{"active_ingredient":["OTC - ACTIVE INGREDIENT Active ingredient (in each 5 mL) Dextromethorphan polistirex equivalent to 30 mg dextromethorphan hydrobromide, USP"],"ask_doctor":["OTC - ASK DOCTOR Ask a doctor before use if you have chronic cough that lasts such as occurs with smoking, asthma or emphysema cough that occurs with too much phlegm (mucus) Stop use and ask a doctor if 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."],"do_not_use":["OTC - 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."],"dosage_and_administration":["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 a 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 Other information each 5 mL contains: sodium 7 mg store at 20° to 25°C (68° to 77°F) dosing cup provided"],"dosage_and_administration_table":["<table><col/><col/><tbody><tr><td styleCode=\" Botrule Toprule Lrule Rrule\"> adults and children 12 years of age and over</td><td styleCode=\" Botrule Toprule Lrule Rrule\"> 10 mL every 12 hours,   not to exceed 20 mL in 24 hours</td></tr><tr><td styleCode=\" Botrule Toprule Lrule Rrule\"> children 6 to under 12 years of age</td><td styleCode=\" Botrule Toprule Lrule Rrule\"> 5 mL every 12 hours,   not to exceed 10 mL in 24 hours</td></tr><tr><td styleCode=\" Botrule Toprule Lrule Rrule\"> children 4 to under 6 years of age</td><td styleCode=\" Botrule Toprule Lrule Rrule\"> 2.5 mL every 12 hours,  not to exceed 5 mL in 24 hours</td></tr><tr><td styleCode=\" Botrule Toprule Lrule Rrule\"> children under 4 years of age</td><td styleCode=\" Botrule Toprule Lrule Rrule\"> do not use</td></tr></tbody></table>"],"effective_time":"20240627","id":"9eb36122-c3bf-4b04-84a1-bb137f884c40","inactive_ingredient":["INACTIVE INGREDIENT Inactive ingredients citric acid, corn oil, D&C Red No. 33, edetate disodium, ethylcellulose, FD&C Blue No. 1, flavors, methylparaben, polyethylene glycol 3350, polysorbate 80, propylene glycol, propylparaben, purified water, sodium polystyrene sulfonate, sucrose, tragacanth, xanthan gum Hydrochloric acid or sodium hydroxide solution, if required, to adjust the pH."],"indications_and_usage":["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":["OTC - 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."],"openfda":{"application_number":["ANDA203133"],"brand_name":["Dextromethorphan Polistirex Extended-Release"],"generic_name":["DEXTROMETHORPHAN POLISTIREX"],"is_original_packager":[true],"manufacturer_name":["Amneal Pharmaceuticals LLC"],"package_ndc":["65162-799-76","65162-799-77"],"product_ndc":["65162-799"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1373045"],"spl_id":["9eb36122-c3bf-4b04-84a1-bb137f884c40"],"spl_set_id":["e0104a59-0bc2-4401-8c14-7f28499dbac6"],"substance_name":["DEXTROMETHORPHAN HYDROBROMIDE"],"unii":["9D2RTI9KYH"]},"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 30 mg/5 mL 3oz Label 30 mg/5 mL 3oz Carton"],"pregnancy_or_breast_feeding":["OTC - PREGNANCY OR BREAST FEEDING If pregnant or breast-feeding, ask a health professional before use."],"purpose":["OTC - PURPOSE Purpose Cough suppressant"],"questions":["OTC - QUESTIONS Questions? Call 1-877-835-5472, Mon through Fri 9AM to 5PM EST. Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 06-2024-01"],"set_id":"e0104a59-0bc2-4401-8c14-7f28499dbac6","spl_product_data_elements":["Dextromethorphan Polistirex Extended-Release Dextromethorphan Polistirex DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN SODIUM POLYSTYRENE SULFONATE CITRIC ACID MONOHYDRATE CORN OIL D&C RED NO. 33 EDETATE DISODIUM ETHYLCELLULOSES FD&C BLUE NO. 1 METHYLPARABEN POLYETHYLENE GLYCOL 3350 POLYSORBATE 80 PROPYLENE GLYCOL PROPYLPARABEN WATER SUCROSE TRAGACANTH XANTHAN GUM HYDROCHLORIC ACID SODIUM HYDROXIDE"],"spl_unclassified_section":["Drug Facts"],"version":"10","warnings":["WARNINGS Warnings"]}