{"active_ingredient":["Active ingredient (in each tablet) For 5 mg: Cetirizine hydrochloride USP 5 mg For 10 mg: Cetirizine hydrochloride 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. hives that are an unusual color, look bruised or blistered hives that do not itch"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives."],"do_not_use":["Do not use to prevent hives from any known cause such as: foods insect stings medicines latex or rubber gloves because this product will not stop hives from occurring. Avoiding the cause of your hives is the only way to prevent them. Hives can sometimes be serious. If you do not know the cause of your hives, see your doctor for a medical exam. Your doctor may be able to help you find a cause. 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"],"dosage_and_administration_table":["<table cellspacing=\"0\" cellpadding=\"0\" border=\"0\" width=\"768.74\"><colgroup><col width=\"44.8096885813149%\"/><col width=\"55.1903114186851%\"/></colgroup><tbody><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\" valign=\"top\">adults and children 6 years and over </td><td styleCode=\"Rrule\" valign=\"top\">1 to 2 tablets once daily depending upon severity of symptoms; do not take more than 2 tablets in 24 hours </td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\" valign=\"top\">adults 65 years and over </td><td styleCode=\"Rrule\" valign=\"top\">1 tablet once a day; do not take 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>","<table cellspacing=\"0\" cellpadding=\"0\" border=\"0\" width=\"776.72\"><colgroup><col width=\"45.3767123287671%\"/><col width=\"54.6232876712329%\"/></colgroup><tbody><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\" valign=\"top\">adults and children 6 years and over </td><td styleCode=\"Rrule\" valign=\"top\">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. </td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\" valign=\"top\">adults 65 years and over </td><td styleCode=\"Rrule\" valign=\"top\">ask a doctor </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":"20260803","id":"9e202d7d-9a96-448b-bd71-bd7234b9e2a2","inactive_ingredient":["Inactive ingredients colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide"],"indications_and_usage":["Uses reduces hives and relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occurring."],"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":["ANDA090760"],"brand_name":["Cetirizine Hydrochloride (Hives Relief)"],"generic_name":["CETIRIZINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["Aurohealth LLC"],"package_ndc":["58602-446-09","58602-446-17","58602-446-47","58602-446-41","58602-446-21","58602-447-09","58602-447-17","58602-447-47","58602-447-41","58602-447-21","58602-813-09","58602-813-17","58602-813-99","58602-813-23","58602-813-39","58602-813-41","58602-813-04","58602-813-83"],"product_ndc":["58602-446","58602-447","58602-813"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1014676","1014678"],"spl_id":["9e202d7d-9a96-448b-bd71-bd7234b9e2a2"],"spl_set_id":["2b9ac0cd-9dd1-4f78-a16d-9d40f5091c0a"],"substance_name":["CETIRIZINE HYDROCHLORIDE"],"unii":["64O047KTOA"]},"package_label_principal_display_panel":["PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 mg (30's Tablet Container Carton Label) AUROHEALTH NDC 58602-446-09 *Compare to the active ingredient of Zyrtec ® HIVES RELIEF Cetirizine Hydrochloride Tablets USP 5 mg Antihistamine Original Prescription Strength HIVES RELIEF 24 Hour relief Reduces Hives Reduces Itching Due to Hives 30 Tablets 5 mg each PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 mg (30's Tablet Container Carton Label)","PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 mg (10 x 10 Blister Carton Label) AUROHEALTH NDC 58602-446-21 *Compare to the active ingredient of Zyrtec ® HIVES RELIEF Cetirizine Hydrochloride Tablets USP 5 mg Antihistamine Original Prescription Strength HIVES RELIEF 24 Hour relief Reduces Hives Reduces Itching Due to Hives 100 (10x10's) Unit dose Tablets 5 mg each PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 mg (10 x 10 Blister Carton Label)","PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (30's Tablet Container Carton Label) AUROHEALTH NDC 58602-447-09 *Compare to the active ingredient of Zyrtec ® HIVES RELIEF Cetirizine Hydrochloride Tablets USP 10 mg Antihistamine Original Prescription Strength HIVES RELIEF 24 Hour relief Reduces Hives Reduces Itching Due to Hives 30 Tablets 10 mg each Actual Size PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (30's Tablet Container Carton Label)","PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (10 x 10 Blister Carton Label) AUROHEALTH NDC 58602-447-21 *Compare to the active ingredient of Zyrtec ® HIVES RELIEF Cetirizine Hydrochloride Tablets USP10 mg Antihistamine Original Prescription Strength HIVES RELIEF 24 Hour relief ReducesHives Reduces Itching Due to Hives 100 Tablets (10x10 Unit-dose) 10 mg each Actual Size PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (10 x 10 Blister Carton Label)"],"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 1-855-274-4122 Important: Read all product information before using. Keep this carton for important information. Distributed by: AUROHEALTH LLC 279 Princeton-Hightstown Road East Windsor, NJ 08520"],"set_id":"2b9ac0cd-9dd1-4f78-a16d-9d40f5091c0a","spl_product_data_elements":["Cetirizine Hydrochloride (Hives Relief) Cetirizine Hydrochloride CETIRIZINE HYDROCHLORIDE CETIRIZINE SILICON DIOXIDE CROSCARMELLOSE SODIUM HYPROMELLOSE 2910 (5 MPA.S) LACTOSE MONOHYDRATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOL 400 TITANIUM DIOXIDE White to Off-white X;35 Cetirizine Hydrochloride (Hives Relief) Cetirizine Hydrochloride CETIRIZINE HYDROCHLORIDE CETIRIZINE SILICON DIOXIDE CROSCARMELLOSE SODIUM HYPROMELLOSE 2910 (5 MPA.S) LACTOSE MONOHYDRATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOL 400 TITANIUM DIOXIDE White to Off-white X;36 Cetirizine Hydrochloride (Hives Relief) Cetirizine Hydrochloride CETIRIZINE HYDROCHLORIDE CETIRIZINE SILICON DIOXIDE CROSCARMELLOSE SODIUM HYPROMELLOSE 2910 (5 MPA.S) LACTOSE MONOHYDRATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOL 400 TITANIUM DIOXIDE White to Off-white off-rectangular X;2;0"],"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. symptoms do not improve after 3 days of treatment. the hives have lasted more than 6 weeks."],"storage_and_handling":["Other information store between 20° to 25°C (68° to 77°F) TAMPER EVIDENT: DO NOT USE IF FOIL INNER SEAL IMPRINTED WITH \"SEALED FOR YOUR PROTECTION\" IS BROKEN OR MISSING."],"version":"7","warnings":["Warnings Severe Allergy Warning: Get emergency help immediately if you have hives along with any of the following symptoms: trouble swallowing dizziness or loss of consciousness swelling of tongue swelling in or around mouth trouble speaking drooling wheezing or problems breathing These symptoms may be signs of anaphylactic shock. This condition can be life threatening if not treated by a health professional immediately . Symptoms of anaphylactic shock may occur when hives first appear or up to a few hours later. Not a Substitute for Epinephrine. If your doctor has prescribed an epinephrine injector for \"anaphylaxis\" or severe allergy symptoms that could occur with your hives, never use this product as a substitute for the epinephrine injector. If you have been prescribed an epinephrine injector, you should carry it with you at all times."],"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 in rare cases, you may experience itching after stopping cetirizine. Consult your healthcare provider if this happens."]}