{"active_ingredient":["ACTIVE INGREDIENTS (in each extended-release tablet) Cetirizine HCl USP 5 mg Pseudoephedrine HCl USP 120 mg"],"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":["
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
"],"effective_time":"20260803","id":"b8b5717a-d6bc-468a-a9ee-ca6b73a13c51","inactive_ingredient":["INACTIVE INGREDIENT"],"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":["ANDA210507"],"brand_name":["Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride"],"generic_name":["CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["Unichem Pharmaceuticals (USA), Inc."],"package_ndc":["29300-313-61","29300-313-24","29300-313-22"],"product_ndc":["29300-313"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1014571"],"spl_id":["b8b5717a-d6bc-468a-a9ee-ca6b73a13c51"],"spl_set_id":["af18ca44-615e-48ef-b678-7a9ae02e0f2a"],"substance_name":["CETIRIZINE HYDROCHLORIDE","PSEUDOEPHEDRINE HYDROCHLORIDE"],"unii":["64O047KTOA","6V9V2RYJ8N"]},"other_safety_information":["OTHER INFORMATION store between 20° to 25°C (68° to 77°F) do not use if blister unit is torn or broken keep the carton. It contains important information."],"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL image [MM2] Container label 12count"],"purpose":["PURPOSE"],"questions":["QUESTIONS"],"set_id":"af18ca44-615e-48ef-b678-7a9ae02e0f2a","spl_product_data_elements":["Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride CETIRIZINE HYDROCHLORIDE CETIRIZINE PSEUDOEPHEDRINE HYDROCHLORIDE PSEUDOEPHEDRINE CELLULOSE, MICROCRYSTALLINE CROSCARMELLOSE SODIUM FERRIC OXIDE YELLOW HYPROMELLOSE 2208 (100000 MPA.S) HYPROMELLOSE 2208 (4000 MPA.S) HYPROMELLOSE 2910 (5 MPA.S) LACTOSE MONOHYDRATE MAGNESIUM STEARATE POLYETHYLENE GLYCOL 400 SILICON DIOXIDE TITANIUM DIOXIDE White to Off White and White to Pale Yellow Biconvex U;313"],"spl_unclassified_section":["DRUG FACTS","Antihistamine Nasal decongestant","colloidal silicon dioxide, croscarmellose sodium, ferric oxide yellow, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide","call 1-866-562-4616 from Monday to Friday between 8.00 AM to 8.00 PM, EST Manufactured by: UNICHEM LABORATORIES LTD. Pilerne Ind. Estate, Pilerne, Bardez, Goa 403511, India. Manufactured for: 12 count- 13013737 03-R-08/2026 24 count- 13013738 03-R-08/2026 East Brunswick, NJ 08816. Unichem logo"],"version":"5","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. 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. 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. 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. Stop use and ask 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 If pregnant or breast-feeding: if breast-feeding: not recommended if pregnant: ask a health professional before use."]}