{"active_ingredient":["Active ingredient (in each 5 mL) Dextromethorphan polistirex equivalent to 30 mg dextromethorphan hydrobromide"],"ask_doctor":["Ask a doctor before use if you have • chronic cough that lasts as occurs with smoking, asthma or emphysema • cough that occurs with too much phlegm (mucus)"],"do_not_use":["Do not use 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. Allergy Alert: Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions."],"dosage_and_administration":["Directions • shake bottle well before use • measure only with dosing cup provided • do not use dosing cup with other products • dose as follows or as directed by doctor • mL = milliliter adults and children 12 years of age and over 10 mL every 12 hours, not to exceed 20 mL in 24 hours children 6 to under 12 years of age 5 mL every 12 hours, not to exceed 10 mL in 24 hours children 4 to under 6 years of age 2.5 mL every 12 hours, not to exceed 5 mL in 24 hours children under 4 years of age do not use"],"dosage_and_administration_table":["<table width=\"100%\"> <col width=\"50%\"/> <col width=\"50%\"/> <tbody> <tr> <td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"> <paragraph>adults and children 12 years of age and over</paragraph> </td> <td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"> <paragraph>10 mL every 12 hours, not to exceed 20 mL in 24 hours</paragraph> </td> </tr> <tr> <td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"> <paragraph>children 6 to under 12 years of age</paragraph> </td> <td styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"> <paragraph>5 mL every 12 hours, not to exceed 10 mL in 24 hours</paragraph> </td> </tr> <tr> <td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"> <paragraph>children 4 to under 6 years of age</paragraph> </td> <td styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"> <paragraph>2.5 mL every 12 hours, not to exceed 5 mL in 24 hours</paragraph> </td> </tr> <tr> <td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"> <paragraph>children under 4 years of age</paragraph> </td> <td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"> <paragraph>do not use</paragraph> </td> </tr> </tbody> </table>"],"effective_time":"20170713","how_supplied":["HOW SUPPLIED Product: 50436-0433 NDC: 50436-0433-1 89 mL in a BOTTLE"],"id":"de7deea7-e574-4b93-ba10-65a446e7f2ff","inactive_ingredient":["Inactive Ingredients D&C Red #30 aluminum lake, D&C Yellow #10 aluminum lake, flavor, glycerin, high fructose corn syrup, methylparaben, polysorbate 80, polyvinyl acetate, povidone, propylparaben, purified water, sodium metabisulfite, sodium polystyrene sulfonate, sucrose, tartaric acid, tragacanth gum, triacetin, xanthan gum"],"indications_and_usage":["Uses temporarily relieves • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants • the impulse to cough to help you get to sleep"],"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":{},"package_label_principal_display_panel":["DEXTROMETHORPHAN POLISTIREX EXTENDED RELEASE (DEXTROMETHORPHAN POLISTIREX) SUSPENSION Label Image"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Cough suppressant"],"questions":["Questions or comments? 1-800-719-9260"],"set_id":"8007a226-f0d2-4618-af13-33c807f36ab5","spl_product_data_elements":["dextromethorphan polistirex extended release dextromethorphan polistirex DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN POLISTIREX D&C RED NO. 30 D&C YELLOW NO. 10 GLYCERIN HIGH FRUCTOSE CORN SYRUP METHYLPARABEN POLYSORBATE 80 POLYVINYL ACETATE POVIDONE, UNSPECIFIED PROPYLPARABEN WATER SODIUM METABISULFITE SODIUM POLYSTYRENE SULFONATE SUCROSE TARTARIC ACID TRAGACANTH TRIACETIN XANTHAN GUM"],"spl_unclassified_section":["Other information • each 5 mL contains: sodium 5 mg • store at 20 ° to 25 ° C (68 ° to 77 ° F) • dosing cup provided"],"stop_use":["Stop use and ask a doctor if • side effects occur. You may report side effects to FDA at 1-800-FDA-1088. • cough lasts more than 7 days, cough comes back, or occurs with fever, rash or headache that lasts. These could be signs of a serious condition."],"version":"2","warnings":["Warnings Do not use 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. Allergy Alert: Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions. Ask a doctor before use if you have • chronic cough that lasts as occurs with smoking, asthma or emphysema • cough that occurs with too much phlegm (mucus) Stop use and ask a doctor if • side effects occur. You may report side effects to FDA at 1-800-FDA-1088. • cough lasts more than 7 days, cough comes back, or occurs with fever, rash or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use."]}