{"active_ingredient":["ACTIVE INGREDIENT(S) Loratadine 10 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 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 border=\"0\" cellpadding=\"0\" cellspacing=\"0\"><tbody><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\" valign=\"top\">adults and children 6 years and over</td><td styleCode=\"Rrule\" valign=\"top\"> 1 tablet daily; not more than 1 tablet in 24 hours</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\" valign=\"top\"> children under 6 years of age</td><td styleCode=\"Rrule\" valign=\"top\"> ask a doctor</td></tr><tr><td styleCode=\"Lrule Rrule\" valign=\"top\"> consumers with liver or kidney disease</td><td styleCode=\"Rrule\" valign=\"top\"> ask a doctor</td></tr></tbody></table>"],"effective_time":"20250613","how_supplied":["HOW SUPPLIED Loratadine 10 mg NDC 71335-2431-1: 20 Tablets in a BOTTLE NDC 71335-2431-2: 30 Tablets in a BOTTLE NDC 71335-2431-3: 60 Tablets in a BOTTLE NDC 71335-2431-4: 14 Tablets in a BOTTLE NDC 71335-2431-5: 10 Tablets in a BOTTLE NDC 71335-2431-6: 90 Tablets in a BOTTLE NDC 71335-2431-7: 28 Tablets in a BOTTLE NDC 71335-2431-8: 15 Tablets in a BOTTLE NDC 71335-2431-9: 100 Tablets in a BOTTLE Store between 20º to 25ºC (68º to 77ºF). Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504"],"id":"0d74af21-3ef7-418b-a2ef-78737b0af288","inactive_ingredient":["INACTIVE INGREDIENTS Lactose monohydrate, magnesium stearate, sodium starch glycolate and starch maize pregelatinized"],"indications_and_usage":["USE(S) temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:  runny nose  sneezing  itchy, water 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."],"openfda":{"application_number":["ANDA210722"],"brand_name":["Loratadine"],"generic_name":["LORATADINE"],"manufacturer_name":["Bryant Ranch Prepack"],"original_packager_product_ndc":["70010-162"],"package_ndc":["71335-2431-1","71335-2431-2","71335-2431-3","71335-2431-4","71335-2431-5","71335-2431-6","71335-2431-7","71335-2431-8","71335-2431-9"],"product_ndc":["71335-2431"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["ORAL"],"rxcui":["311372"],"spl_id":["0d74af21-3ef7-418b-a2ef-78737b0af288"],"spl_set_id":["0d74af21-3ef7-418b-a2ef-78737b0af288"],"substance_name":["LORATADINE"],"unii":["7AJO3BO7QN"]},"package_label_principal_display_panel":["Loratadine 10mg Tablet Label"],"pregnancy_or_breast_feeding":["PREGNANCY/BREASTFEEDING ask a health professional before use"],"purpose":["PURPOSE Antihistamine"],"recent_major_changes":[""],"set_id":"0d74af21-3ef7-418b-a2ef-78737b0af288","spl_product_data_elements":["Loratadine Loratadine LACTOSE MONOHYDRATE STARCH, CORN MAGNESIUM STEARATE SODIUM STARCH GLYCOLATE TYPE A POTATO LORATADINE LORATADINE White to off white G;10"],"spl_unclassified_section":["OTHER INFORMATION Tamper-evident: do not use if foil seal under cap, printed with \"SEALED for YOUR PROTECTION\" is missing, open or broken","QUESTIONS OR COMMENTS Contact 1-877-770-3183: Mon-Fri 8:00 AM EST to 5:00 PM PST."],"stop_use":["STOP USE AND ASK DOCTOR IF an allergic reaction to this product occurs. Seek medical help right away."],"storage_and_handling":["STORAGE store between 20º to 25ºC (68º to 77ºF)"],"version":"2","warnings":["WARNINGS DO NOT USE if you have ever had an allergic reaction to this product or any of its ingredients"],"when_using":["WHEN USING THIS PRODUCT do not take more than directed. Taking more than directed may cause drowsiness."]}