{"active_ingredient":["Active Ingredients (in each tablet) Purpose Chlorpheniramine Maleate 4 mg Antihistamine Dextromethorphan HBr 10 mg Antitussive Phenylephrine HCl 10 mg Nasal Decongestant"],"active_ingredient_table":["<table width=\"65%\"><col width=\"70%\" align=\"left\" valign=\"top\"/><col width=\"30%\" align=\"right\" valign=\"top\"/><thead><tr><th><content styleCode=\"bold\"><content styleCode=\"italics\">Active Ingredients (in each tablet)</content></content></th><th><content styleCode=\"bold\"><content styleCode=\"italics\">Purpose</content></content></th></tr></thead><tbody><tr><td>Chlorpheniramine Maleate 4 mg</td><td>Antihistamine</td></tr><tr><td>Dextromethorphan HBr 10 mg</td><td>Antitussive</td></tr><tr><td>Phenylephrine HCl 10 mg</td><td>Nasal Decongestant</td></tr></tbody></table>"],"ask_doctor":["Do not use this product, unless directed by a doctor, if you have a breathing problem such as emphysema or chronic bronchitis glaucoma a persistent or chronic cough that occurs with too much phlegm (mucus) heart disease high blood pressure thyroid disease diabetes mellitus difficulty in urination due to enlargement of the prostate gland"],"ask_doctor_or_pharmacist":["Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor."],"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 hours, not to exceed 6 tablets in 24 hours, or as directed by a doctor Children 6 to under 12 years of age: 1/2 tablet every 4 hours, not to exceed 3 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=\"55%\" styleCode=\"Noautorules\"><col width=\"40%\" align=\"left\" valign=\"top\"/><col width=\"60%\" align=\"left\" valign=\"top\"/><tbody><tr><td styleCode=\"Toprule Rrule\">Adults and children 12 years of age and over:</td><td styleCode=\"Toprule\">1 tablet every 4 hours, not to exceed 6 tablets in 24 hours, or as directed by a doctor</td></tr><tr><td styleCode=\"Toprule Rrule\">Children 6 to under 12 years of age:</td><td styleCode=\"Toprule\">1/2 tablet every 4 hours, not to exceed 3 tablets in 24 hours, or as directed by a doctor</td></tr><tr><td styleCode=\"Toprule Rrule\">Children under 6 years of age:</td><td styleCode=\"Toprule\">Consult a doctor.</td></tr></tbody></table>"],"effective_time":"20260304","id":"4c365b98-4b80-48a7-e063-6394a90ace20","inactive_ingredient":["Inactive ingredients Lake blend purple, magnesium stearate, microcrystalline cellulose, sodium starch glycolate"],"indications_and_usage":["Uses temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other respiratory allergies: runny nose sneezing itching of the nose or throat itchy, watery eyes cough due to minor throat and bronchial irritation 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":{"brand_name":["ED-A-HIST DM"],"generic_name":["CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["EDWARDS PHARMACEUTICALS, INC."],"package_ndc":["0485-0240-01"],"product_ndc":["0485-0240"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1593105"],"spl_id":["4c365b98-4b80-48a7-e063-6394a90ace20"],"spl_set_id":["07cd07a1-d84c-4a91-8fa6-5eb58dd23991"],"substance_name":["CHLORPHENIRAMINE MALEATE","DEXTROMETHORPHAN HYDROBROMIDE","PHENYLEPHRINE HYDROCHLORIDE"],"unii":["V1Q0O9OJ9Z","9D2RTI9KYH","04JA59TNSJ"],"upc":["0304850240013"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label NDC 0485-0240-01 ED A-HIST DM TABLETS Antihistamine • Antitussive • Nasal Decongestant Each tablet contains: Chlorpheniramine Maleate 4 mg Dextromethorphan HBr 10 mg Phenylephrine HCl 10 mg 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 breastfeeding, ask a health professional before use."],"purpose":["Active Ingredients (in each tablet) Purpose Chlorpheniramine Maleate 4 mg Antihistamine Dextromethorphan HBr 10 mg Antitussive Phenylephrine HCl 10 mg Nasal Decongestant"],"purpose_table":["<table width=\"65%\"><col width=\"70%\" align=\"left\" valign=\"top\"/><col width=\"30%\" align=\"right\" valign=\"top\"/><thead><tr><th><content styleCode=\"bold\"><content styleCode=\"italics\">Active Ingredients (in each tablet)</content></content></th><th><content styleCode=\"bold\"><content styleCode=\"italics\">Purpose</content></content></th></tr></thead><tbody><tr><td>Chlorpheniramine Maleate 4 mg</td><td>Antihistamine</td></tr><tr><td>Dextromethorphan HBr 10 mg</td><td>Antitussive</td></tr><tr><td>Phenylephrine HCl 10 mg</td><td>Nasal Decongestant</td></tr></tbody></table>"],"questions":["Questions or Comments? Call 1-800-543-9560 Rev. 08/14"],"set_id":"07cd07a1-d84c-4a91-8fa6-5eb58dd23991","spl_product_data_elements":["ED-A-HIST DM CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE SODIUM STARCH GLYCOLATE TYPE A CORN FD&C RED NO. 40 FD&C BLUE NO. 2 CHLORPHENIRAMINE MALEATE CHLORPHENIRAMINE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE ED;DM"],"spl_unclassified_section":["Drug Facts"],"stop_use":["Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache. These could be signs of a serious condition. new symptoms occur"],"version":"7","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 Do not use this product, unless directed by a doctor, if you have a breathing problem such as emphysema or chronic bronchitis glaucoma a persistent or chronic cough that occurs with too much phlegm (mucus) heart disease high blood pressure thyroid disease diabetes mellitus difficulty in urination due to enlargement of the prostate gland Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor. When using this product excitability may occur, especially in children may cause marked drowsiness 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 cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache. These could be signs of a serious condition. new symptoms occur If pregnant or breastfeeding, 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 marked drowsiness sedatives and tranquilizers may increase drowsiness effect avoid alcoholic beverages use caution when driving a motor vehicle or operating machinery"]}