{"active_ingredient":["Active Ingredient Active Ingredient (in each tablet) Purpose Cetirizine HCl 10 mg Antihistamine"],"active_ingredient_table":["
Active Ingredient (in each tablet)Purpose
Cetirizine HCl 10 mgAntihistamine
"],"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 sedatives or tranquilizers."],"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 & Children 6 years and over One 10mg tablet once daily; do not take more than one 10mg 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 ask a doctor Consumers with liver or kidney disease ask a doctor"],"effective_time":"20241115","id":"26f56cb7-be59-a0c2-e063-6294a90a15fa","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. Keep out of reach of children."],"openfda":{"application_number":["ANDA209274"],"brand_name":["Pentrexcilina Day time"],"generic_name":["CETIRIZINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["OPMX LLC"],"package_ndc":["69729-137-14"],"product_ndc":["69729-137"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1014678"],"spl_id":["26f56cb7-be59-a0c2-e063-6294a90a15fa"],"spl_set_id":["26f56cb7-be58-a0c2-e063-6294a90a15fa"],"substance_name":["CETIRIZINE HYDROCHLORIDE"],"unii":["64O047KTOA"]},"overdosage":["OVERDOSE WARNING: In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms."],"package_label_principal_display_panel":["Daytime Xtreme Allergy Relief Cetirizine HCl 10mg Non-Drowsy NDC 69729-137-14 14 Tablets DUO PACK PENTREXCILINA ALL DAY & ALL NIGHT 24 HOUR ALLERGY RELIEF OF: Sneezing/ Estornudos Runny nose/ Escurrimiento nasal Itchy, watery eyes/ Irritación y ojos llorosos Itchy throat/ Picazón en garganta Nighttime Severe Allergy Relief Sleep-aid Diphenhydramine HCl 25mg NDC 69729-106-14 14 Caplets Made for RRX Exclusively distributed by: OPMX Chula Vista CA 91910 Phone: 619-600-5632 Principal display panel All day Pentrexcilina display panel"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Antihistamine"],"questions":["Questions or comments? Call (619) 600-5632 Monday through Friday 9 AM- 5 PM EST"],"set_id":"26f56cb7-be58-a0c2-e063-6294a90a15fa","spl_product_data_elements":["Pentrexcilina Day time Cetirizine Hydrochloride MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED LACTOSE MONOHYDRATE CROSCARMELLOSE SODIUM CETIRIZINE HYDROCHLORIDE CETIRIZINE HYPROMELLOSE, UNSPECIFIED TITANIUM DIOXIDE SILICON DIOXIDE MAGNESIUM STEARATE G;4"],"spl_unclassified_section":["Drug Facts 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 tore at room temperature between 20-25°C (68-77°F). close cap tightly after use. contains no ingredients made from a gluten-containing grain (wheat, barley or rye). TAMPER EVIDENT: Do not use if imprinted safety seal is broken or missing"],"version":"1","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 sedatives or tranquilizers. 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, ask a health professional before use. Keep out of reach of children. Keep out of reach of children. OVERDOSE WARNING: In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms."],"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"]}