{"active_ingredient":["Active ingredients (in each tablet) Fexofenadine HCl 60 mg Pseudoephedrine HCl 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 styleCode=\"Noautorules\" width=\"100%\"><col width=\"38%\"/><col width=\"60%\"/><tbody><tr><td styleCode=\"Rrule Botrule Toprule \" valign=\"top\"><list listType=\"unordered\"><item><caption> </caption>adults and children 12 years of age and over</item></list></td><td styleCode=\"Botrule Lrule Toprule \" valign=\"top\"><list listType=\"unordered\"><item><caption> </caption>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</item></list></td></tr><tr><td styleCode=\"Rrule Botrule \" valign=\"top\"><list listType=\"unordered\"><item><caption> </caption>children under 12 years of age</item></list></td><td styleCode=\"Lrule Toprule Botrule \" valign=\"top\"><list listType=\"unordered\"><item><caption> </caption>do not use</item></list></td></tr><tr><td styleCode=\"Rrule Botrule \" valign=\"top\"><list listType=\"unordered\"><item><caption> </caption>adults 65 years of age and older</item></list></td><td styleCode=\"Lrule Toprule Botrule \" valign=\"top\"><list listType=\"unordered\"><item><caption> </caption>ask a doctor</item></list></td></tr><tr><td styleCode=\"Rrule Botrule Toprule \" valign=\"top\"><list listType=\"unordered\"><item><caption> </caption>consumers with kidney disease</item></list></td><td styleCode=\"Botrule Lrule Toprule \" valign=\"top\"><list listType=\"unordered\"><item><caption> </caption>ask a doctor</item></list></td></tr></tbody></table>"],"effective_time":"20260708","id":"35f93439-eed1-40f4-a792-7527fbf3c19a","inactive_ingredient":["Inactive ingredients colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10 aluminum lake, dibasic calcium phosphate dihydrate, FD&C blue #2 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch"],"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 right away (1-800-222-1222)."],"openfda":{"application_number":["ANDA216792"],"brand_name":["RUGBY ALLERGY RELIEF D"],"generic_name":["FEXOFENADINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["Rugby Laboratories"],"package_ndc":["0536-1491-34","0536-1491-07"],"product_ndc":["0536-1491"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["997406"],"spl_id":["35f93439-eed1-40f4-a792-7527fbf3c19a"],"spl_set_id":["35f93439-eed1-40f4-a792-7527fbf3c19a"],"substance_name":["FEXOFENADINE HYDROCHLORIDE","PSEUDOEPHEDRINE HYDROCHLORIDE"],"unii":["2S068B75ZU","6V9V2RYJ8N"]},"other_safety_information":["Other information • each tablet contains: calcium 21 mg • safety sealed: do not use if carton is opened or if individual blister units are torn or opened • store between 20° and 25°C (68° and 77°F) • meets USP Dissolution Test 2"],"package_label_principal_display_panel":["Package/Label Principal Display Panel Rugby® compare to the active ingredients in Allegra-D® Allergy & Congestion non-drowsy allergy relief D fexofenadine HCl 60 mg and pseudoephedrine HCl 120 mg extended release tablets antihistamine/nasal decongestant 12 HR allergy & congestion 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 actual size rugby-allergy-relief-d-carton-image.jpg"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Antihistamine Nasal decongestant"],"questions":["Questions or comments?"],"set_id":"35f93439-eed1-40f4-a792-7527fbf3c19a","spl_product_data_elements":["RUGBY ALLERGY RELIEF D fexofenadine hydrochloride, pseudoephedrine hydrochloride FEXOFENADINE HYDROCHLORIDE FEXOFENADINE PSEUDOEPHEDRINE HYDROCHLORIDE PSEUDOEPHEDRINE SILICON DIOXIDE CROSCARMELLOSE SODIUM D&C YELLOW NO. 10 ALUMINUM LAKE DIBASIC CALCIUM PHOSPHATE DIHYDRATE FD&C BLUE NO. 2 ALUMINUM LAKE FD&C YELLOW NO. 6 ALUMINUM LAKE HYPROMELLOSE, UNSPECIFIED LACTOSE MONOHYDRATE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED 5U0"],"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 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 take as directed (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. 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 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)."]}