{"active_ingredient":["Active ingredient (in each tablet) For 5 mg: Cetirizine hydrochloride 5 mg For 10 mg: Cetirizine hydrochloride 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."],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives."],"do_not_use":["Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine."],"dosage_and_administration":["Directions For 5 mg: adults and children 6 years and over 1 to 2 tablets once daily depending upon severity of symptoms; do not take more than 2 tablets in 24 hours. adults 65 years and over 1 tablet once a day; do not take 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 For 10 mg: adults and children 6 years and over one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms. adults 65 years and over ask a doctor children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor Other information • store between 20° to 25°C (68° to 77°F) Questions or comments? call toll free 1-800-818-4555 weekdays"],"dosage_and_administration_table":["<table cellpadding=\"0pt\" cellspacing=\"0pt\" width=\"65%\"> <col width=\"32%\"/> <col width=\"32%\"/> <tbody> <tr> <td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"> <paragraph>adults and children 6 years and over  </paragraph> </td> <td styleCode=\"Rrule Botrule Toprule \" valign=\"top\"> <paragraph>1 to 2 tablets once daily depending upon severity of symptoms; do not take more than 2 tablets in 24 hours.  </paragraph> </td> </tr> <tr> <td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"> <paragraph>adults 65 years and over  </paragraph> </td> <td styleCode=\"Rrule Botrule \" valign=\"top\"> <paragraph>1 tablet once a day; do not take more than 1 tablet in 24 hours  </paragraph> </td> </tr> <tr> <td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"> <paragraph>children under 6 years of age  </paragraph> </td> <td styleCode=\"Rrule 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 \" valign=\"top\"> <paragraph>ask a doctor    </paragraph> </td> </tr> </tbody> </table>","<table cellpadding=\"0pt\" cellspacing=\"0pt\" width=\"80%\"> <col width=\"32%\"/> <col width=\"46%\"/> <tbody> <tr> <td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"> <paragraph>adults and children 6 years and over    </paragraph> </td> <td styleCode=\"Rrule Botrule Toprule \" valign=\"top\"> <paragraph>one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms.  </paragraph> </td> </tr> <tr> <td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"> <paragraph>adults 65 years and over  </paragraph> </td> <td styleCode=\"Rrule Botrule \" valign=\"top\"> <paragraph>ask a doctor    </paragraph> </td> </tr> <tr> <td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"> <paragraph>children under 6 years of age  </paragraph> </td> <td styleCode=\"Rrule 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 \" valign=\"top\"> <paragraph>ask a doctor    </paragraph> </td> </tr> </tbody> </table>"],"effective_time":"20191216","id":"70fb7362-8d55-4883-8b99-55ad14e0cd29","inactive_ingredient":["Inactive Ingredients Inactive ingredients corn starch, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, titanium dioxide"],"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."],"openfda":{},"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 5 mg 30 Tablets NDC 57664-540-83 Cetirizine Hydrochloride Tablets, 5 mg Antihistamine ALLERGY 30 Tablets Caraco Pharmaceutical Laboratories, Ltd. Cetirizine hydrochloride-5 mg","PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 5 mg 30 Tablets NDC 57664-540-83 Cetirizine Hydrochloride Tablets, 5 mg Antihistamine ALLERGY 30 Tablets Caraco Pharmaceutical Laboratories, Ltd. Cetirizine hydrochloride-5 mg","PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 10 mg 30 Tablets NDC 57664-541-83 Cetirizine Hydrochloride Tablets, 10 mg Antihistamine ALLERGY 30 Tablets Caraco Pharmaceutical Laboratories, Ltd. Cetirizine hydrochloride-10 mg","PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 10 mg 30 Tablets NDC 57664-541-83 Cetirizine Hydrochloride Tablets, 10 mg Antihistamine ALLERGY 30 Tablets Caraco Pharmaceutical Laboratories, Ltd. Cetirizine hydrochloride-10 mg"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding: • If breast-feeding: not recommended • if pregnant: ask a health professional before use."],"purpose":["Purpose Antihistamine"],"set_id":"0d46aa05-d4b7-4380-89e7-859b6ee221b4","spl_product_data_elements":["Cetirizine Hydrochloride Cetirizine Hydrochloride CETIRIZINE HYDROCHLORIDE CETIRIZINE MICROCRYSTALLINE CELLULOSE STARCH, CORN POVIDONE, UNSPECIFIED MAGNESIUM STEARATE HYPROMELLOSE, UNSPECIFIED POLYETHYLENE GLYCOL, UNSPECIFIED POLYSORBATE 80 TITANIUM DIOXIDE white Barrel 540;C Cetirizine Hydrochloride Cetirizine Hydrochloride CETIRIZINE HYDROCHLORIDE CETIRIZINE MICROCRYSTALLINE CELLULOSE STARCH, CORN POVIDONE, UNSPECIFIED MAGNESIUM STEARATE HYPROMELLOSE, UNSPECIFIED POLYETHYLENE GLYCOL, UNSPECIFIED POLYSORBATE 80 TITANIUM DIOXIDE white Barrel 541;C"],"spl_unclassified_section":["Drug Facts"],"stop_use":["Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away."],"version":"3","warnings":["Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine. Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose. Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives. When using this product • drowsiness may occur • avoid alcoholic drinks • alcohol, sedatives, and tranquilizers may increase drowsiness • be careful when driving a motor vehicle or operating machinery. Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding: • If breast-feeding: not recommended • if pregnant: 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 • drowsiness may occur • avoid alcoholic drinks • alcohol, sedatives, and tranquilizers may increase drowsiness • be careful when driving a motor vehicle or operating machinery."]}