{"active_ingredient":["OTC - ACTIVE INGREDIENT (in each tablet) Cetirizine HCl 5 mg"],"ask_doctor":["OTC - ASK DOCTOR liver or kidney disease. Your doctor should determine if you need a different dose."],"ask_doctor_or_pharmacist":["OTC - ASK DOCTOR/PHARMACIST before use if you are taking tranquilizers or sedatives."],"effective_time":"20160908","how_supplied":["HOW SUPPLIED Cetirizine Hydrochloride Tablets, USP 5 mg are supplied as white to off-white,square tablets, debossed “APO 5mg” on obverse and plain on the reverse. They are available as follows: Bottles of 100: NDC 60505-2632-1"],"id":"3c01f0d7-c496-3d71-e054-00144ff8d46c","inactive_ingredient":["INACTIVE INGREDIENT Corn starch, hypromellose, lactose monohydrate, macrogol, magnesium stearate, povidone and titanium dioxide."],"keep_out_of_reach_of_children":["OTC - 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":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION DRUG: CETIRIZINE HYDROCHLORIDE GENERIC: CETIRIZINE HYDROCHLORIDE DOSAGE: TABLET ADMINSTRATION: ORAL NDC: 49349-088-02 STRENGTH:5 mg COLOR: white SHAPE: SQUARE SCORE: No score SIZE: 6 mm IMPRINT: APO;5 QTY: 30 MM1 MM2"],"pregnancy_or_breast_feeding":["OTC - PREGNANCY OR BREAST FEEDING if breast-feeding: not recommended if pregnant: ask a health professional before use."],"purpose":["OTC - PURPOSE Antihistamine"],"set_id":"ffc6089e-503b-4435-ad1e-f55aef630941","spl_product_data_elements":["CETIRIZINE HYDROCHLORIDE CETIRIZINE HYDROCHLORIDE STARCH, CORN HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE POVIDONE TITANIUM DIOXIDE POLYETHYLENE GLYCOL CETIRIZINE HYDROCHLORIDE CETIRIZINE TABLET APO;5"],"stop_use":["OTC - STOP USE if an allergic reaction to this product occurs. Seek medical help right away."],"storage_and_handling":["STORAGE AND HANDLING Store between 20 to 25 C (68 to 77 F)"],"version":"102","warnings":["WARNINGS Do not use if you have ever had an allergic reactions to this product or any of its ingredients or to an antihistamine containing hydroxyzine."],"when_using":["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","OTC - WHEN USING drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery","DIRECTIONS 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"],"when_using_table":["<table width=\"486\" ID=\"i0fe24afe-f9d5-462a-856c-009f995cac4d\"> <tbody> <tr> <td>adults and children 6 years and over</td> <td>1 to 2 tablets once daily; depending upon severity of symptoms; do not take more than 2 tablets in 24 hours </td> </tr> <tr> <td>adults 65 years and over</td> <td>1 tablet once a day; do not take more than 1 tablet in 24 hours</td> </tr> <tr> <td>children under 6 years of age </td> <td>ask a doctor </td> </tr> <tr> <td>consumers with liver or kidney disease </td> <td>ask a doctor </td> </tr> </tbody> </table>"]}