{"active_ingredient":["Active ingredient (in each tablet) Loratadine USP, 5 mg"],"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=\"97.76%\"> <col width=\"32%\"/> <col width=\"66%\"/> <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 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 Botrule \" valign=\"top\"> <paragraph>ask a doctor</paragraph> </td> </tr> <tr> <td styleCode=\"Rrule Botrule Lrule \" valign=\"top\"> <paragraph>consumers with liver or kidney disease</paragraph> </td> <td styleCode=\"Rrule Botrule Lrule \" valign=\"top\"> <paragraph>ask a doctor</paragraph> </td> </tr> </tbody> </table>"],"effective_time":"20190717","id":"48a60b3d-d011-4d0f-84dc-414c713c76ba","inactive_ingredient":["Inactive ingredients aspartame, citric acid anhydrous, colloidal silicon dioxide, D&C red No. 27 aluminum lake, FD&C blue No. 2 aluminum lake, flavor, 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 • sneezing • itchy, watery eyes • 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":["ANDA210088"],"brand_name":["Loratadine"],"generic_name":["LORATADINE"],"is_original_packager":[true],"manufacturer_name":["Ohm Laboratories Inc."],"package_ndc":["51660-753-31"],"product_ndc":["51660-753"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["665078"],"spl_id":["48a60b3d-d011-4d0f-84dc-414c713c76ba"],"spl_set_id":["b83de07d-37f4-42b4-b43e-29173454bef0"],"substance_name":["LORATADINE"],"unii":["7AJO3BO7QN"]},"other_safety_information":["Other information • Phenylketonurics: contains phenylalanine 1.25 mg per tablet. • TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING. • store between 20° to 25°C (68° and 77°F)."],"package_label_principal_display_panel":["Principal Display Panel – 30 Chewable Tablet Blister Pack Carton NDC 51660-753-31 † Compare to the active ingredient of Children’s Claritin® Chewable ages 2 years and older Children’s Loratadine Chewable Tablets USP, 5 mg Antihistamine Indoor & Outdoor Allergies 30 CHEWABLE TABLETS The chewable tablets are to be chewed before swallowing. Grape Flavored Non-Drowsy* 24 Hour Relief Of: • Sneezing • Runny Nose • Itchy, Watery Eyes • Itchy Nose or Throat * When taken as directed. See Drug Facts Panel. † Ohm® is a registered trademark of Sun Pharmaceutical Industries, Inc. All other trademarks are property of their respective owners. Carton label"],"purpose":["Purpose Antihistamine"],"questions":["Questions? call toll-free Monday to Friday 8:30 am to 5:00 pm EST at 1-800-406-7984 . Keep the carton. It contains important information. See end panel for expiration date."],"set_id":"b83de07d-37f4-42b4-b43e-29173454bef0","spl_product_data_elements":["Loratadine Loratadine LORATADINE LORATADINE ASPARTAME ANHYDROUS CITRIC ACID SILICON DIOXIDE D&C RED NO. 27 FD&C BLUE NO. 2 MAGNESIUM STEARATE MANNITOL MICROCRYSTALLINE CELLULOSE STEARIC ACID SODIUM STARCH GLYCOLATE TYPE A POTATO light purple to dark purple 753"],"spl_unclassified_section":["Distributed by: Ohm Laboratories Inc. New Brunswick, NJ 08901 0619"],"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 doctorbefore 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. 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)."]}