{"active_ingredient":["Active Ingredient (in each extended release tablet) Cetirizine HCl 5 mg Pseudoephedrine HCl 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) (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":["
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":"20181126","how_supplied":["HOW SUPPLIED Product: 63629-4399"],"id":"fcbc568d-3ce4-49f2-b862-5b338840e178","inactive_ingredient":["Inactive Ingredients Colloidal silicon dioxide, croscarmellose sodium, D & C yellow aluminum lake, hypromellose, iron oxide red, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate, povidone, and titanium dioxide."],"indications_and_usage":["Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose itchy, watery eyes nasal congestion sneezing itching of the nose or throat 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."],"openfda":{},"package_label_principal_display_panel":["Cetrizine Pseudo 5MG/120MG ER Tablet Label Image"],"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"],"questions":["Questions or comments? 1-800-525-8747 Sandoz Inc. Princeton, NJ 08540 05-2010M"],"set_id":"2c766dd8-565d-4e07-b69f-d6176523adb2","spl_product_data_elements":["Cetirizine HCl and Pseudoephedrine HCl ER Cetirizine HCl and Pseudoephedrine HCl CETIRIZINE HYDROCHLORIDE CETIRIZINE PSEUDOEPHEDRINE HYDROCHLORIDE PSEUDOEPHEDRINE SILICON DIOXIDE CROSCARMELLOSE SODIUM D&C YELLOW NO. 10 FERRIC OXIDE RED FERRIC OXIDE YELLOW HYPROMELLOSE 2208 (15000 MPA.S) LACTOSE MONOHYDRATE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POLYSORBATE 80 POVIDONE, UNSPECIFIED TITANIUM DIOXIDE SZ912"],"spl_unclassified_section":["Other Information Safety sealed: do not use if the imprinted bottle seal is open or torn (for bottle only). DO NOT USE IF BLISTER UNIT IS BROKEN OR TORN (for blister package only). Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature)."],"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":["Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature)."],"version":"1004","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 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 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."],"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"]}