{"active_ingredient":["​Active ingredients (in each 5 mL teaspoonful) Dextromethorphan HBr 10 mg Guaifenesin 100 mg"],"dosage_and_administration":["​Directions • do not exceed 6 doses in any 24-hour period. • mL = milliliter, tsp = teaspoon adults and children 12 years of age and over 10 mL (2 tsp) every 4 hours children under 12 years of age consult a doctor"],"dosage_and_administration_table":["<table width=\"50%\"><tbody><tr><td styleCode=\"Botrule Lrule Rrule Toprule\" align=\"center\"> adults and children 12 years of age and over</td><td styleCode=\"Botrule Lrule Rrule Toprule\" align=\"center\"> 10 mL (2 tsp) every 4 hours</td></tr><tr><td styleCode=\"Botrule Lrule Rrule Toprule\" align=\"center\"> children under 12 years of age</td><td styleCode=\"Botrule Lrule Rrule Toprule\" align=\"center\"> consult a doctor</td></tr></tbody></table>"],"effective_time":"20260115","id":"f35e67f4-4a6e-4340-9b6d-60cdbf33b412","inactive_ingredient":["​Inactive ingredients citric acid, flavor, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sucralose"],"indications_and_usage":["​ ​Uses • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive • temporarily relieves cough due to minor throat and bronchial irritation associated with a cold or inhaled irritants"],"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":["M012"],"brand_name":["ACTINEL Diabetic"],"generic_name":["DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN"],"is_original_packager":[true],"manufacturer_name":["ACTIPHARMA, LLC"],"nui":["N0000193956","N0000008867","N0000009560"],"package_ndc":["63102-140-16"],"pharm_class_epc":["Expectorant [EPC]"],"pharm_class_pe":["Decreased Respiratory Secretion Viscosity [PE]","Increased Respiratory Secretions [PE]"],"product_ndc":["63102-140"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["996520"],"spl_id":["f35e67f4-4a6e-4340-9b6d-60cdbf33b412"],"spl_set_id":["35c21623-84dd-4151-b35b-e7d30b69c9c0"],"substance_name":["DEXTROMETHORPHAN HYDROBROMIDE","GUAIFENESIN"],"unii":["9D2RTI9KYH","495W7451VQ"]},"package_label_principal_display_panel":["Packaging ACTINELDiabetic"],"purpose":["​Purposes Cough suppressant Expectorant"],"questions":["​ ​Questions or comments? ​1.787.608.0082 You may also report serious side effects to this phone number. Call weekdays from 8AM to 4PM AST"],"set_id":"35c21623-84dd-4151-b35b-e7d30b69c9c0","spl_product_data_elements":["ACTINEL Diabetic Dextromethorphan Hydrobromide, Guaifenesin DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN CITRIC ACID MONOHYDRATE METHYLPARABEN PROPYLENE GLYCOL PROPYLPARABEN WATER SODIUM CITRATE, UNSPECIFIED FORM SUCRALOSE Strawberry Banana Flavor"],"spl_unclassified_section":["​Drug Facts","Alcohol FREE Dye FREE Sugar FREE Contains the same active ingredients as Tusnel ® Diabetic * ActiPharma COMMITTED TO HEALTH AND WELL-BEING WWW.ACTIPHARMA.NET Manufactured for ActiPharma San Juan, PR 00917 Manufactured in USA with imported ingredients * Tusnel® Diabetic is a registered trademark of Llorens Pharmaceutical. This product is not manufactured, distributed or marketed by Llorens Pharmaceutical."],"storage_and_handling":["​Other information • tamper evident feature: Do not use if inner seal is torn, cut, or opened • store at controlled room temperature 15° - 30°C (59° - 86°F) • avoid excessive heat or humidity"],"version":"1","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. ​Ask a doctor before use if • cough is accompanied by excessive phlegm (mucus) • persistent or chronic cough such occurs with smoking, asthma, or emphysema ​When using this product • ​do not exceed recommended dosage ​Stop use and ask a doctor if • cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash or a persistent headache, These could be signs of a serious condition. ​If pregnant or breast-feeding, ​ask a health professional before use. Keep out of reach of children. ​In case of overdose, get medical help or contact a Poison Control Center right away."]}