{"active_ingredient":["Active ingredients (in each 5 mL tsp) Dextromethorphan HBr, 30 mg Guaifenesin, 200 mg Phenylephrine HCl, 10 mg"],"dosage_and_administration":["Directions • do not take more than 4 doses in any 24-hour period. AGE DOSE Adults and Children 12 years of age and over Take 1 teaspoonfuls (5 mL) every 6 hours Children under 12 years of age ask a doctor"],"dosage_and_administration_table":["<table width=\"50%\"><tbody><tr><td styleCode=\"Botrule Lrule Rrule\" align=\"center\"><content styleCode=\"italics\"><content styleCode=\"bold\">AGE</content></content></td><td styleCode=\"Botrule Rrule\" align=\"center\"><content styleCode=\"italics\"><content styleCode=\"bold\">DOSE</content></content></td></tr><tr><td styleCode=\"Botrule Lrule Rrule\" align=\"center\"><paragraph>Adults and Children 12 years</paragraph><paragraph>of age and over </paragraph></td><td styleCode=\"Botrule Rrule\" align=\"center\"><paragraph> Take 1 teaspoonfuls</paragraph><paragraph>(5 mL) every 6 hours</paragraph></td></tr><tr><td styleCode=\"Lrule Rrule\" align=\"center\"><paragraph> Children under 12 years of</paragraph><paragraph> age</paragraph></td><td styleCode=\"Rrule\" align=\"center\">ask a doctor </td></tr></tbody></table>"],"effective_time":"20240628","id":"07838a85-4ddc-470d-a344-001587f2d904","inactive_ingredient":["Inactive ingredients Citric acid, D&C Red #40, FD&C Blue #1, flavor, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sucralose."],"indications_and_usage":["Uses • Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes • Temporarily relieves these symptoms occurring with a cold: • nasal congestion • cough due to minor throat and bronchial irritation."],"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":["ACTIDOM DMX"],"generic_name":["DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["ACTIPHARMA, LLC"],"nui":["N0000193956","N0000008867","N0000009560"],"package_ndc":["63102-110-16"],"pharm_class_epc":["Expectorant [EPC]"],"pharm_class_pe":["Decreased Respiratory Secretion Viscosity [PE]","Increased Respiratory Secretions [PE]"],"product_ndc":["63102-110"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1364914"],"spl_id":["07838a85-4ddc-470d-a344-001587f2d904"],"spl_set_id":["0166322e-7dbb-4658-a5c5-1d0525bb7655"],"substance_name":["DEXTROMETHORPHAN HYDROBROMIDE","GUAIFENESIN","PHENYLEPHRINE HYDROCHLORIDE"],"unii":["9D2RTI9KYH","495W7451VQ","04JA59TNSJ"]},"package_label_principal_display_panel":["Packaging Actidom DMX"],"purpose":["Purposes Cough suppressant Expectorant Nasal decongestant"],"questions":["Questions or comments? call weekdays from 8AM to 4PM AST at 1.787.608.0882"],"set_id":"0166322e-7dbb-4658-a5c5-1d0525bb7655","spl_product_data_elements":["ACTIDOM DMX DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE CITRIC ACID MONOHYDRATE FD&C RED NO. 40 FD&C BLUE NO. 1 GLYCERIN METHYLPARABEN PROPYLENE GLYCOL PROPYLPARABEN WATER SODIUM CITRATE, UNSPECIFIED FORM SUCRALOSE Clear"],"spl_unclassified_section":["Drug Facts","Contains the same active ingredients as Dometuss ® -DMX* SUGAR FREE ALCOHOL FREE Grape Flavor Manufactured in USA with imported ingredients for ActiPharma. San Juan, PR 00917. www.actipharma.net. * Dometuss® DMX is a registered trademark of Domel Laboratories. This product is not manufactured, distributed or marketed by Domel Laboratories."],"storage_and_handling":["Other information • Tamper Evident Feature: Do not use if safety seal is torn, cut or opened. • Store at controlled room temperature 15° - 30ºC (59º - 86ºF). • Avoid excessive heat or humidity."],"version":"4","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 you have • heart disease • high blood pressure • thyroid disease • diabetes • trouble urinating due to an enlarged prostate gland • cough that occurs with too much phlegm (mucus) • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema. Ask a doctor or pharmacist before use if you are taking any other oral nasal decongestant or stimulant. When using this product • do not exceed recommended dosage Stop use and ask a doctor if • you get nervous, dizzy or sleepless • symptoms do not get better within 7 days or are accompanied by fever • coughs lasts more than 7 days, comes back, 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."]}