{"active_ingredient":["Active ingredients 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_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. if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (cer tain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks af ter 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\"><tbody><tr styleCode=\"Botrule First\"><td styleCode=\"Lrule Rrule\" valign=\"middle\">adults and children 12 years and over</td><td styleCode=\"Rrule\" valign=\"middle\">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=\"middle\">adults 65 years and over</td><td styleCode=\"Rrule\" valign=\"middle\">ask a doctor</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\" valign=\"middle\">children under 12 years of age</td><td styleCode=\"Rrule\" valign=\"middle\">ask a doctor</td></tr><tr><td styleCode=\"Lrule Rrule\" align=\"left\" valign=\"middle\">consumers with liver or kidney disease</td><td styleCode=\"Rrule\" valign=\"middle\">ask a doctor</td></tr></tbody></table>"],"effective_time":"20241127","id":"a0bd1e9b-eb9f-46e7-8cee-10bde092d7cb","inactive_ingredient":["Inactive ingredients hydroxyethyl cellulose, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, stearic acid, titanium dioxide Imprinting Ink Contents: ammonium hydroxide, iron oxide black, isopropyl alcohol, N-butyl alcohol, propylene glycol, shellac glaze"],"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":["ANDA090922"],"brand_name":["Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride"],"generic_name":["CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["Sun Pharmaceutical Industries, Inc."],"package_ndc":["62756-915-60","62756-915-62","62756-915-73"],"product_ndc":["62756-915"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1014571"],"spl_id":["a0bd1e9b-eb9f-46e7-8cee-10bde092d7cb"],"spl_set_id":["796c4b81-145b-4050-a851-dec81ff97006"],"substance_name":["CETIRIZINE HYDROCHLORIDE","PSEUDOEPHEDRINE HYDROCHLORIDE"],"unii":["64O047KTOA","6V9V2RYJ8N"]},"package_label_principal_display_panel":["Principal Display Panel - Showbox NDC 62756-915-62 Original Prescription Strength Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride Extended-release Tablets, USP 5 mg/120 mg Antihistamine/Nasal Decongestant Indoor & Outdoor Allergies ALLERGY & SINUS SUN PHARMA Actual Size DO NOT USE IF INDIVIDUAL BLISTER UNIT IS OPEN OR TORN 12 Tablets (2 blister cards of 6 tablets each) 13","Principal Display Panel - Blister pack Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablet, USP 5 mg/120 mg Mfg. by: Sun Pharmaceutical Ind. Ltd. India. spl-cetirizine-pseudoephedrine-blister"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding: if breast-feeding: not recommended if pregnant: ask a health professional before use."],"purpose":["Purposes Antihistamine Nasal decongestant"],"questions":["Questions? Call toll free 1-800-818-4555 weekdays"],"set_id":"796c4b81-145b-4050-a851-dec81ff97006","spl_product_data_elements":["Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride CETIRIZINE HYDROCHLORIDE CETIRIZINE PSEUDOEPHEDRINE HYDROCHLORIDE PSEUDOEPHEDRINE HYDROXYPROPYL CELLULOSE (1600000 WAMW) HYDROXYETHYL CELLULOSE, UNSPECIFIED HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE STEARIC ACID TITANIUM DIOXIDE AMMONIA FERROSOFERRIC OXIDE ISOPROPYL ALCOHOL BUTYL ALCOHOL PROPYLENE GLYCOL SHELLAC circular 915"],"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 the blister unit is broken See side panel for lot number and expiration date"],"version":"11","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"]}