{"active_ingredient":["Active ingredients (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 overtake 1 tablet every 12 hours; do not take more than 2 tablets in 24 hours.adults 65 years and overask a doctorchildren under 12 years of ageask a doctorconsumers with liver or kidney diseaseask a doctor
"],"effective_time":"20250212","id":"cf50d4ee-e05e-477a-b543-4ba232e53c80","inactive_ingredient":["Inactive ingredients colloidal silicon dioxide, hypromellose, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, 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 • nasal congestion • 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. (1-800-222-1222)"],"openfda":{"application_number":["ANDA210719"],"brand_name":["Rugby Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride"],"generic_name":["CETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["Rugby Laboratories"],"package_ndc":["0536-1279-12","0536-1279-35"],"product_ndc":["0536-1279"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1014571"],"spl_id":["cf50d4ee-e05e-477a-b543-4ba232e53c80"],"spl_set_id":["5c6ac9a2-4f0a-4297-9b83-988d54598f75"],"substance_name":["CETIRIZINE HYDROCHLORIDE","PSEUDOEPHEDRINE HYDROCHLORIDE"],"unii":["64O047KTOA","6V9V2RYJ8N"]},"other_safety_information":["Other information • store between 20° to 25°C (68° to 77°F) • do not use if blister unit is broken or torn • see side panel for lot number and expiration date • meets USP Dissolution Test 2"],"package_label_principal_display_panel":["Package/Label Principal Display Panel Rugby ® Compare to Zyrtec-D ® active ingredients Original Prescription Strength Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets 5 mg/120 mg Antihistamine/Nasal Decongestant Indoor + Outdoor Allergies Allergy + Sinus Actual Size 12 Hour Relief Nasal Congestion + Sinus Pressure Sneezing; Itchy, Watery Eyes; Runny Nose; Itchy Nose or Throat 12 Extended-Release Tablets rugby-cetirizine-hydrochloride-carton-image.jpg"],"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? 1-800-645-2158"],"set_id":"5c6ac9a2-4f0a-4297-9b83-988d54598f75","spl_product_data_elements":["Rugby Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride Cetirizine hydrochloride, Pseudoephedrine hydrochloride CETIRIZINE HYDROCHLORIDE CETIRIZINE PSEUDOEPHEDRINE HYDROCHLORIDE PSEUDOEPHEDRINE SILICON DIOXIDE HYPROMELLOSE, UNSPECIFIED LACTOSE MONOHYDRATE LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL, UNSPECIFIED TALC TITANIUM DIOXIDE L147"],"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"],"version":"3","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. (1-800-222-1222)"],"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"]}