{"active_ingredient":["Active ingredient (in each tablet) Loratadine USP, 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.","Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away."],"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 (24 Hour Relief) 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 width=\"100%\"> <col width=\"50%\"/> <col width=\"50%\"/> <tbody> <tr> <td styleCode=\"Rrule Botrule Toprule \"> <paragraph>adults and children 6 years and over</paragraph> </td> <td styleCode=\"Botrule Toprule \"> <paragraph>1 tablet daily; not more than 1 tablet in 24 hours</paragraph> </td> </tr> <tr> <td styleCode=\"Rrule Botrule \"> <paragraph>children under 6 years of age</paragraph> </td> <td styleCode=\"Botrule \"> <paragraph>ask a doctor</paragraph> </td> </tr> <tr> <td styleCode=\"Rrule Botrule \"> <paragraph>consumers with liver or kidney disease</paragraph> </td> <td styleCode=\"Botrule \"> <paragraph>ask a doctor</paragraph> </td> </tr> </tbody> </table>"],"effective_time":"20110701","id":"b428507c-8701-4365-afcc-617191109e0f","inactive_ingredient":["Inactive ingredients Anhydrous lactose, colloidal silicon dioxide, corn starch, hypromellose, magnesium stearate, microcrystalline cellulose, povidone and sodium lauryl sulfate."],"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."],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL NDC 51079-538-20 LORATADINE TABLETS, USP 10 mg Antihistamine 100 Tablets (10 x 10) Original Prescription Strength Non-Drowsy * * When taken as directed. See enclosed leaflet . Indoor and Outdoor Allergies 24 Hour Relief (See Uses section of enclosed leaflet) TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING Drug Facts Active Ingredient (in each tablet) Purpose Loratadine USP, 10 mg . . . . . . . . . . . Antihistamine Uses See enclosed leaflet Warnings See enclosed leaflet Directions See enclosed leaflet Other Information • TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING. • store between 20° to 25°C (68° to 77°F) ̣̣ • protect from excessive moisture Inactive ingredients Anhydrous lactose, colloidal silicon dioxide, corn starch, hypromellose, magnesium stearate, microcrystalline cellulose, povidone and sodium lauryl sulfate. Manufactured by: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. S-10315 R1 Packaged and Distributed by: UDL LABORATORIES, INC. ROCKFORD, IL 61103 This unit dose package is not child resistant. For institutional use only. Keep this and all drugs out of the reach of children. This container provides light-resistance. See window for lot number and expiration date. Loratadine Tablets 10 mg Unit Carton"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Antihistamine"],"questions":["Questions or comments? 1-800-848-0462 • Serious side effects associated with use of this product may be reported to this number. Manufactured by: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Distributed by: UDL Laboratories, Inc. Rockford, IL 61103 S-10314 R1 7/11"],"set_id":"34d4c2dc-5cbd-42f2-9334-b95b02187974","spl_product_data_elements":["Loratadine loratadine LORATADINE LORATADINE ANHYDROUS LACTOSE SILICON DIOXIDE STARCH, CORN HYPROMELLOSES MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POVIDONES SODIUM LAURYL SULFATE white to off-white M;L;17"],"spl_unclassified_section":["Original Prescription Strength Non-Drowsy Indoor and Outdoor Allergies TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.","Other information • TAMPER EVIDENT: DO NOTUSE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING. • store between 20° to 25°C (68° to 77°F) • protect from excessive moisture"],"version":"7","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."],"when_using":["When using this product do not take more than directed. Taking more than directed may cause drowsiness."]}