{"active_ingredient":["Active ingredients (in each extended-release 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."],"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 width=\"70%\"><col width=\"45%\" align=\"left\" valign=\"top\"/><col width=\"55%\" align=\"left\" valign=\"top\"/><tbody><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\">adults and children 12 years of age and over</td><td styleCode=\"Rrule\">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 styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\">children under 12 years of age</td><td styleCode=\"Rrule\">do not use</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\">adults 65 years of age and older</td><td styleCode=\"Rrule\">ask a doctor</td></tr><tr><td styleCode=\"Lrule Rrule\">consumers with kidney disease</td><td styleCode=\"Rrule\">ask a doctor</td></tr></tbody></table>"],"effective_time":"20241010","id":"aac48a0b-2b28-4c14-9baa-84c08713e6c2","inactive_ingredient":["Inactive ingredients colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, ethyl cellulose, ferric oxide yellow, hypromellose, lactose monohydrate, magnesuim stearate, microcrystalline cellulose, polyethylene glycol, povidone, stearic acid."],"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."],"openfda":{"application_number":["ANDA090818"],"brand_name":["Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride"],"generic_name":["FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["PUBLIX SUPER MARKETS, INC"],"package_ndc":["41415-995-20","41415-995-30"],"product_ndc":["41415-995"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["997406"],"spl_id":["aac48a0b-2b28-4c14-9baa-84c08713e6c2"],"spl_set_id":["75236b23-af51-40b6-ad1b-f62a27093a16"],"substance_name":["FEXOFENADINE HYDROCHLORIDE","PSEUDOEPHEDRINE HYDROCHLORIDE"],"unii":["2S068B75ZU","6V9V2RYJ8N"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 20 Tablet Blister Pack Carton NDC 41415-995-20 12-HOUR • NON-DROWSY allergyreliefD FEXOFENADINE HCl 60 mg/ANTIHISTAMINE PSEUDOEPHEDRINE HCl 120 mg/NASAL DECONGESTANT EXTENDED-RELEASE TABLETS, USP ORIGINAL PRESCRIPTION STRENGTH ALLERGY & CONGESTION 12-hour relief of: • Nasal and sinus congestion due to colds or allergies • Sneezing • Runny nose • Itchy, watery eyes • Itchy throat or nose due to allergies INDOOR AND OUTDOOR ALLERGIES 20 EXTENDED-RELEASE TABLETS ACTUAL SIZE *Compare to the active ingredients of Allegra-D ® Do not use if individual blister unit is open or torn. PRINCIPAL DISPLAY PANEL - 20 Tablet Blister Pack Carton","PRINCIPAL DISPLAY PANEL - 30 Tablet Blister Pack Carton NDC 41415-995-30 12-HOUR • NON-DROWSY allergyreliefD FEXOFENADINE HCl 60 mg/ANTIHISTAMINE PSEUDOEPHEDRINE HCl 120 mg/NASAL DECONGESTANT EXTENDED-RELEASE TABLETS, USP ORIGINAL PRESCRIPTION STRENGTH ALLERGY & CONGESTION 12-hour relief of: • Nasal and sinus congestion due to colds or allergies • Sneezing • Runny nose • Itchy, watery eyes • Itchy throat or nose due to allergies INDOOR AND OUTDOOR ALLERGIES 30 EXTENDED-RELEASE TABLETS ACTUAL SIZE *Compare to the active ingredients of Allegra-D ® Do not use if individual blister unit is open or torn. PRINCIPAL DISPLAY PANEL - 30 Tablet Blister Pack Carton"],"pregnancy_or_breast_feeding":["If pregnant or breast feeding, ask a health professional before use. In case of overdose, get medical help or contact a Poison Control Center right away (1800-222-1222)"],"purpose":["Purpose Antihistamine Nasal Decongestant"],"set_id":"75236b23-af51-40b6-ad1b-f62a27093a16","spl_product_data_elements":["Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride fexofenadine hydrochloride and pseudoephedrine hydrochloride FEXOFENADINE HYDROCHLORIDE FEXOFENADINE PSEUDOEPHEDRINE HYDROCHLORIDE PSEUDOEPHEDRINE LACTOSE MONOHYDRATE MICROCRYSTALLINE CELLULOSE CROSCARMELLOSE SODIUM POVIDONE, UNSPECIFIED MAGNESIUM STEARATE DIBASIC CALCIUM PHOSPHATE DIHYDRATE SILICON DIOXIDE ETHYLCELLULOSE, UNSPECIFIED FERRIC OXIDE YELLOW STEARIC ACID HYPROMELLOSE, UNSPECIFIED POLYETHYLENE GLYCOL, UNSPECIFIED 724"],"spl_unclassified_section":["Drug Facts","DISTRIBUTED BY PUBLIX SUPER MARKETS, INC., 3300 PUBLIX CORPORATE PARKWAY LAKELAND, FL 33811"],"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"],"storage_and_handling":["Other information do not use if carton is opened or if individual blister units are torn or opened store between 68° to 77°F (20° to 25 °C) Meets dissolution test 6"],"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 ) 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 If pregnant or breast feeding, ask a health professional before use. In case of overdose, get medical help or contact a Poison Control Center right away (1800-222-1222) Keep Out of Reach of Children."],"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 )"]}