{"active_ingredient":["Active Ingredients (in each tablet) Purpose Pseudoephedrine HCI 60 mg Nasal Decongestant Triprolidine HCI 2.5 mg. Antihistamine"],"active_ingredient_table":["<table width=\"60%\"><col width=\"65%\" align=\"left\" valign=\"top\"/><col width=\"35%\" align=\"right\" valign=\"top\"/><thead><tr><th><content styleCode=\"italics\">Active Ingredients (in each tablet)</content></th><th><content styleCode=\"italics\">Purpose</content></th></tr></thead><tbody><tr><td>Pseudoephedrine HCI 60 mg</td><td>Nasal Decongestant</td></tr><tr><td>Triprolidine HCI 2.5 mg.</td><td>Antihistamine</td></tr></tbody></table>"],"ask_doctor":["Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis glaucoma heart disease high blood pressure thyroid disease diabetes mellitus difficulty in urination due to enlargement of the prostate gland"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers"],"do_not_use":["Do not use this product 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 exceed recommended dosage. Adults and children 12 years of age and over: 1 tablet every 4-6 hours, not to exceed 4 tablets in 24 hours, or as directed by a doctor Children 6 to under 12 years of age: 1/2 tablet every 4-6 hours, not to exceed 2 tablets in 24 hours, or as directed by a doctor Children under 6 years of age: Consult a doctor."],"dosage_and_administration_table":["<table width=\"50%\" styleCode=\"Noautorules\"><col width=\"40%\" align=\"left\" valign=\"top\"/><col width=\"60%\" align=\"left\" valign=\"top\"/><tbody><tr><td styleCode=\"Botrule Rrule Toprule\">Adults and children 12 years of age and over:</td><td styleCode=\"Botrule Toprule\">1 tablet every 4-6 hours, not to exceed 4 tablets in 24 hours, or as directed by a doctor</td></tr><tr><td styleCode=\"Botrule Rrule\">Children 6 to under 12 years of age:</td><td styleCode=\"Botrule\">1/2 tablet every 4-6 hours, not to exceed 2 tablets in 24 hours, or as directed by a doctor</td></tr><tr><td styleCode=\"Rrule\">Children under 6 years of age:</td><td>Consult a doctor.</td></tr></tbody></table>"],"effective_time":"20220113","id":"d57f830b-52d0-0fd2-e053-2995a90a8a7a","inactive_ingredient":["Inactive ingredients FD&C Blue #2, FD&C Yellow #5, Magnesium Stearate, Microcrystalline Cellulose, Sodium Starch Glycolate. Contains FD&C Yellow No. 5 (tartrazine) as a color additive."],"indications_and_usage":["Uses temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies: runny nose sneezing itching of the nose or throat itchy, watery eyes nasal congestion reduces swelling of nasal passages"],"keep_out_of_reach_of_children":["Keep out of reach of children. In case of accidental overdose, seek professional help or contact a Poison Control Center immediately."],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label NDC 00485-0210-01 ED A-HIST PSE TABLETS Nasal Decongestant • Antihistamine Each tablet contains: Pseudoephedrine HCI 60 mg Triprolidine HCI 2.5 mg This bottle is not to be dispensed to consumer. Dispense in a tight, light-resistant container with a child-resistant cap. Store at 59°-86°F (15°-30°C) (see USP Controlled Room Temperature]. Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing. Manufactured for: EDWARDS Pharmaceuticals, Inc . Ripley, MS 38663 100 tablets Principal Display Panel - 100 Tablet Bottle Label"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use,"],"purpose":["Active Ingredients (in each tablet) Purpose Pseudoephedrine HCI 60 mg Nasal Decongestant Triprolidine HCI 2.5 mg. Antihistamine"],"purpose_table":["<table width=\"60%\"><col width=\"65%\" align=\"left\" valign=\"top\"/><col width=\"35%\" align=\"right\" valign=\"top\"/><thead><tr><th><content styleCode=\"italics\">Active Ingredients (in each tablet)</content></th><th><content styleCode=\"italics\">Purpose</content></th></tr></thead><tbody><tr><td>Pseudoephedrine HCI 60 mg</td><td>Nasal Decongestant</td></tr><tr><td>Triprolidine HCI 2.5 mg.</td><td>Antihistamine</td></tr></tbody></table>"],"questions":["Questions or Comments? Call 1-800-543-9560 Rev. 11/11"],"set_id":"b0c6ef78-0f82-4ff7-a988-b11f99094843","spl_product_data_elements":["ED-A-HIST PSE PSEUDOEPHEDRINE HYDROCHLORIDE and TRIPROLIDINE HYDROCHLORIDE FD&C BLUE NO. 2 FD&C YELLOW NO. 5 MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE SODIUM STARCH GLYCOLATE TYPE A CORN PSEUDOEPHEDRINE HYDROCHLORIDE PSEUDOEPHEDRINE TRIPROLIDINE HYDROCHLORIDE TRIPROLIDINE ED;PSE"],"spl_unclassified_section":["Drug Facts"],"stop_use":["Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur symptoms do not improve within 7 days or are accompanied by fever new symptoms occur"],"version":"4","warnings":["Warnings Do not exceed recommended dosage. Do not use this product 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 a breathing problem such as emphysema or chronic bronchitis glaucoma heart disease high blood pressure thyroid disease diabetes mellitus difficulty in urination due to enlargement of the prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers When using this product excitability may occur, especially in children may cause drowsiness alcohol, sedatives and tranquilizers may increase drowsiness effect avoid alcoholic beverages use caution when driving a motor vehicle or operating machinery Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur symptoms do not improve within 7 days or are accompanied by fever new symptoms occur If pregnant or breast-feeding, ask a health professional before use, Keep out of reach of children. In case of accidental overdose, seek professional help or contact a Poison Control Center immediately."],"when_using":["When using this product excitability may occur, especially in children may cause drowsiness alcohol, sedatives and tranquilizers may increase drowsiness effect avoid alcoholic beverages use caution when driving a motor vehicle or operating machinery"]}