{"active_ingredient":["Active ingredients (in each 5 mL, 1 teaspoon) Dextromethorphan HBr, 10 mg Guaifenesin, 100 mg Phenylephrine HCl, 5 mg"],"dosage_and_administration":["Directions • do not take more than 6 doses in any 24-hour period. • mL = milliliter age dose Adults and Children 12 years of age and over 2 teaspoons (10 mL) every 4 hours Children 6 to under 12 years of age 1 teaspoon (5 mL) every 4 hours Children under 6 years of age do not use"],"dosage_and_administration_table":["<table width=\"50%\"><tbody><tr><td styleCode=\"Botrule Lrule Rrule Toprule\" align=\"center\"> age</td><td styleCode=\"Botrule Lrule Rrule Toprule\" align=\"center\"> dose</td></tr><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\"> 2 teaspoons (10 mL) every 4 hours</td></tr><tr><td styleCode=\"Botrule Lrule Rrule Toprule\" align=\"center\"> Children 6 to under 12 years of age</td><td styleCode=\"Botrule Lrule Rrule Toprule\" align=\"center\"> 1 teaspoon (5 mL) every 4 hours</td></tr><tr><td styleCode=\"Botrule Lrule Rrule Toprule\" align=\"center\"> Children under 6 years of age</td><td styleCode=\"Botrule Lrule Rrule Toprule\" align=\"center\"> do not use</td></tr></tbody></table>"],"effective_time":"20251112","id":"affd083a-31b7-4862-ac14-e4ccc4d2ca7e","inactive_ingredient":["Inactive ingredients citric acid, flavor, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sucralose."],"indications_and_usage":["Uses • suppresses cough due to minor throat and bronchial irritation associated with a cold or inhaled irritants • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus, drain bronchial tubes, and make coughs more productive • temporarily relieves nasal congestion due to a cold"],"keep_out_of_reach_of_children":["Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away."],"openfda":{"application_number":["M012"],"brand_name":["DESGEN DM"],"generic_name":["DEXTROMETHORPHAN HBR ,GUAIFENESIN ,PHENYLEPHRINE HCL"],"is_original_packager":[true],"manufacturer_name":["Kramer Novis"],"nui":["N0000193956","N0000008867","N0000009560"],"package_ndc":["52083-646-16"],"pharm_class_epc":["Expectorant [EPC]"],"pharm_class_pe":["Decreased Respiratory Secretion Viscosity [PE]","Increased Respiratory Secretions [PE]"],"product_ndc":["52083-646"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1044949"],"spl_id":["affd083a-31b7-4862-ac14-e4ccc4d2ca7e"],"spl_set_id":["6ab47174-e1fd-47ce-8788-06b7cdad5218"],"substance_name":["DEXTROMETHORPHAN HYDROBROMIDE","GUAIFENESIN","PHENYLEPHRINE HYDROCHLORIDE"],"unii":["9D2RTI9KYH","495W7451VQ","04JA59TNSJ"],"upc":["0352083646164"]},"package_label_principal_display_panel":["Packaging DESGEN DM"],"purpose":["Purposes Cough Suppressant Expectorant Nasal Decongestant"],"questions":["Questions or comments? 1-787-767-2072 Call weekdays from 8AM to 4PM AST."],"set_id":"6ab47174-e1fd-47ce-8788-06b7cdad5218","spl_product_data_elements":["DESGEN DM Dextromethorphan HBr ,Guaifenesin ,Phenylephrine HCl DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE CITRIC ACID MONOHYDRATE GLYCERIN METHYLPARABEN PROPYLENE GLYCOL PROPYLPARABEN WATER SODIUM CITRATE, UNSPECIFIED FORM SUCRALOSE"],"spl_unclassified_section":["Drug Facts","NEW FORMULA COUGH SUPPRESSANT Dextromethorphan HBr EXPECTORANT Guaifenesin NASAL DECONGESTANT Phenylephrine HCl Contains the same active ingredients as Despec® DM * SUGAR FREE DYE FREE ALCOHOL FREE GRAPE FLAVOR Kramer Novis Pharmaceuticals within reach of patients * Despec® DM is a Registered Trademark of International Ethical Laboratories, Inc. This product is not manufactured, distributed or marketed by International Ethical Laboratories, Inc. Manufactured in USA with imported ingredients for Kramer Novis. San Juan, PR 00917 www.kramernovis.com"],"storage_and_handling":["Other information • Tamper evident feature: Do not use if security seal is torn, broken or missing. • Store at controlled room temperature 15-30°C (59-86°F) • Avoid excessive heat or humidity."],"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. Ask a doctor before use if you have • diabetes • heart disease • thyroid disease • high blood pressure • 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. When using this product do not use more than directed. 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 accidental overdose, get medical help or contact a Poison Control Center right away."]}