{"active_ingredient":["Active Ingredient (in each tablet) Cetirizine hydrochloride USP, 5 mg"],"ask_doctor":["Ask a doctor before use if you have 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."],"dosage_and_administration":["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"],"dosage_and_administration_table":["
adults and children 6 years and over1 to 2 tablets once daily depending upon severity of symptoms; do not take more than 2 tablets in 24 hours.
adults 65 years and over1 tablet once a day; do not take more than 1 tablet in 24 hours
children under 6 years of ageask a doctor
consumers with liver or kidney diseaseask a doctor
"],"effective_time":"20220112","id":"5670c6c3-a4ab-4268-917a-99e0579f3079","inactive_ingredient":["Inactive ingredients Anhydrous lactose, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, sodium lauryl sulfate, titanium dioxide, and triacetin"],"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"],"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":{"application_number":["ANDA076677"],"brand_name":["Cetirizine Hydrochloride"],"generic_name":["CETIRIZINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["Mylan Pharmaceuticals Inc."],"package_ndc":["0378-3635-01","0378-3637-01","0378-3637-05"],"product_ndc":["0378-3635","0378-3637"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1014676","1014678"],"spl_id":["5670c6c3-a4ab-4268-917a-99e0579f3079"],"spl_set_id":["487ae0f0-320c-4534-b9e2-0e215f167cea"],"substance_name":["CETIRIZINE HYDROCHLORIDE"],"unii":["64O047KTOA"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 5 mg Allergy NDC 0378-3635-01 Cetirizine HCl Tablets, USP Allergy 5 mg Antihistamine Indoor & Outdoor Allergies 24 Hour Relief of • runny nose • sneezing • itchy, watery eyes • itching of the nose or throat RMX-AR3635A 100 Tablets Tamper Evident: do not use if foil seal under cap is missing, open or broken. Cetirizine Hydrochloride Tablets 5 mg - Front Layer - Bottle Label Cetirizine Hydrochloride Tablets 5 mg - Back of Front Layer - Bottle Label Cetirizine Hydrochloride Tablets 5 mg - Base Layer - Bottle Label","PRINCIPAL DISPLAY PANEL - 10 mg Allergy NDC 0378-3637-01 Cetirizine HCl Tablets, USP Allergy 10 mg Antihistamine Indoor & Outdoor Allergies 24 Hour Relief of • runny nose • sneezing • itchy, watery eyes • itching of the nose or throat RMX-AR3637A 100 Tablets Tamper Evident: do not use if foil seal under cap is missing, open or broken. Active Ingredient (in each tablet) Cetirizine hydrochloride USP, 10 mg Directions adults and children 6 years and over one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms. adults 65 years and over ask a doctor children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor Cetirizine Hydrochloride Tablets 10 mg - Front Layer - Bottle Label Cetirizine Hydrochloride Tablets 10 mg - Back of Front Layer - Bottle Label Cetirizine Hydrochloride Tablets 10 mg - Base Layer - Bottle Label"],"package_label_principal_display_panel_table":["
Directions
adults and children 6 years and overone 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours.A 5 mg product may be appropriate for less severe symptoms.
adults 65 years and overask a doctor
children under 6 years of ageask a doctor
consumers with liver or kidney diseaseask a doctor
"],"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"],"questions":["Questions? Call 1-877-446-3679 (1-877-4-INFO-RX) Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505"],"set_id":"487ae0f0-320c-4534-b9e2-0e215f167cea","spl_product_data_elements":["Cetirizine Hydrochloride cetirizine hydrochloride CETIRIZINE HYDROCHLORIDE CETIRIZINE ANHYDROUS LACTOSE SILICON DIOXIDE HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYDEXTROSE POLYETHYLENE GLYCOL, UNSPECIFIED SODIUM LAURYL SULFATE TITANIUM DIOXIDE TRIACETIN M;C35 Cetirizine Hydrochloride cetirizine hydrochloride CETIRIZINE HYDROCHLORIDE CETIRIZINE ANHYDROUS LACTOSE SILICON DIOXIDE HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYDEXTROSE POLYETHYLENE GLYCOL, UNSPECIFIED SODIUM LAURYL SULFATE TITANIUM DIOXIDE TRIACETIN M;C37"],"spl_unclassified_section":["Other information • store between 20° to 25°C (68° to 77°F)"],"stop_use":["Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away."],"version":"10","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. Ask a doctor before use if you have 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 • 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. 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 • drowsiness may occur • avoid alcoholic drinks • alcohol, sedatives, and tranquilizers may increase drowsiness • be careful when driving a motor vehicle or operating machinery"]}