{"active_ingredient":["Drug Facts Active ingredients (in each extended release tablet) Cetirizine HCl USP 5 mg Pseudoephedrine HCl USP 120 mg"],"ask_doctor":["Ask a doctor before use if you have heart disease thyroid disease diabetes glaucoma high blood pressure trouble urinating due to an enlarged prostate gland 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."],"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. if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product."],"dosage_and_administration":["Directions do not break or chew tablet; swallow tablet whole adults and children 12 years and over take 1 tablet every 12 hours; do not take more than 2 tablets in 24 hours. adults 65 years and over ask a doctor children under 12 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=\"66%\"><colgroup><col width=\"46.26%\"/><col width=\"53.74%\"/></colgroup><tbody><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\" valign=\"top\">adults and children 12 years and over  </td><td styleCode=\"Rrule\" valign=\"top\">take 1 tablet every 12 hours; 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\">ask a doctor </td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\" valign=\"top\">children under 12 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":"20260825","id":"36996eb4-9195-4bfc-a687-fdb4ea05a860","inactive_ingredient":["Inactive ingredients colloidal silicon dioxide, croscarmellose sodium, ferric oxide, hypromellose, magnesium stearate, microcrystalline cellulose. Questions or comments? call 1-855-274-4122 (Monday - Friday 8:30 AM to 5:00 PM EST) Distributed by: AUROHEALTH LLC 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India"],"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 nasal congestion reduces swelling of nasal passages temporarily relieves sinus congestion and pressure temporarily restores freer breathing through the nose"],"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":["ANDA212409"],"brand_name":["Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride"],"generic_name":["CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["Aurohealth LLC"],"package_ndc":["58602-703-76","58602-703-75","58602-703-53","58602-703-09"],"product_ndc":["58602-703"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1014571"],"spl_id":["36996eb4-9195-4bfc-a687-fdb4ea05a860"],"spl_set_id":["26f2c3c1-a2f2-474a-950a-8cfe07f289fa"],"substance_name":["CETIRIZINE HYDROCHLORIDE","PSEUDOEPHEDRINE HYDROCHLORIDE"],"unii":["64O047KTOA","6V9V2RYJ8N"]},"package_label_principal_display_panel":["PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -5 mg/120 mg (12 x 2) Blister Carton AUROHEALTH NDC 58602-703-09 *Compare to the active ingredients of Zyrtec-D ® Original Prescription Strength Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets, USP 5 mg/120 mg Antihistamine/Nasal Decongestant Indoor & Outdoor Allergies ALLERY + SINUS NASAL CONGESTION + SINUS PRESSURE 12 Hour relief of Sneezing Runny Nose Itchy, Watery Eyes Itchy Throat or Nose Actual Size 24 EXTENDED-RELEASE TABLETS PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -5 mg/120 mg (12 x 2) Blister 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 Nasal decongestant"],"set_id":"26f2c3c1-a2f2-474a-950a-8cfe07f289fa","spl_product_data_elements":["Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride CETIRIZINE HYDROCHLORIDE CETIRIZINE PSEUDOEPHEDRINE HYDROCHLORIDE PSEUDOEPHEDRINE SILICON DIOXIDE CROSCARMELLOSE SODIUM FERRIC OXIDE YELLOW HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE Pale Yellow to Yellow K15"],"stop_use":["Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. you get nervous, dizzy, or sleepless symptoms do not improve within 7 days or are accompanied by fever"],"storage_and_handling":["Other information store between 20° to 25°C (68° to 77°F) do not use if carton is opened or if individual blister units are torn or broken"],"version":"4","warnings":["Warnings"],"when_using":["When using this product do not use more than directed 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."]}