{"active_ingredient":["Active ingredient(s) 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."],"do_not_use":["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"],"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"],"dosage_and_administration_table":["<table border=\"1\" cellpadding=\"0\" cellspacing=\"0\"> <tbody> <tr> <td valign=\"top\">adults and children 12 years of age and over <content styleCode=\"bold\"/> </td> <td valign=\"top\">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</td> </tr> <tr> <td valign=\"top\">children under 12 years of age</td> <td valign=\"top\">do not use</td> </tr> <tr> <td valign=\"top\">Adults 65 years of age and older</td> <td valign=\"top\">ask a doctor</td> </tr> <tr> <td valign=\"top\">consumers with kidney disease</td> <td valign=\"top\">ask a doctor</td> </tr> </tbody> </table>"],"effective_time":"20171207","id":"8c74b0a5-6bbc-0f8d-bbda-46d6cb39aea6","inactive_ingredient":["Inactive ingredients corn starch, croscarmellose sodium, colloidal silicon dioxide, ferric oxide, hypromellose, kollidon SR, magnesium stearate, mannitol, powder cellulose, and triethyl citrate."],"indications_and_usage":["Use(s) temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing nasal congestion itchy, watery eyes itching of the nose or throat 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 contacta Poison Control Center right away."],"openfda":{"application_number":["ANDA076667"],"brand_name":["Fexofenadine HCl and Pseudoephedrine HCI"],"generic_name":["FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI"],"manufacturer_name":["HEB"],"original_packager_product_ndc":["55111-447"],"package_ndc":["37808-022-31"],"product_ndc":["37808-022"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["997406"],"spl_id":["8c74b0a5-6bbc-0f8d-bbda-46d6cb39aea6"],"spl_set_id":["0de7fc37-7f46-4e98-d5ac-d31a3c313a62"],"substance_name":["FEXOFENADINE HYDROCHLORIDE","PSEUDOEPHEDRINE HYDROCHLORIDE"],"unii":["2S068B75ZU","6V9V2RYJ8N"]},"package_label_principal_display_panel":["Principal Display Panel Blister carton 30's (6x5 unit-dose)"],"pregnancy_or_breast_feeding":["Pregnancy/Breastfeeding ask a health professional before use."],"purpose":["Purpose Antihistamine Nasal decongestant"],"questions":["Questions or comments? call toll-free 1-888-375-3784 Manufactured by: Dr. Reddy’s Laboratories Limited Bachupally - 500 090 INDIA"],"set_id":"0de7fc37-7f46-4e98-d5ac-d31a3c313a62","spl_product_data_elements":["Fexofenadine HCl and Pseudoephedrine HCI Fexofenadine HCl and Pseudoephedrine HCI FEXOFENADINE HYDROCHLORIDE FEXOFENADINE MANNITOL PSEUDOEPHEDRINE HYDROCHLORIDE PSEUDOEPHEDRINE POWDERED CELLULOSE STARCH, CORN CROSCARMELLOSE SODIUM SILICON DIOXIDE FERRIC OXIDE RED MAGNESIUM STEARATE Hypromelloses TRIETHYL CITRATE R;195 off white to pale yellow one layer and light red to red other layer carton30count"],"spl_unclassified_section":["Other information safety sealed: do not use if carton is opened or if individual blister units are torn or opened this product meets the requirements of USP dissolution test 3."],"stop_use":["Stop use and ask 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"],"storage_and_handling":["Storage store between 20° to 25°C (68° to 77°F)"],"version":"3","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 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. 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 takeas directed (see Directions). Stop use and ask 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 Pregnancy/Breastfeeding ask a health professional before use. Keep out of reach of children In case of overdose, get medical help or contacta Poison Control Center right away."],"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 takeas directed (see Directions)."]}