{"active_ingredient":["ACTIVE INGREDIENT (IN EACH TABLET) Cetirizine HCl, 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."],"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 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"],"dosage_and_administration_table":["<table width=\"100%\"> <col width=\"25%\"/> <col width=\"75%\"/> <tbody> <tr> <td styleCode=\"Rrule Botrule Lrule Toprule \"> <paragraph>adults and children 6 years and over</paragraph> </td> <td styleCode=\"Rrule Botrule Toprule \"> <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 \"> <paragraph>adults 65 years and over</paragraph> </td> <td styleCode=\"Rrule Botrule \"> <paragraph>ask a doctor</paragraph> </td> </tr> <tr> <td styleCode=\"Rrule Lrule Botrule \"> <paragraph>children under 6 years of age</paragraph> </td> <td styleCode=\"Rrule Botrule \"> <paragraph>ask a doctor</paragraph> </td> </tr> <tr> <td styleCode=\"Rrule Botrule Lrule \"> <paragraph>consumers with liver or kidney disease</paragraph> </td> <td styleCode=\"Rrule Botrule \"> <paragraph>ask a doctor</paragraph> </td> </tr> </tbody> </table>"],"effective_time":"20180824","id":"62e359b6-7269-4672-9db1-0e9abc63afb3","inactive_ingredient":["INACTIVE INGREDIENTS corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, talc, 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 (1-800-222-1222)."],"openfda":{"application_number":["ANDA077498"],"brand_name":["Cetirizine Hydrochloride"],"generic_name":["CETIRIZINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["Chain Drug Consortium, LLC"],"package_ndc":["68016-939-54","68016-939-30","68016-939-60","68016-939-90"],"product_ndc":["68016-939"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1014678"],"spl_id":["62e359b6-7269-4672-9db1-0e9abc63afb3"],"spl_set_id":["9d7d2342-a594-4851-810b-b7bce1bd07dc"],"substance_name":["CETIRIZINE HYDROCHLORIDE"],"unii":["64O047KTOA"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 10 mg Tablet Bottle Carton COMPARE TO THE ACTIVE INGREDIENT IN ZYRTEC ® * Original Prescription Strength Premier Value ® 24 Hour Allergy Relief Cetirizine HCl Tablets, USP 10 mg Antihistamine Indoor & Outdoor Allergies Relief of: ✓ Sneezing ✓ Runny nose ✓ Itchy, watery eyes ✓ Itchy throat or nose 90 Tablets 10 mg Each INDEPENDENTLY TESTED PV SATISFACTION GUARANTEED PRINCIPAL DISPLAY PANEL - 10 mg Tablet Bottle Carton"],"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"],"questions":["QUESTIONS? call 1-800-406-7984 Keep the carton. It contains important information. See end panel for expiration date. Distributed By: Pharmacy Value Alliance, LLC 407 East Lancaster Avenue, Wayne, PA 19087"],"set_id":"9d7d2342-a594-4851-810b-b7bce1bd07dc","spl_product_data_elements":["Cetirizine Hydrochloride Cetirizine Hydrochloride CETIRIZINE HYDROCHLORIDE CETIRIZINE STARCH, CORN HYPROMELLOSE, UNSPECIFIED LACTOSE MONOHYDRATE MAGNESIUM STEARATE TALC TITANIUM DIOXIDE POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE, UNSPECIFIED rounded-off R152"],"spl_unclassified_section":["OTHER INFORMATION • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE. (for bottle cartons/stand-alone labels only) • TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING. (for blister cartons only) • store between 20° to 25° C (68° to 77° F)"],"stop_use":["Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away."],"version":"4","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 (1-800-222-1222)."],"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"]}