{"active_ingredient":["Active ingredient (in each 5 mL) Dextromethorphan polistirex equivalent to 30 mg dextromethorphan hydrobromide USP"],"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)"],"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"],"dosage_and_administration_table":["
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
"],"effective_time":"20260504","id":"e568400c-98ea-4f20-be34-1fb3e05bb72b","inactive_ingredient":["Inactive ingredients citric acid anhydrous, D&C Red no.33, edetate disodium, ethylcellulose, FD & C Blue no. 1, FD & C Red no. 40, grape flavour, high fructose corn syrup, methylparaben, polyethylene glycol, polysorbate 80, propylene glycol, purified water, sucrose, tragacanth, 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 (1-800-222-1222) right away."],"openfda":{"application_number":["ANDA218417"],"brand_name":["DEXTROMETHORPHAN POLISTIREX"],"generic_name":["DEXTROMETHORPHAN POLISTIREX"],"is_original_packager":[true],"manufacturer_name":["Aurohealth LLC"],"nui":["N0000181821","N0000182149","N0000181819","N0000182147"],"package_ndc":["58602-611-05","58602-611-06"],"pharm_class_epc":["Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]","Sigma-1 Agonist [EPC]"],"pharm_class_moa":["Uncompetitive NMDA Receptor Antagonists [MoA]","Sigma-1 Receptor Agonists [MoA]"],"product_ndc":["58602-611"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1373045"],"spl_id":["e568400c-98ea-4f20-be34-1fb3e05bb72b"],"spl_set_id":["759acdcd-d8d0-41d0-8b80-7f81fe196a9f"],"substance_name":["DEXTROMETHORPHAN"],"unii":["7355X3ROTS"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 89 mL (3 fl oz) Bottle Label AUROHEALTH NDC 58602-611-05 CHILDREN'S COUGH SUPPRESSANT Dextromethorphan Polistirex Extended-Release Oral Suspension 30 mg/5 mL COUGH AGES 4+ 12 HOUR RELIEF CONTAINS NO FEVER REDUCER OR PAIN RELIEVER DAY or NIGHT ALCOHOL FREE Grape Flavored Liquid For Children & Adults 89 mL (3 fl oz) PRINCIPAL DISPLAY PANEL - 89 mL (3 fl oz) Bottle Label","PRINCIPAL DISPLAY PANEL - 89 mL (3 fl oz) Bottle Carton Label NDC 58602-611-05 Compare to Children's Delsym ® active ingredient* AUROHEALTH CHILDREN'S COUGH SUPPRESSANT Dextromethorphan Polistirex Extended-Release Oral Suspension 30 mg/5 mL COUGH DAY or NIGHT Alcohol Free For Children & Adults AGES 4+ 12 HOUR RELIEF Grape Flavored Liquid 89 mL (3 fl oz) PRINCIPAL DISPLAY PANEL - 89 mL (3 fl oz) Bottle Carton Label"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Cough suppressant"],"questions":["Questions or comments? call 1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST) Distributed by: AUROHEALTH LLC 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India"],"set_id":"759acdcd-d8d0-41d0-8b80-7f81fe196a9f","spl_product_data_elements":["DEXTROMETHORPHAN POLISTIREX DEXTROMETHORPHAN POLISTIREX DEXTROMETHORPHAN DEXTROMETHORPHAN DEXTROMETHORPHAN HYDROBROMIDE POLISTIREX ANHYDROUS CITRIC ACID D&C RED NO. 33 EDETATE DISODIUM ETHYLCELLULOSE AQUEOUS DISPERSION TYPE B FD&C BLUE NO. 1 FD&C RED NO. 40 GRAPE HIGH FRUCTOSE CORN SYRUP METHYLPARABEN POLYETHYLENE GLYCOL 6000 POLYSORBATE 80 PROPYLENE GLYCOL WATER SUCROSE TRAGACANTH XANTHAN GUM Purple to dark purple"],"spl_unclassified_section":["Drug Facts","Other information each 5 mL contains: sodium 5 mg store at 20º to 25°C (68º to 77°F) dosing cup provided"],"stop_use":["Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition."],"version":"3","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."]}