"d6a8c36e-4c50-4c16-96a0-2b056a050e17","inactive_ingredient":["Inactive ingredients artificial grape flavor, aspartame, colloidal silicon dioxide, D&C red #27 aluminum lake, FD&C blue #2 aluminum lake, magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate, stearic acid"],"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":["ANDA210033"],"brand_name":["topcare childrens allergy relief"],"generic_name":["LORATADINE"],"is_original_packager":[true],"manufacturer_name":["Topco Associates LLC"],"package_ndc":["36800-363-39","36800-363-49"],"product_ndc":["36800-363"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["665078"],"spl_id":["d6a8c36e-4c50-4c16-96a0-2b056a050e17"],"spl_set_id":["4f7555ea-6286-4ff6-b125-d12660ae4bdf"],"substance_name":["LORATADINE"],"unii":["7AJO3BO7QN"]},"package_label_principal_display_panel":["Principal Display Panel TopCare ® health COMPARE TO CHILDREN’S CLARITIN ® ACTIVE INGREDIENT children’s NON-DROWSY* Allergy Relief LORATADINE CHEWABLE TABLETS, 5 mg • ANTIHISTAMINE INDOOR & OUTDOOR ALLERGIES 24 HOUR RELIEF OF: • Sneezing • Runny Nose • Itchy, Watery Eyes • Itchy Throat or Nose 2 Years & older GRAPE FLAVOR 30 CHEWABLE TABLETS *When taken as directed. See Drug Facts Panel. actual size childrens allergy relief image"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Antihistamine"],"questions":["Questions or comments? 1-888-423-0139"],"set_id":"4f7555ea-6286-4ff6-b125-d12660ae4bdf","spl_product_data_elements":["topcare childrens allergy relief loratadine LORATADINE LORATADINE ASPARTAME SILICON DIOXIDE D&C RED NO. 27 FD&C BLUE NO. 2 MAGNESIUM STEARATE MANNITOL MICROCRYSTALLINE CELLULOSE STEARIC ACID light L3Y8"],"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 • phenylketonurics: contains phenylalanine 1.4 mg per tablet • do not use if blister unit is broken or torn • store between 20 ° to 25 ° C (68 ° to 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."]}