{"active_ingredient":["Drug Facts Active ingredients (in each tablet) Fexofenadine HCl USP 60 mg Pseudoephedrine HCl USP 120 mg"],"ask_doctor":["Ask a doctor before use if you have heart disease thyroid disease glaucoma high blood pressure diabetes trouble urinating due to an enlarged prostate gland kidney disease. Your doctor should determine if you need a different dose."],"dosage_and_administration":["Directions do not divide, crush, chew or dissolve the tablet; swallow tablet whole adults and children 12 years of age and over take 1 tablet with a glass of water every 12 hours on an empty stomach; do not take more than 2 tablets in 24 hours children under 12 years of age do not use adults 65 years of age and older ask a doctor consumers with kidney disease ask a doctor Other information safety sealed: do not use if carton is opened or if individual blister units are torn or opened. store at 20-25°C (68-77°F). Meets USP dissolution test 7"],"dosage_and_administration_table":["
adults and children 12 years of age and over take 1 tablet with a glass of water every 12 hours on an empty stomach; do not take more than 2 tablets in 24 hours
children under 12 years of age do not use
adults 65 years of age and older ask a doctor
consumers with kidney disease ask a doctor
"],"effective_time":"20240506","id":"cc6df813-9175-4c0b-a8e4-afcaa3aa833f","inactive_ingredient":["Inactive ingredients colloidal silicon dioxide, croscarmellose sodium, ferric oxide yellow, hydroxypropyl cellulose, hypromellose, lactose monohydrate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch (maize), stearic acid Questions or Comments? call 1-855-274-4122 IMPORTANT: Read the directions and warnings before use. Keep the carton, it contains important information. Distributed by: RUGBY ® LABORATORIES Indianapolis, IN 46268 (800) 616-2471 Made in India"],"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 temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies 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 (1-800-222-1222) right away."],"openfda":{"application_number":["ANDA209116"],"brand_name":["Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride"],"generic_name":["FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["Rugby Laboratories"],"package_ndc":["0536-1431-34","0536-1431-07"],"product_ndc":["0536-1431"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["997406"],"spl_id":["cc6df813-9175-4c0b-a8e4-afcaa3aa833f"],"spl_set_id":["cc6df813-9175-4c0b-a8e4-afcaa3aa833f"],"substance_name":["FEXOFENADINE HYDROCHLORIDE","PSEUDOEPHEDRINE HYDROCHLORIDE"],"unii":["2S068B75ZU","6V9V2RYJ8N"]},"package_label_principal_display_panel":["PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 2 x 10 Blister Carton Rugby ® Non-Drowsy NDC 0536-1431-34 Compare to the active ingredients in Allegra-D ® 12 Hour Allergy & Congestion Tablets * Allergy & Congestion Fexofenadine HCl and Pseudoephedrine HCl Extended-Release Tablets, USP 60 mg/120 mg Antihistamine and Nasal Decongestant 12 Hour Indoor / Outdoor Relief of: Nasal and Sinus Congestion Due to Colds or Allergies Sneezing; Runny Nose; Itchy, Watery Eyes and Itchy Nose or Throat Due to Allergies 20 Extended Release Tablets fexofenadine-fig1"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Antihistamine Nasal decongestant"],"set_id":"cc6df813-9175-4c0b-a8e4-afcaa3aa833f","spl_product_data_elements":["Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride FEXOFENADINE HYDROCHLORIDE FEXOFENADINE PSEUDOEPHEDRINE HYDROCHLORIDE PSEUDOEPHEDRINE SILICON DIOXIDE CROSCARMELLOSE SODIUM FERRIC OXIDE YELLOW HYPROMELLOSE 2208 (100000 MPA.S) MICROCRYSTALLINE CELLULOSE LACTOSE MONOHYDRATE HYDROXYPROPYL CELLULOSE (110000 WAMW) POLYETHYLENE GLYCOL 6000 POLYETHYLENE GLYCOL 400 STARCH, CORN STEARIC ACID White to Off White Layer and Yellow to Pale Yellow Bincovex Z;79"],"stop_use":["Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. symptoms do not improve within 7 days or are accompanied by a fever you get nervous, dizzy, or sleepless"],"version":"1","warnings":["Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients 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. if you have difficulty swallowing"],"when_using":["When using this product do not take more than directed do not take at the same time as aluminum or magnesium antacids do not take with fruit juices (see Directions ) the tablet coating may be seen in the stool (this is normal). Continue to take as directed (see Directions )."]}