{"active_ingredient":["ACTIVE INGREDIENT(S) Active ingredient (in each tablet) Loratadine USP, 10 mg"],"ask_doctor":["ASK A DOCTOR BEFORE USE IF 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 Do not use if you have ever had an allergic reaction to this product or any of its ingredients."],"dosage_and_administration":["DIRECTIONS Directions adults and children 6 years and over 1 tablet daily; not more than 1 tablet in 24 hours children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor"],"dosage_and_administration_table":["<table cellspacing=\"0\" cellpadding=\"0\" border=\"0\"><tbody><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\" valign=\"middle\">adults and children 6 years and over </td><td styleCode=\"Rrule\" valign=\"middle\"> 1 tablet daily; not more than 1 tablet in 24 hours </td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\" valign=\"middle\"> children under 6 years of age</td><td styleCode=\"Rrule\" valign=\"middle\"> ask a doctor</td></tr><tr><td styleCode=\"Lrule Rrule\" valign=\"middle\"> consumers with liver or kidney disease</td><td styleCode=\"Rrule\" valign=\"middle\"> ask a doctor</td></tr></tbody></table>"],"effective_time":"20241125","id":"aa667b5f-a4ac-4129-bae9-f9c1de776629","inactive_ingredient":["Inactive ingredients Inactive ingredients colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate"],"indications_and_usage":["USE(S) 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 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":["ANDA219223"],"brand_name":["Loratadine 10mg"],"generic_name":["LORATADINE 10MG"],"is_original_packager":[true],"manufacturer_name":["MARKSANS PHARMA LIMITED"],"package_ndc":["25000-092-03","25000-092-79","25000-092-81","25000-092-80"],"product_ndc":["25000-092"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["311372"],"spl_id":["aa667b5f-a4ac-4129-bae9-f9c1de776629"],"spl_set_id":["3360d02d-612d-4cc5-acc9-2cc93713c387"],"substance_name":["LORATADINE"],"unii":["7AJO3BO7QN"],"upc":["0325000092795","0325000092801","0325000092818","0325000092030"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL NDC: 25000-092-81 Loratadine Tablets USP, 10 mg 14's count Carton NDC: 25000-092-03 Loratadine Tablets USP, 10 mg 30's count Carton NDC: 25000-092-03 Loratadine Tablets USP, 10 mg 30's count Label NDC: 25000-092-79 Loratadine Tablets USP, 10 mg 150's count Carton NDC: 25000-092-79 Loratadine Tablets USP, 10 mg 150's count Label NDC: 25000-092-80 Loratadine Tablets USP, 10 mg 365's count Label loratadine-tablets-14ct-blister-carton loratadine-tablets-30ct-carton loratadine-tablets-30-ct-label loratadine-tablets-150ct-carton loratadine-tablets-150ct-label loratadine-tablets-365ct-label"],"pregnancy_or_breast_feeding":["PREGNANCY/BREASTFEEDING If pregnant or breast-feeding, ask a health professional before use."],"purpose":["PURPOSE Purpose Antihistamine"],"questions":["Questions or comments? Questions or comments? Call 1-877-376-4271 (weekdays 9 AM to 5 PM) Manufactured for: Time-Cap Labs, Inc. 7 Michael Avenue, Farmingdale, NY 11735 Manufactured by: Marksans Pharma Ltd. Plot No. L-82, L-83 Verna Indl. Estate Verna, Goa-403722 Made in India"],"set_id":"3360d02d-612d-4cc5-acc9-2cc93713c387","spl_product_data_elements":["Loratadine 10mg Loratadine 10mg LORATADINE LORATADINE SILICON DIOXIDE LACTOSE MONOHYDRATE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE 101 SODIUM STARCH GLYCOLATE TYPE A White to off-white 92"],"stop_use":["STOP USE AND ASK DOCTOR IF Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away."],"version":"4","warnings":["WARNINGS Warnings","OTHER REQUIRED WARNINGS Other information For Bottle pack: Tamper-evident: do not use this product if the imprinted foil seal over the mouth of the bottle is cut, torn, broken or missing. For Blister pack: Tamper-evident: do not use if the individual blister unit is open or torn store between 20º to 25º C (68º to 77º F) FDA approved dissolution test specifications differ from USP"],"when_using":["WHEN USING THIS PRODUCT When using this product do not take more than directed. Taking more than directed may cause drowsiness."]}