{"active_ingredient":["Active ingredient (in each chewable tablet) Loratadine USP, 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 chewable tablets in 24 hours children 2 to under 6 years of age chew 1 tablet daily; not more than 1 chewable 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=\"60%\" styleCode=\"Noautorules\"><colgroup><col align=\"left\" valign=\"top\" width=\"45%\"/><col align=\"left\" valign=\"top\" width=\"55%\"/></colgroup><tbody><tr><td styleCode=\"Toprule Rrule\">adults and children 6 years and over</td><td styleCode=\"Toprule\">chew 2 tablets daily; not more than 2 chewable tablets in 24 hours</td></tr><tr><td styleCode=\"Toprule Rrule\">children 2 to under 6 years of age</td><td styleCode=\"Toprule\">chew 1 tablet daily; not more than 1 chewable tablet in 24 hours</td></tr><tr><td styleCode=\"Toprule Rrule\">children under 2 years of age</td><td styleCode=\"Toprule\">ask a doctor</td></tr><tr><td styleCode=\"Toprule Rrule\">consumers with liver or kidney disease</td><td styleCode=\"Toprule\">ask a doctor</td></tr></tbody></table>"],"effective_time":"20240315","id":"1389f9d0-c642-8381-e063-6394a90a7a76","inactive_ingredient":["Inactive ingredients aspartame, citric acid anhydrous, colloidal silicon dioxide, 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 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":["ANDA210088"],"brand_name":["DYE-FREE CHILDRENS LORATADINE"],"generic_name":["LORATADINE"],"is_original_packager":[true],"manufacturer_name":["PUBLIX SUPER MARKETS, INC"],"package_ndc":["56062-921-20"],"product_ndc":["56062-921"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["665078"],"spl_id":["1389f9d0-c642-8381-e063-6394a90a7a76"],"spl_set_id":["0b29afdc-3b0f-3958-e063-6394a90a233a"],"substance_name":["LORATADINE"],"unii":["7AJO3BO7QN"],"upc":["0041415512733"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 5 mg Tablet Blister Pack Carton NDC 56062-921-20 FOR AGES 2+ YEARS INDOOR & OUTDOOR ALLERGIES children'sallergy LORATADINE CHEWABLE TABLETS USP, 5 mg ANTIHISTAMINE Non-drowsy* 24-hour relief of: • Sneezing • Runny nose • Itchy, watery eyes • Itchy throat or nose DYE FREE ACTUAL SIZE 20 CHEWABLE TABLETS GRAPE FLAVORED *When taken as directed. See Drug Facts Panel † Compare to the active ingredient of Children's Claritin ® Chewables grape--20"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Antihistamine"],"recent_major_changes":[""],"set_id":"0b29afdc-3b0f-3958-e063-6394a90a233a","spl_product_data_elements":["DYE-FREE CHILDRENS LORATADINE LORATADINE ASPARTAME ANHYDROUS CITRIC ACID SILICON DIOXIDE MAGNESIUM STEARATE MANNITOL MICROCRYSTALLINE CELLULOSE SODIUM STARCH GLYCOLATE TYPE A POTATO STEARIC ACID LORATADINE LORATADINE white to off-white bevelled edge LC5"],"spl_unclassified_section":["Drug Facts","DISTRIBUTED BY PUBLIX SUPER MARKETS, INC., 3300 PUBLIX CORPORATE PARKWAY LAKELAND, FL 33811"],"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 1.25 mg per tablet. TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING. store between 68° to 77°F (20° to 25°C)."],"version":"2","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."]}