{"active_ingredient":["Active Ingredients (in each tablet) Purpose Chlorpheniramine Maleate 4 mg Antihistamine Phenylephrine HCl 10 mg Nasal Decongestant"],"active_ingredient_table":["<table width=\"100%\"> <col width=\"60%\"/> <col width=\"40%\"/> <thead> <tr> <th align=\"left\" styleCode=\"Botrule Toprule \" valign=\"top\"> <content styleCode=\"bold\"> <content styleCode=\"italics\">Active Ingredients (in each tablet)</content> </content> </th> <th align=\"left\" styleCode=\"Botrule Toprule \" valign=\"top\"> <content styleCode=\"bold\"> <content styleCode=\"italics\">Purpose</content> </content> </th> </tr> </thead> <tbody> <tr> <td styleCode=\"Toprule \" valign=\"top\"> <paragraph>Chlorpheniramine Maleate 4 mg</paragraph> </td> <td styleCode=\"Toprule \" valign=\"top\"> <paragraph>Antihistamine</paragraph> </td> </tr> <tr> <td styleCode=\"Botrule \" valign=\"top\"> <paragraph>Phenylephrine HCl 10 mg</paragraph> </td> <td styleCode=\"Botrule \" valign=\"top\"> <paragraph>Nasal Decongestant</paragraph> </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 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 is 24 hours, or as directed by a doctor Children under 6 years of age: Consult a doctor."],"dosage_and_administration_table":["<table width=\"100%\"> <col width=\"40%\"/> <col width=\"60%\"/> <tbody> <tr> <td styleCode=\"Rrule Botrule Toprule \" valign=\"top\"> <paragraph>Adults and children 12 years of age and over:</paragraph> </td> <td styleCode=\"Botrule Toprule \" valign=\"top\"> <paragraph>1 tablet every 4 hours, not to exceed 6 tablets in 24 hours, or as directed by a doctor</paragraph> </td> </tr> <tr> <td styleCode=\"Rrule Botrule \" valign=\"top\"> <paragraph>Children 6 to under 12 years of age:</paragraph> </td> <td styleCode=\"Botrule \" valign=\"top\"> <paragraph>1/2 tablet every 4 hours, not to exceed 3 tablets is 24 hours, or as directed by a doctor</paragraph> </td> </tr> <tr> <td styleCode=\"Rrule Botrule \" valign=\"top\"> <paragraph>Children under 6 years of age:</paragraph> </td> <td styleCode=\"Botrule \" valign=\"top\"> <paragraph>Consult a doctor.</paragraph> </td> </tr> </tbody> </table>"],"effective_time":"20170628","id":"3479f94d-979c-44c0-b19c-dab9024a3193","inactive_ingredient":["Inactive ingredients FD&C Blue #2, FD&C Yellow #5, FD&C Yellow #6, 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 0485-0254-01 ED A-HIST TABLETS Antihistamine • Nasal Decongestant Each tablet contains: Chlorpheniramine Maleate 4 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 Label"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Active Ingredients (in each tablet) Purpose Chlorpheniramine Maleate 4 mg Antihistamine Phenylephrine HCl 10 mg Nasal Decongestant"],"purpose_table":["<table width=\"100%\"> <col width=\"60%\"/> <col width=\"40%\"/> <thead> <tr> <th align=\"left\" styleCode=\"Botrule Toprule \" valign=\"top\"> <content styleCode=\"bold\"> <content styleCode=\"italics\">Active Ingredients (in each tablet)</content> </content> </th> <th align=\"left\" styleCode=\"Botrule Toprule \" valign=\"top\"> <content styleCode=\"bold\"> <content styleCode=\"italics\">Purpose</content> </content> </th> </tr> </thead> <tbody> <tr> <td styleCode=\"Toprule \" valign=\"top\"> <paragraph>Chlorpheniramine Maleate 4 mg</paragraph> </td> <td styleCode=\"Toprule \" valign=\"top\"> <paragraph>Antihistamine</paragraph> </td> </tr> <tr> <td styleCode=\"Botrule \" valign=\"top\"> <paragraph>Phenylephrine HCl 10 mg</paragraph> </td> <td styleCode=\"Botrule \" valign=\"top\"> <paragraph>Nasal Decongestant</paragraph> </td> </tr> </tbody> </table>"],"questions":["Questions or Comments? Call 1-800-543-9560 Rev."],"set_id":"f5b58cba-368b-4d32-8aa3-fabed2b26072","spl_product_data_elements":["ED A-HIST CHLORPHENIRAMINE MALEATE and PHENYLEPHRINE HYDROCHLORIDE CHLORPHENIRAMINE MALEATE CHLORPHENIRAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE FD&C BLUE NO. 2 FD&C YELLOW NO. 5 FD&C YELLOW NO. 6 MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE SODIUM STARCH GLYCOLATE TYPE A CORN WHEAT E;1"],"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 a fever • new symptoms occur"],"version":"2","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 the 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 a 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 the drowsiness effect • avoid alcoholic beverages • use caution when driving a motor vehicle or operating machinery"]}