{"active_ingredient":["Active ingredient (in each tablet) For 5 mg: Cetirizine hydrochloride USP 5 mg For 10 mg: Cetirizine hydrochloride USP 10 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."],"dosage_and_administration":["Directions For 5 mg: adults and children 6 years and over 1 tablet (5 mg) or 2 tablets (10 mg) once daily depending upon severity of symptoms; do not take more than 2 tablets (10 mg) in 24 hours. adults 65 years and over 1 tablet (5 mg) once daily; do not take more than 1 tablet (5 mg) in 24 hours. children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor For 10 mg: 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"],"dosage_and_administration_table":["
adults and children 6 years and over 1 tablet (5 mg) or 2 tablets (10 mg) once daily depending upon severity of symptoms; do not take more than 2 tablets (10 mg) in 24 hours.
adults 65 years and over 1 tablet (5 mg) once daily; do not take more than 1 tablet (5 mg) in 24 hours.
children under 6 years of age ask a doctor
consumers with liver or kidney disease ask a doctor
","
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
"],"effective_time":"20260803","id":"09cf1596-6539-44ff-9f90-a0fb1f218b4e","inactive_ingredient":["Inactive ingredients colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide."],"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. [1-800-222-1222]"],"openfda":{"application_number":["ANDA090760"],"brand_name":["Cetirizine Hydrochloride (Allergy)"],"generic_name":["CETIRIZINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["Aurohealth LLC"],"package_ndc":["58602-444-09","58602-444-17","58602-444-47","58602-444-41","58602-444-21","58602-445-09","58602-445-17","58602-445-47","58602-445-15","58602-445-19","58602-445-94","58602-445-38","58602-445-40","58602-445-41","58602-445-21","58602-445-01","58602-445-60","58602-445-54","58602-445-65","58602-445-23","58602-445-39","58602-812-09","58602-812-17","58602-812-99","58602-812-23","58602-812-39","58602-812-41","58602-812-83","58602-812-04"],"product_ndc":["58602-444","58602-445","58602-812"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1014676","1014678"],"spl_id":["09cf1596-6539-44ff-9f90-a0fb1f218b4e"],"spl_set_id":["3cf969e6-6bc9-4dae-ab6a-b24c0fc46b25"],"substance_name":["CETIRIZINE HYDROCHLORIDE"],"unii":["64O047KTOA"]},"package_label_principal_display_panel":["PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 mg (30's Tablet Container Carton Label) AUROHEALTH NDC 58602-444-09 * Compare to the active ingredient of Zyrtec ® Original Prescription Strength Allergy Relief Cetirizine Hydrochloride Tablets USP 5 mg Antihistamine Indoor & Outdoor Allergies 5 mg Strength Tablets 24 Hour relief of Sneezing Runny Nose Itchy, Watery Eyes Itchy Throat or Nose 30 Tablets 5 mg each PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 mg (30's Tablet Container Carton Label)","PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -5 mg (10 x 10 Blister Carton Label) AUROHEALTH NDC 58602-444-21 * Compare to the active ingredient of Zyrtec ® Allergy Relief Cetirizine Hydrochloride Tablets USP 5 mg Antihistamine Original Prescription Strength Indoor & Outdoor Allergies 5 mg Strength Tablets 24 Hour relief of Sneezing Runny Nose Itchy, Watery Eyes Itchy Throat or Nose 100 (10 x 10) Unit-dose Tablets 5 mg each PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -5 mg (10 x 10 Blister Carton Label)","PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (30's Tablet Container Carton Label) AUROHEALTH NDC 58602-445-09 * Compare to the active ingredient of Zyrtec ® Allergy Relief Cetirizine Hydrochloride Tablets USP 10 mg Antihistamine Original Prescription Strength Indoor & Outdoor Allergies 10 mg Strength Tablets 24 Hour relief of Sneezing Runny Nose Itchy, Watery Eyes Itchy Throat or Nose 30 Tablets 10 mg each PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (30's Tablet Container Carton Label)","PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (10 x 10 Blister Carton Label) AUROHEALTH NDC 58602-445-21 * Compare to the active ingredient of Zyrtec ® Allergy Relief Cetirizine Hydrochloride Tablets USP 10 mg Antihistamine Original Prescription Strength Indoor & Outdoor Allergies 10 mg Strength Tablets 24 Hour relief of Sneezing Runny Nose Itchy, Watery Eyes Itchy Throat or Nose 100 (10x10)Tablets 10 mg each PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (10 x 10 Blister Carton Label)"],"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 1-855-274-4122 Distributed by: AUROHEALTH LLC 279 Princeton-Hightstown, East Windsor, NJ 08520 Made in India"],"set_id":"3cf969e6-6bc9-4dae-ab6a-b24c0fc46b25","spl_product_data_elements":["Cetirizine Hydrochloride (Allergy) Cetirizine Hydrochloride CETIRIZINE HYDROCHLORIDE CETIRIZINE SILICON DIOXIDE CROSCARMELLOSE SODIUM HYPROMELLOSE 2910 (5 MPA.S) LACTOSE MONOHYDRATE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL 400 TITANIUM DIOXIDE White to Off-white X;35 Cetirizine Hydrochloride (Allergy) Cetirizine Hydrochloride CETIRIZINE HYDROCHLORIDE CETIRIZINE SILICON DIOXIDE CROSCARMELLOSE SODIUM HYPROMELLOSE 2910 (5 MPA.S) LACTOSE MONOHYDRATE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL 400 TITANIUM DIOXIDE White to Off-white X;36 Cetirizine Hydrochloride (Allergy) Cetirizine Hydrochloride CETIRIZINE HYDROCHLORIDE CETIRIZINE SILICON DIOXIDE CROSCARMELLOSE SODIUM HYPROMELLOSE 2910 (5 MPA.S) LACTOSE MONOHYDRATE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL 400 TITANIUM DIOXIDE White to Off-white off-rectangular X;2;0"],"spl_unclassified_section":["Drug Facts"],"stop_use":["Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away."],"storage_and_handling":["Other information store between 20° to 25°C (68° to 77°F) TAMPER EVIDENT: DO NOT USE IF FOIL INNER SEAL IMPRINTED WITH \"SEALED FOR YOUR PROTECTION\" IS BROKEN OR MISSING."],"version":"12","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."],"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. in rare cases, you may experience itching after stopping cetirizine. Consult your healthcare provider if this happens."]}